Yearly Archives: 2015

Vision loss is as common a problem as dementia among older people. Photograph: John Stillwell/PA

A patient has become the first in the UK to receive an experimental stem cell treatment that has the potential to save the sight of hundreds of thousands of Britons.

By December, doctors will know whether the woman, who has age-related macular degeneration, has regained her sight after a successful operation at Moorfields Eye Hospital in London last month. Over 18 months, 10 patients will undergo the treatment.

The transplant involves eye cells, called retinal pigment epithelium, derived from stem cells and grown in the lab to form a patch that can be placed behind the retina during surgery.

Related: Stem cell therapy success in treatment of sight loss from macular degeneration

The potential is huge. Although the first patients have the wet form of macular degeneration, the doctors believe it might also eventually work for those who have the dry form, who are the vast majority of the UKs 700,000 sufferers.

The surgery is an exciting moment for the 10-year-old London Project to Cure Blindness, a collaboration between the hospital, the UCL Institute of Ophthalmology and the National Institute for Health Research, which was formed to find a cure for wet age-related macular degeneration, the more serious but less common form of the disease.

Prof Pete Coffey of UCL, one of the founders of the London Project, said he would not be working on the new treatment if he did not believe it would work. He hopes it could become a routine procedure for people afflicted by vision loss, which is as common a problem among older people as dementia.

It does involve an operation, but were trying to make it as straightforward as a cataract operation, he said. It will probably take 45 minutes to an hour. We could treat a substantial number of those patients.

First they have to get approval. The trial is not just about safety, but also efficacy. There will be a regulatory review after the first few transplants to ensure all is going well.

The group of patients chosen have the wet form of the disease and experienced sudden loss of vision within about six weeks. The support cells in the eye, which get rid of daily debris and allow the seeing part to function have died.

There is a possibility of restoring their vision, said Coffey. The aim of the transplant is to restore the support cells so the seeing part of the eye is not affected by what would become an increasingly toxic environment, causing deterioration and serious vision loss. The surgery is being performed by retinal surgeon Prof Lyndon Da Cruz from Moorfields, who is also a co-founder of the London Project.

The team chose people with this dramatic vision loss to see whether the experimental stem cell therapy would reverse the loss of vision. But in those with dry macular degeneration, said Coffey, the process is far slower, which would mean doctors could choose the time to intervene if the treatment works.

Helping people to regain their sight has long been one of the most hopeful prospects for stem cell transplantation. Other research groups have been trialling the use of stem cells in people with Stargardts disease, which destroys the vision at a much earlier age.

Stem cells have moved from the drawing board into human trials with incredible speed, scientists say. The first embryonic stem cell was derived in 1989. Using them in eyes was always going to have a big advantage over other prospects, because it is possible to transplant them without an all-out attack by the immune system, as would happen in other parts of the body. Most people who have any sort of transplant have to take drugs that suppress the immune system for the rest of their lives.

Just like conventional medicines, stem cell therapies will very likely have to be developed and marketed by large commercial concerns. The London Project has the US drug company Pfizer on board.

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Platelet Rich Plasma – PRP – New Jersey – Dr E Magaziner

By adminSeptember 25, 2015Platelet Rich Plasma Injections

Dr. E. Magaziner is a New Jersey pioneer in Platelet Rich Plasma PRP therapy and injections. From his North Brunswick, NJ center he and his staff have provided cutting-edge PRP treatments and therapy to hundreds of New Jersey patients.

In the 20th century the only treatments we had for pain problems was to give cortisone and anti-inflammatories such as Advil. In the 21st century its adll about growth factors, stem cells, and methods to repair and regenerate injured body parts. With these biologic therapies we use Platelet Rich Plasma PRP also known as Autologous Platelet Concentrate (APC) or Autologous Bone Marrow Aspirate (ABM) which contain the bodys growth factors and stem cells. We then transplant theses cells in a tissue matrix using ultrasound or fluoroscopic guidance to the site of tissue or cartilage injury.

These cells literally go to work to force that inured site to go thru a repair process. It usually it takes 5-7 monthly sessions for the tendon injury or arthritis pain to go away. It works reliably over 90% of the time. Dr. Magaziner has had patients with years of pain treated by other methods that were ineffective, get there problem cured. Patients who have been told they need a knee, hip or shoulder replacement are back to normal activity and practically pain free in a matter of months. Dr. Magaziner has treated patients locally throughout the New Jersey area and across the United states. Most are extremely satisfied with the results and have told him it was like a miracle.

Dr. Magaziner frequently uploads case studies he feels would help provide more detailed information on platelet rich plasma and PRP.

Because PRP carries the signaling proteins for healing just about anything in the body, it can treat a wide range of conditions such as:

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Platelet Rich Plasma - PRP - New Jersey - Dr E Magaziner

Knee Arthritis and Platelet-Rich Plasma Injections

By adminSeptember 25, 2015Platelet Rich Plasma Injections

If you dread walking across a parking lot or climbing stairs because of the pain youll suffer in your knees, then you are probably an arthritis sufferer.

And you want relief. Maybe youre at the end of your rope or just now starting to learn more about your condition and how to repair it.

Arthritis in the knee is usually a result of high-impact sports and repetitive actions like gymnastics or running. Up until now the way to treat arthritis in the knee involved nonsurgical therapies, drugs and surgery.

Platelet-rich plasma (PRP) injections where a patientsbloodisspun into a concentrated plasma are proving to be effective treatments (after all other methods have been tried in some circumstances), which doesnt involve surgery and a protracted recovery time.

Lets review these options before we talk about PRP therapy.

Nonsurgical Treatment

If you have osteoarthritis of the knee, you can take advantage of a wide range of treatment nonsurgical options.

Lifestyle modification like losing weight and minimizing the high-impact activities that cause you pain in your knees.

Exercise improves your strength, flexibility and range of motion.

Supportive devices like knee braces, canes and cushioned shoes.

Different people respond to different modifications so experiment until you find one that works for you.

Drug Treatments

Several types of drugs can be used in treating arthritis of the knee.

Corticosteroids are powerful anti-inflammatory agents that can be injected into the joint.

Viscosupplementation is where the quality of the joint is improved by injecting it with substances.

Gold salt injection can sometimes be use to treat rheumatoid arthritis.

Again, not every patient will respond the same to these treatments. Not all people to medications in the same way. Your orthopaedic surgeon can provide a specific regiment of drug treatments.

Surgical Options

Surgery on your arthritic knee should be a last-resort optionafter youve exhausted all other options. Here are a few surgical treatments:

Arthroscopic surgery uses fiber optics so the surgeon can see inside the joint and clean any debris or restore damage cartilage.

An osteotomy cuts the thigh or shin bone to improve the alignment of the knee joint.

Knee arthroplastywhether total or partialreplaces the knee joint cartilage with metal and plastic.

Cartilage grafting is possible for knees where limited cartilage loss from trauma or arthritis.

Platelet-Rich Plasma Option

A PRP study published in late 2009 from the Rizzoli Orthopedic Institute in Bologna, Italy, found platelet-rich plasma (PRP) injected in knees with degenerative arthritis can improve knee function.

The results showed consistent improvement up to 6 months after PRP therapy, which makes it a promising, nonsurgical treatment. But PRP therapy is not a sportsmedicine silver bullet. There can be side effects, and some significant side effects. Herearethemostcommon.

To learn more about PRP treatments for your arthritic knee giveusacall or visit our office in St. Louis. We look forward to hearing from you.

Gene Therapy: Chinese Researching Gene Replacement

By adminSeptember 25, 2015Gene Therapy Clinics

When I mention the words gene therapy, you might immediately think of the horrifying eugenics experiments conducted by the Nazis in World War II.

Since then, however, fantastic advances in technology have allowed scientists to learn an incredible amount about how the human body works. As a result, gene therapy and genetic medicine have become a huge boon to mankind since the practice originally emerged.

Indeed, initiatives like the Human Genome Project have shed more light on genetic expression and how various traits and diseases are passed from generation to generation.

In fact, gene therapy currently in its infancy holds the promise of suppressing (or even curing) any number of genetic diseases or disorders.

And in this regard, scientists in China have just taken a bold new step forward. One that others have feared to take

Along with the very first thought about gene therapy came a huge concern: The very same therapies that could modify human genes in existing patients could be used to modify people before they were even born.

You see, when gene therapy is conducted on fully formed, living people, the results arent heritable. So if something goes wrong, its limited to that person any man-made genetic mistake wouldnt spread into the wider population.

But a genetically modified embryo could theoretically carry the new genetic information through every cell it ever grew including reproductive cells and pass the modification on to his or her children.

This fear, not to mention the specter of less ethical gene modifications in the future, has previously blocked scientists from performing gene replacement experiments on human embryos.

But not anymore

Scientists at Sun Yat-sen University in Guangzhou, China recently took an unprecedented step.

They replaced the genes in a single-cell embryo.

Their motives were well-intentioned the experiment was to try to replace a gene that causes a serious and sometimes fatal blood disorder, and which replicated similar gene replacement therapies tested on adult human cells and animal embryos.

They also took some precautions to allay ethical concerns. Lead scientist, Junjiu Huang, insisted on using non-viable embryos i.e., castoffs from fertility clinics that could never become fully developed humans.

Nevertheless, some scientists are up in arms about the experiment, despite the precautions taken. And despite the significance of the research, it caused enough controversy that the resulting report was said to have been rejected by some larger scientific journals.

Unfortunately, the experiment didnt produce the expected results anyway. The existing gene-replacement regimen didnt result in successful gene replacement often enough to justify any further experimentation along the same line.

But still, the step has been taken and its an important one

Ultimately, were nearing a day when it will be possible to cure diseases and disorders before people get them even before theyre born! Thats obviously a goal worth pursuing. And while some scientists dislike gene experimentation, others are more philosophical, reasoning that its only a matter of time before such trials are commonplace.

But were not there yet.

Gene replacement therapy is still a young science, and despite hundreds of therapies that have gone to human clinical trials, there isnt a single gene replacement therapy in widespread use.

Indeed, one of the more successful gene replacement treatments was actually stopped. Scientists found that while it did cure the disease it targeted, the new genetic code also seemed to cause leukemia.

Thats a prime example of how complex this field is and the danger of using such therapy on embryos. An unintended disease or disorder could be passed down from parent to child but perhaps not becoming apparent for many generations and long after that code is widespread.

However, with the experiment at Sun Yat-sen University having been completed, its clear that we no longer have the luxury of deferring the argument about the ethics of genetic changes to human embryos to some point in the future. Because the future has just occurred.

To living and investing in the future,

Greg Miller

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Gene Therapy: Chinese Researching Gene Replacement

Adult Stem Cell Banks and Clinics Marketing Stem Cell …

By adminSeptember 25, 2015Stem Cell Clinics

How many clinics in Texas market stem cell procedures? What interventions do they promote? How many adult stem cell banks are located in Texas? How do they advertise their services?

There does not appear to be a comprehensive record of stem cell banks and clinics marketing stem cell procedures within the state of Texas. I am therefore trying to determine how many stem cell banks and clinics marketing stem cells in Texas can be found using an approach that a patient or customer might take when searching the Internet. In an effort to locate such businesses, I used Google search engine and entered such terms as stem cells Texas, stem cell clinics Texas, cosmetic surgery stem cell Texas, orthopedic surgery stem cell clinic Texas, and anti-aging stem cells Texas. In total, I found twenty businesses marketing what they describe as stem cell procedures as well as three stem cell banks. During my search I also noticed and recorded a spa marketing plant stem cells and a dentist who advertises dental stem cell storage. Most facilities market what they describe as adult stem cell procedures. However, I found one clinic advertising stem cells taken from amniotic fluid and another facility promoting bovine stem cells to prospective customers. While Im skeptical that Ive managed to find all such businesses, the list below documents at least some of the businesses currently banking adult stem cells or promoting stem cell procedures in Texas. If you are familiar with additional banks and clinics or identify any errors in my list please feel welcome to leave a comment and help me revise this list.

Finally, please note that this list is provided to assist with the process of identifying and tracking stem cell banks in Texas as well as businesses marketing stem cells. I am not recommending or promoting any of these businesses. See FDA Warns About Stem Cell Claims for an important public safety message concerning marketing of stem cell procedures.

CLINICS MARKETING STEM CELL PROCEDURES

1. Advanced Skin Fitness

Location: Dallas-Fort Worth

Summary: markets iRevival and Vampire Facelift procedures intended to promote stem cell rejuvenation

Excerpt: Stem Cell Treatments: iRevival, Vampire Facelift. What if you could experience an utterly transformative change to your facial appearance in just a single skin rejuvenation treatmentwithout surgery or general anesthesia? Its now possible in a revolutionary procedure exclusive to patients of Advanced Skin Fitness located in Dallas, Texas. Created by Clinical Director William A. Moore, the treatment utilizes a combination of proven technologies of fractional laser resurfacing and stem cell technology to create unprecedented results in a fraction of the time of other techniques.

2. Advanced Surgical Arts

Location: Plano

Summary: markets Vampire Facelift that includes unipotent stem cells for skin rejuvenation

Excerpt: The Vampire Facelift combines the science of hyalurnonic acid (HA) fillers for volume replacement with unipotent stem cells for skin rejuvenation to provide a custom designer procedure. The stem cells used in the procedure, which are from Platelet Rich Plasma (PRP), only require a blood draw similar to a basic lab test. The HA fillers provide an increase in volume and sculpt the face, while the PRP works to rejuvenate the surface of the skin. The reason this minimally invasive procedure is so revolutionary is because the PRP contains eight growth factors that work over an extended period of time to stimulate new collagen growth from within.

3. Arilile Cosmetics Weight Loss & Body Sculpting

Location: DeSoto

Summary: markets various adult stem cell interventions

Excerpt: Aralile Stem Cell Institute & Research Center Specializing in Research and Training for Stem Cell Treatment for various Medical Conditions. Adult Stem Cells are repair cells of the body found mainly in the fat stores of the body. There are 80 million stems cells in a childs body. This amount is reduced to 35 million stem cells in circulation by age 40. Stem cell therapy increases these numbers adding millions of stem cells back into the bodys circulation. This serves to benefit various medical conditions such as; Diabetes, Rheumatoid Arthritis, Alzheimers Disease, Body Rejuvenation, Joint Pains, Parkinsons Disease, CVA (Stroke), Hypertension, Systemic Lupus, Anti Aging Benefits. Physician Testimony on Adult Stem cell therapy: I am Doctor Benedict Olusola, a 2004 gold and bronze medalist at the World Health Games and Masters Triple Jump champion. Three (3) years ago in Boston, at the master indoor championship I ruptured my knee cap ligament resulting in knee surgery. Eight months ago I received Stem Cell Therapy, using my own stem cells,now I am jumping again, more energetic, my vision has improvedand so has my golf game, producing more 300 yard drives and am on my way to winning more medals. Stem cell therapy has been shown to alleviate the symptomsin a number of medical conditions, including arthritis, diabetes with anti-aging benefits. Call for a free consultation today and find out what stem cell therapy can do for you. This procedure is not FDA approved and results and outcomes may vary. Please visit our website aralilecosmetics.com to learn more.

4. Austin Aesthetics

Location: Austin

Summary: markets skin stem cells obtained from bovine amniotic fluid

Excerpt: I first introduced Stem Cell therapy for the skin in 2000 in my aesthetic center in Austin, Texas. I used the products exclusively for approximately two years. The use of this therapy clearly took 20 years off the looks of my skin. Due to various political reasons and FDA involvement, this therapy was not available for several years so I was unable to continue to offer it to my clients or to continue its use for me and my family. The good news is that since then, science has progressed rapidly and we have recently been given the opportunity to offer to our clients the newer technology available today. The new and advanced CryoStem Cell Therapy provides serums that encompass every element and constituent of skin including collagen, hyaluronic acid (a component of collagen), elastin, DNA, RNA(i), fibroblasts, lipids, and embryonic stem cells. Because of the science of stem cells, your existing skin will replicate the condition of the applied new cells so that your new skin should be as flawless as when you were younger. This biological reprogramming creates the perfect environment for future generations of fresh, younger skin. The skin looks younger because, technically, it is younger. The CryoStem Skin Therapy System consists of 100% organic, chemical and preservative free ingredients and formulations. Stem cells are from a bovine source. DNA CryoStem technology is approved and registered by the United States Food & Drug Administration (FDA). The skin stem cells are obtained from bovine (cow) amniotic fluid. A special herd of bovines are raised under pristine and controlled conditions in France. These free-range bovines are organically fed, nurtured, and no vaccines or hormones are administered to ensure the highest standards of health and care. An innovative and proprietary collection process is utilized to extract the amniotic fluid under absolute sterile conditions and strict European governmental supervision. The extractions are carefully timed in order to achieve maximum amounts of stem cells, which have not become specific to the bovine genetic composition but contain the DNA information to convert to human genetic composition, specifically that of human skin. Science already knows that animal cultivated organs, such as pig heart valves, have made medical history and miracles while co-existing with the human body once implanted. This compatibility also applies to human skin. The cells are cryogenically (frozen) preserved. Keeping cells at freezing temperature permits them to hibernate and retain their energetic life-force and therapeutic value. This process allows the stem cells to stay fresh and active. Once the final product is created, the stem cells are frozen in individual ampoules for shipment, and the ampoule is kept frozen until the time of application/treatment. Extensive clinical studies and test have been conducted on the DNA CryoStem Skin Therapy System, and it meets the strictest consumer safety standards. It has been proven that a young cell coming into contact with an old cell leads to the reprogramming of the old cell. This reprogramming is made possible because of a cells power to share genetic information via DNA (deoxyribonucleic acid). When the skin stem cells come into contact (topically) with living human skin, the reintroduction of young, strong and powerful DNA begins to reorganize and share its biologically flawless information with existing aged and/or damaged cells. By means of this sharing of information, the future generations of skin will regenerate much stronger and younger looking. The skin stem cells, with correct DNA information, are in a cellular serum rich in vitamins, minerals, essential fats, enzymes, and natural antioxidants. These substances immediately start interacting with the skin, thus repairing free radical damage and creating moisture reserves, protein synthesis-promoting collagen, and elastin, as well as, performing other beneficial actions. The results are virtually immediate. You will see a change in the skin after the first session. Only a licensed skin care professional who has been approved and trained by the DNA Health Institue, Cryogenic Division, Certified DNA Practitioner (C.D.P.) can administer the CryoStem treatment. (We have four certified practitioners at Austin Aesthetics.)

5. Center for Spine Care

Location: Dallas

Summary: markets mesenchymal stem cell procedures for individuals with back and/or neck pain

Excerpt: CSC IS FIRST IN DALLAS TO LAUNCHREVOLUTIONARY STEM CELL THERAPY TO PROMOTE NATURAL HEALING FOR BACK PAIN. A ground-breaking new treatment utilizing mesenchymal stem cells to treat patients with neck and back pain caused from degenerative disc disease, is being used at the Center for Spine Care in Dallas. Mesenchymal stem cells are harvested from the patients hip bone, processed and then injected into the painful tissue during the same procedure. These particular cells have regenerative properties, helping to promote natural healing within the damaged disc or joint. There is no surgical exposure, damage to normal tissues or loss of motion in the spine. Spine surgeon & clinical researcher John Peloza, M.D., Medical Director of the Center for Spine Care, and the first in Dallas to utilize the treatment, is seeing great promise with pain relief for patients with degenerative disc disease. A pioneer in modern spine treatments, Dr. Peloza has been using mesenchymal stem cell therapy for years to promote bone growth in patients undergoing minimally invasive spine stabilization. This new technique has the potential to heal damaged or degenerative discs and joints with a biologic solution rather than major surgery. Stem cell therapy can be performed safely in an ambulatory surgery center under conscious sedation in most cases, in about 30 minutes. Patients who are now considered fusion or disc replacement candidates may be treated effectively with this new technology. Dr. Peloza states the preliminary data is impressive which is generating significant interest. As we study this technology and gain further understanding, we hope to expand the indications in order to treat more spinal conditions. Dr. Peloza cautions that while the procedure may be described as simple, only highly-trained spine surgeons should be performing it. This is modern scientific spine technology, and only board certified, fellowship trained spine surgeons who understand the science of stem cells, know the indications and contra-indications of the technology, and know how to treat potential complications should be performing stem cell therapy on the spine. It is important to know where stem cells fit in the continuum of care in spine treatments. This requires physicians who carefully research their outcomes with evidence based medicine.

6. CHARM (Center for Healing and Regenerative Medicine)

Location: Austin

Summary: markets mesenchymal stem cells for patients with musculoskeletal injuries

Excerpt: Our mission at the Center for Healing and Regenerative Medicine (CHARM) is to provide comprehensive, integrated therapeutic techniques to promote tissue regeneration and repair for individuals with musculoskeletal injuries and conditions. Mesenchymal Stem Cells (MSCs) are derived from the patients own fat tissue and bone marrow. Techniques are being studied to take advantage of the powerful repair that stem cells can produce. The use of the patients own tissues eliminates the issues of allergic reaction, genetic tissue interchange, rejection of tissue transplantation, and unintended or unknown infectious agents that would be a potential risk using tissue derived from another person. The ethical consequences of using embryonic fetal cell tissues are also completely avoided. Stem cells may be harvested from both bone marrow and adipose tissue, combined with Platelet-Rich Plasma, injected within and around the joint to produce a potentially more powerful strategy for growth and repair of complex injuries.

7. Dr. Henry Mentz

Location: Houston (Galleria/River Oaks, Memorial & Surgery Center)

Summary: markets stem cell-rich fat grafting

Excerpt: Dr. Mentz uses stem cellenriched fat grafting to restore the fullness and soft contours that characterize a younger face. The procedure achieves the following appearance goals: Restores volume to flattened cheeks and other sunken or thin areas of the face; Greatly diminishes wrinkles and folds such as the nasolabial folds that stretch from the bottom of the nose to the corners of the mouth, and the marionette lines that run downwards from the corners of the mouth; Enhances the shape and fullness of the lips. In addition, fat grafting can be used to rejuvenate and improve the look of other areas of the body. Like the face, the hands reflect some of the most visible signs of aging due to sun exposure and a loss of fat. Fat grafting can be used to restore a youthful look to hands by diminishing the prominence of bones, tendons, and veins. In body contouring, Dr. Mentz utilizes fat grafts to improve the shape of the buttocks and calves. The Benefits of Stem Cell-Enriched Fat Grafting: May rejuvenate the skins tone and texture; Produces a natural look; Potentially long-lasting; Minimal risk of allergic reaction because fat comes from a patients own body. Though fat grafting has been a part of plastic surgery for decades, the innovative use of stem-cells to enrich the grafts holds the potential to revolutionize this procedure. Dr. Mentz has been actively working with the nations leading stem cell researchers to mobilize the powerful characteristics of stem cells to increase the facial rejuvenation benefits of fat grafting. Stem cells have the unique ability to regenerate themselves and to repair damaged tissues in the body. Because of this characteristic, the cells may also have the power to rejuvenate the skins tone and texture. Though these benefits have not been proven, stem cells do enhance the survival rate of fat, which can be long-lasting.

8. East Texas Institute for Executive Health

Location: Tyler

Summary: markets adipose derived orthopedic stem cell procedures and stem cell facelift

Excerpt: Adipose Derived Orthopedic Stem Cell. Most people have heard about stem cells. Those are cells in your body that can grow into any other cell that your body needs. Most people think that only babies have them but in the last 4 years they have discovered that we all have a plentiful supply of these types of cells in the fat of our bodies. We have now learned how to harvest those cells from your fat, activate them and then put them back in your knees, hips, and shoulders to help repair cartilage and ligaments. Its done as an out patient procedure; It is not covered by insurance; Not everyone is a candidate. So call Executive Health to come in for a free consultation to see if you are one of the lucky people that this might help. We already have people who are walking around with no pain. By the way, you ladies, we also have a stem cell face lift that can make your face look about 20 years younger.

9. Escobedo Esthetics

Location: Austin

Summary: markets stem cell facelift

Excerpt: The PRP-BMAStem Cell Facelift exclusively at Escobedo Esthetics may sound like a mouthful it is a simple and natural procedure that uses 3 types of extracted stem cells from the bone marrow and platelet rich plasma from the blood to naturally stimulate tissue and collagen growth in key areas where aging is found in the skin. The term PRP stands for platelet rich plasma, a common healing component found in our blood. BMA signigies (sic) bone marrow aspirate, which includes all 3 bone marrow stem cells: mesenchymal, hematopoetic, and endothelial variations. The unique combination of BMA stem cells and plasma create an ultra enriched healing formula which works to stimulate faster tissue, collagen, and blood vessel growth. Patients undergoing this treatment can expect smoother, thicker, and healthier skin appearance and even texture with continuously improving results for up to two years. Synthetic dermal fillers are not for everyone. I truly recommend the PRP-BMA Stem Cell Facelift for those looking for a natural, permanent solution to regaining their youth. One hour with stem cell and plasma therapy can reverse over 10 years or more of aging in just a few months.- Dr. Michael Escobedo. Further, I cannot explain the dramatic changes the skin undergoes to correct that the severe damage done to skin as a result of aging. Mesenchymal and hematopoetic stem cells derived from bone marrow and plasma have also recently been used as a breakthrough treatment for people suffering from arthritis and sports related injuries. Stem cells are a key factor in natural healing in that stem cells will replicate into the cells of which they are injected. By injecting them into aging skin, the stem cells replicated into new, healthy skin cells which give the appearance to a younger look in the patient.

10. Foot and Ankle Associates of North Texas

Location: Grapevine

Summary: markets stem cell procedures for foot and ankle injuries. Stem cells are obtained from amniotic fluid retrieved from mothers undergoing C-sections.

Excerpt: Stem cell research reaches your feet in a new product called AmnioMatrix. For a very long time, I have been watching the stem cell research and debates and patiently (not really) waiting for a useful application in the foot and ankle. My blog today is to tell you about the patients I have used it on and their success. I began to use it in my practice last December with skeptical ideas on how successful it could be. Ive been pleasantly surprised at the results. Lets start with what the stem cells are. I use AmnioMatrix. This is amniotic fluid taken from mothers who have consented to have the fluid removed during C-sections. There is absolutely no harm to mom or baby and this is not done prior to birth. The fluid is then cryopreserved with no additives keeping the cells live for use when they are thawed and injected. So why these cells? Their job in the baby making process is to protect the fetus and help with development. When you hear the term my water broke, thats amniotic fluid. When placed in an adult to the site of an injury or chronic pain area, these cells recognize what is missing or not normal and begin a healing process. If you want to read more of about this, Applied Biologics will answer a lot of questions. So lets talk about some patients that have benefitted from this product.

11. Foot Specialists of Cedar Park and Georgetown

Location: Cedar Park and Georgetown

Summary: markets adult stem cell procedures for foot and ankle

Excerpt: Celling Technologies Res-Q system promotes the regeneration of tissue in foot and ankle procedures by delivering a highly concentrated volume of your own adult stem cells. The cells are obtained through a painless technique, which is part of the procedure, and can be completed within minutes. Your own stem cells are then concentrated through a patented process and delivered back to the injured site to facilitate in the bodys natural healing process. Over the last decade there has been an explosion of studies examining the use of adult stem cells to treat a variety of orthopedic conditions ranging from soft tissue loss and cartilage defects to bone loss due to trauma or tumor removal. Clinical data has demonstrated the ability of adult stem cells to treat long bone fractures that failed to heal, known as non-unions. Although these types of fractures have failed to respond to other treatments, an injection of stem cells has resulted in new bone formation and fracture healing. Soft tissue repair, especially at the ligament or tendon reattachment to bone can also lead to incomplete or compromised healing. Adult stem cells have been shown to promote the healing of soft tissues such as the Achilles tendon, the rotator cuff ligaments of the shoulder and the meniscus of the knee. Stem cells have far reaching and promising applications in the orthopedic and podiatric field. Researchers and clinicians believe the early introduction of stem cells to an injury could result in the prevention of major surgery such as total joint replacement. By infusing the injured or damaged tissue with undifferentiated stem cells from your own body, your podiatrist will be rejuvenating the cell population at the site of injection. This combined with the right physical therapy will lead to a full repair and regeneration of the tissue giving it back its proper function.

12. Forest Park Medical Center (Dr. Rob D. Dickerman)

Location: Plano and McKiney

Summary: autologous stem cells used in spinal fusions

Excerpt: Now, with technology, we can pull the bone marrow directly from the hip, concentrate it to get more stem cells, put it inside of a cage to hold it, then it does its job. Its like a cinder block that you build houses on, and you pack concrete inside the cinder block. Were packing stem cells inside this cage and then it grows from bone to bone through the cage.

13. Houston Orthopedic & Spine Hospital (Dr. Chris Meyer)

Previously called Foundation Surgical Hospital

Location: Bellaire

Summary: adult stem cells used in orthopedic procedures

Excerpt: Spine surgeon, Dr. Chris Meyer with Houston Orthopedic & Spine Hospital has established himself as a leader of utilizing adult stem cell therapy to regenerate tissue. He has extensive experience in harvesting adult stem cells during a routine spinal procedure and delivering those cells to his patients to aid in the treatment of severe back pain. During the procedure, bone marrow is aspirated from the iliac crest (pelvis), and then processed in a cell concentration system. The system, from Austin-based biotech company, Celling Technologies, concentrates bone marrow allowing the desired cells to be delivered back to the patient. The surgeon is then able to deliver wound-healing cells directly back to the injured site. These cells will release growth factors, immune responses and have the potential to develop into new bone forming cells as well as stimulate other cells to participate in the healing process.

14. MedSpa21

Location: Houston

Summary: markets stem cell enhanced cosmetic surgery and stem cell storage

Excerpt: Dr. Marino also has added stem cell therapy to all invasive procedures using PRP or platelet rich plasma.PRP aids in healing and helps to reduce scarring and helps to increase cell turnover. Dr. Marinos Stem Cell Enhanced Facial Volume Restoration, uses a patients fat tissue and her own blood, which are rich sources of stem cells and regenerative cells, to provide women the option of restoring a more youthful facial appearance without the use of synthetic implants. Volume loss in the face is a normal part of aging and adding your own fat with your own stem cells can help turn back the hands of time. Dr. Marino is pleased to be the first surgeon in Houston to offer stem cell storage through CRYO-LIP. You can find out detailed information on their website. With as little as 25 ccs of your fat, CRYO-LIP can harvest your stem cells and differentiate them to make just what your body needs later in life and no matter how old you are, the stem cells stay at the age you were when they were collected. Stem cell research has exploded over the past 20 years and stem cells with or without fat have been used successfully in the treatment of osteoarthritis (regenerates cartilage), after major heart attacks (regenerates heart muscle), diabetes Type I (regenerates insulin producing cells), Parkinsons Disease (regenerates substantiaNigra in the brain), urinary incontinence (injected with fat to support the urethra and anterior vaginal wall), sexual enhancement (injected vaginally to enhance G-spot and to reduce vaginal wall laxity without major reconstructive surgery and injected into the male penis to enhance penile length and diameter), and studies are ongoing for treatment of brain injury, both in adults and newborns. Cryo-Lip is a well established bank that provides viability studies on all fat specimens received both on initial processing and again after freezing. Their method of freezing the cells has produced one of the highest rates of viability upon thawing. The stem cells and fat that are frozen can be used for cosmetic augmentation or by other physician specialties, including interventional cardiologists and orthopedic surgeons, as well as physical medicine and rehabilitation specialists. Cryo-Lip stores fat in 25cc, 50cc, and up to 300cc aliquots with a nominal yearly storage fee. Life is unpredictable and this particular investment insures that your own stem cells are available for you at any time during your life on earth.

15. Neurosurgical Associates of San Antonio

Location: San Antonio

Summary: stem cells used in spinal fusions

Excerpt: For the first time stem cells are being used to aid in spinal fusion. This new technology is now available in San Antonio only at Methodist Hospital. Dr. Robert Johnson, a San Antonio orthopedic spinal surgeon was one of the first physicians in Texas (the U.S.?) to use the new technology. Using a newly developed needle, bone marrow is extracted from the pelvic or hip areas of the patient. Then the bone marrow is placed into a centrifuge that separates the stem cells and concentrates them from five to seven times their normal strength. Approximately eight to ten cc of liquid stem cells are produced. The stem cells are packed around the bone graft and the spinal column to promote fusion.

16. Neurosurgical Associates of Texarkana

Location: Texarkana

Summary: adult stem cells used in spine surgeries

Excerpt: A new breakthrough in adult stem cell technology has three Texarkana neurosurgeons leading their industry by utilizing concentrated stem cells for spine surgery. Dr. Lee Buono, Dr. Freddie Contreras, and Dr. J. Brette Dietze of Texarkana Neurological Associates are using the new procedure that harnesses the healing potential of adult stem cells from a patients own body. During surgeries for the neck and back, bone marrow is extracted from the hip through a small incision. The marrow is processed by an FDA-approved device and the living cells are delivered back to the surgeon in a concentrated dose to be implanted back into a patient to promote healing. This procedure is on the cutting edge of regenerative spine surgeries; it is a resource that must be considered as a standard for healing, Dr. Buono said. Dr. Dietze adds, Biological graft materials have become a standard accessory in neurosurgery autologous iliac crest autograft being the gold standard. Autologous bone graft is likely traumatic and time-consuming. My personal commitment to my patients to offer the most current advancements and treatment options is also an expectation held unanimous by Texarkana Neurological Associates. This surgical approach is without arguments on the cutting edge; the potential outcomes utilizing this technology may create an option for even the most critical patient. This is minimally invasive, efficient, safe and effective. The concentrations of endothelial progenitor cells, hematopoietic stem cells, and mesenchymal stem cells have adhesion properties that ensure the cells remain localized where we need them to promote tissue growth and healing.. As a neurosurgeon, I pride myself on the ability to offer my patient the most current, and proven, procedures. I am utilizing BMAC(R) from Harvest Technologies, which is truly on the cutting edge of medical technology, highly credible research from respected surgeons and top-tier institutions support its potential advantage to aid in faster healing time and favorable postoperative outcomes. BMAC(R) provides an efficacious, minimally invasive system to utilize a patients autologous bone marrow, which science has shown to contain high numbers of adult stem cells. By concentrating these cells safely, and quickly, I can measurably increase the potential to possibly achieve exceptional outcomes. I have always committed to provide a level of skill, knowledge and care to compete with anyone in the country; I believe this product could greatly improve a patients own natural healing potential, and positively impact their quality of life, said Dr. Contreras. As the population ages, incidents of spinal degeneration will likely continue to increase. The potential of stem cells and regenerative medicine is virtually limitless for treatments of degenerative diseases since adult stem cells have the remarkable potential to differentiate and become new tissues such as bone, tendon, cartilage and heart muscle.

17. Pine Creek Medical Center

Location: Dallas

Summary: adult stem cells used in spinal surgeries

Excerpt: Spine surgeons at Pine Creek Medical Center in Dallas have established themselves as the leaders of a cutting-edge surgical procedure that utilizes a patients own adult stem cells to regenerate tissue. Doctors Douglas Won, Michael Rimlawi, and Francisco J. Battle, all spine surgeons, have extensive experience in harvesting adult stem cells during routine spinal procedures and delivering those cells back to their patients to aid in the treatment of severe back pain. The advancing technology in stem cell therapy is driving spine surgeons to look at different approaches to what has been considered the standard of care, says Won. The latest Fusionary procedure allows me to harvest the stem cells from the patient in a point of care process in the operating room during my routine spinal procedure. We not only deliver these tissue-forming adult stem cells back to the patient in a timely manner, but the pain of harvesting the cells is minimal.Adult stem cells have the remarkable potential to differentiate and become new tissue-forming cells in a variety of pathologies including bone, tendon, cartilage and heart muscle. The potential of stem cells in regenerative medicine is virtually limitless and is being studied for a host of treatments throughout the world today. In addition, the technology is now available to procure adult stem cells from bone marrow and adipose tissue without the challenging ethical issues that are often associated with embryonic stem cells. The medical community is now starting to take notice of the impact stem cells have on the future of medicine, says Rimlawi. Science has demonstrated the huge potential of stem cells in regenerative medicine and now the technologies are available to deliver these therapies to the patient. This breakthrough shows promising results and should ultimately lower costs. These therapies will become the standard of care in the future.

18. The Non-Surgical Center of Texas

Location: San Antonio

Summary: markets stem cell therapies

Excerpt: There are a wide variety of non-surgical interventions that may be prescribed for many conditions, either eliminating the need for surgery or significantly postponing it. Each treatment plan is individualized to address the needs of the patient. As an experienced Physiatrist, Dr. Zaharoff may recommend a combination of treatments. Treatment plans may include the use ofStem Cell Therapies.

19. United Neurology (Dr. Jamshid Lotfi)

Location: Houston

Summary: stem cells distributed to United Neurology by Celltex Therapeutics are injected and/or infused into individuals with multiple sclerosis and Parkinsons disease

Comment: United Neurology does not appear to overtly promote stem cell interventions. However, some individuals who have cells banked and processed by Celltex Therapeutics receive stem cell infusions and injections at United Neurology. Dr. Lotfi, one of two physicians associated with United Neurology, reports that he has administered stem cells expanded and banked by Celltex to patients with multiple sclerosis as well as individuals with Parkinsons disease.

20. Westlake Orthopaedics Spine and Sports (Dr. Scott Spann)

Location: Austin

Summary: adult stem cells used in orthopedic procedures

Excerpt: Dr. Scott Spann, board-certified orthopedic surgeon, autologous (adult) stem cell expert, former world-class athlete and recovered quadriplegic is an inspiring force and a living example of the transformative power of the human spirit. He is an innovator and leader in the worlds of minimally invasive spinal surgery and clinical stem cell use, as well as an advocate for the implementation of integrated healthcare. In the fall of 2005, a cycling accident left Dr. Spann a quadriplegic. During his recovery, Dr. Spann began to research stem cells. At the time their use was brand new in the world of clinical medicine and not readily available to patients in the United States. But the deeper and deeper he delved, the more impassioned Dr. Spann became about the potential benefits of utilizing autologous stem cells. This, he knew, would reshape the possible. Since then Dr. Spann has become a world leader in the clinical use of adult stem cells, performing surgeries and providing instruction and consultations around the globe.

ADULT STEM CELL BANKS

1. BioEdEN Tooth Cell Bank

Location: Austin, Texas (tooth stem cell bank with company headquartered in UK)

Summary: banks stem cells obtained from teeth

Excerpt: Pioneered by BioEDEN, tooth cell banking is a safe, natural and completely noninvasive method of collecting and preserving valuable stem cells which could hold the key to your childs health. There are no medical interventions required and no religious or ethical objections to overcome. The worlds first specialist tooth cell banking company, BioEDEN offers a simple, yet highly efficient method of collecting, isolating and storing these powerful baby tooth cells should they ever be heeded in the future. Tooth cell banking is a proactive decision being made by parents all over the world who recognize years of potential health benefits for their child in return for simply saving their baby teeth. You can not store these teeth yourself at home. BioEDEN has a patented process for the extraction of stem cells from teeth. This highly developed and validated process is specific for the isolation, assessment and storage of the cells themselves and is the product of several years of development work.

2. BioLife Cell Bank

Location: Dallas (stem cell bank with affiliated physicians in Texas and other U.S. states)

Summary: banks fat tissue and stem cells and makes banked stem cells available to network of physicians

Excerpt: BioLife Cell Bank offers a unique way to safely and affordably storefat (adipose tissue) and/orregenerative and stemcells. Until now, fat from liposuction has been thrown away as medical waste. But thanks to our breakthrough technology, these youthful cells are maintained over an entire lifetimefor use in: wound care,breastreconstruction andaugmentation, facelift, anti-aging and stem cell therapy,etc. Surgeons are utilizing fat as a natural filler (rather than synthetics such as Juvederm, Restalyne or Sculptra)forcosmetic and reconstructive procedures. Using fat from the patients own body (fat grafting or fat transfer) removes any risk of foreign materials being introducedprotecting patient safety. The fat banking and stem cell banking process is simple. Fat and the stem cells within it are acquired via liposuction,thenprocessed and stored using cryopreservation.If desired, adult stem cells maybe processedseparating the stem and regenerative cells for cryogenic preservation. The first and largest bank of its kind, BioLife features proprietary technologyoffering exclusivity and the most modern advances. Located in Dallas, Texas, BioLife serves patients throughout theUnited States and Canada with an extensive provider network. By creating your own repository of fat and/or stem cells, theyll be ready any time (whether in days or decades)to use in a variety of cosmetic procedures, therapeutic treatmentsor unanticipatedreconstructive surgeries.

3. Celltex Therapeutics

Location: Sugar Land

Summary: processes, expands, and banks stem cells obtained from adipose tissue and distributes stem cells to physicians who inject and/or infuse them into patients with multiple sclerosis, Parkinsons disease, and other illnesses

Excerpt: Celltex is focused on making it easy for individuals to bank their stem cells for potential future use. Much like banking your money for use in the future, banking your adult stem cells provides peace of mind should you need them quickly when you least expect it. Celltex is a leader in providing services for the rapidly expanding field of regenerative medicine. Specifically, Celltex precisely separates, multiplies and stores adult adipose-derived mesenchymal stem cells for autologous use by physicians. This means that an individuals fat (adipose) is the source of their adult stem cells, which are used only for that individual and never for any other person.

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Adult Stem Cell Banks and Clinics Marketing Stem Cell ...

Stem cell clinics, FDA, and giant, unapproved for-profit …

By adminSeptember 25, 2015Stem Cell Clinics

When I started blogging in 2010 the stem cell arena was a very different place.

Back then the hot topic was the battle over the legality of federal funding of embryonic stem cell research. That battle is over, or at least in hibernation, with a2013 federal court rulingallowing such funding to continue. The stem cell debate of today, which in its own way is just as fierce as the old one, is focused on how best to regulate the clinical translation and commercialization of innovative stem cell technologies.

The stakes in this new stem cell battle on the regulatory front are very high both for the stem cell field and for patients. Too little regulation could lead to harm to patients and damage to the stem cell field at a crucial juncture in its history, while too much regulation could stifle stem cell and regenerative medicine innovations.

The goal of stem cell advocates, including myself, is to find a regulatory sweet spot where science-based, innovative stem cell medicine can advance expeditiously. On the other side we have largely physicians and lawyers along with some patients arguing for drastically-reduced regulation and acceleration of for-profit stem cell interventions to patients, even without concrete data supporting safety or efficacy.

The latter group is a key part of a rapidly-proliferating stem cell clinic industry in the US. It consists of for-profit stem cell clinics that collectively have already conducted stem cell transplants on potentially thousands of patients without federal regulatory approval. These clinics have in effect thrown down the gauntlet to the US Food and Drug Administration (FDA) with their use of non-FDA approved stem cell products on patients.

The FDA is the regulatory body legally empowered to regulate biologic products and hence stem cells in the US. However, the clinics generally argue that they and their stem cell products should not be regulated by the FDA because they believe that the products are not drugs and they as the physicians transplanting the stem cells are just conducting the practice of medicine. FDA guidance over the years has consistently conflicted with this view and indicated to the contrary that these clinics are generally producing a stem cell product that is a biological drug. Even so the clinics at this time do not have FDA approval to make and use stem cell biological drugs. Such approval can come in response to what is called anInvestigational New Drug (IND)application. The clinics do not have IND approval from the FDA for their stem cell products or devices and do not have the licensing (called aBiological License Application or BLA) needed to produce and administer biological drug products such as certain types of stem cells. Collectively, for these reasons (absence of BLA and INDs),I definesuch clinics as unlicensed and their products as unapproved or unproven. Note that the physicians practicing at such clinics generally do have medical licenses from state medical boards, so they personally are licensed in that sense. These clinic physicians frequently further point out that doctors themselves can only be directly regulated by state medical boards and not by the FDA.

Where does the FDA get its authority to regulate stem cell products and clinics? TheFederal Food, Drug, and Cosmetic (FDC) Actand thePublic Health Service (PHS) Actgive the FDA the legal authority and responsibility to regulate biologics including human stem cells. Therefore, barring a federal court specifically overturning a particular FDA decision, FDA regulations are essentially law when it comes to clinical use of stem cells in the US. The FDA is given certain authority over stem cell biological products and procedures more specifically under several regulations including 21 CFR Part 1271.10, modified by 21 CFR 1271.15, which details exceptions to its regulatory requirements. A key term to know before trying to decipher the verbiage in these regulations is human cell and tissue products or HCT/Ps, which basically means human biological products including human stem cells.

Both individual doctors doing stem cell transplants and chains of dozens of stem cell clinics have sprouted up from coast to coast in the US in the last few years. These clinics, collectively numberingmore than 20 in the state of Texas aloneand more than 100 across America, are administering stem cell transplants of one kind or another to growing numbers of patients each year, potentially generating millions of dollars in income, all without FDA approval. In doing so many of these clinics, even absent litigation against the FDA, are operationally challenging and undermining the authority of the agency by acting as medical providers using stem cell products without FDA approval or licensing. They are also a direct challenge to science-based medicine more generally. To put it more bluntly, I believe these clinics are in essence collectively doing a huge, unapproved human experiment for profit.

The FDA has issued a steady stream of regulatory guidances, supported in some cases by court decisions (e.g.US v. Regenerative Sciences Inc.), painting a clear picture that stem cell clinics in a general sense (as well as their products, devices, and procedures) are within its regulatory domain and their products can be defined as biological drugs. Furthermore, in 2012 and 2013 the FDA took numerous actions related to stem cell clinics such as warning letters issued to a number of clinicsincluding the Texas stem cell clinic Celltex, which is well-known for having treatedGovernor Rick Perry.

Strangely the FDA tookno regulatory actionregarding stem cell clinics in 2014, at least none that is evident in the public domain, but the FDA did issue important new draft guidances related to stem cells (seehere,here, andhere) that I predict will be the basis for future action. One part of these guidances focuses on minimal manipulation, which is a key term in the stem cell clinical world and more broadly the world of biologics. If a biological product is defined as more than minimally manipulated it automatically leads that product to be defined as a biological drug subject to the full spectrum of drug regulatory oversight by the FDA. While stem cell clinics frequently argue that their products are less than minimally manipulated, it is becoming clearer that a large fraction of (but certainly not all) stem cell products sold by various clinics are likely to be viewed by the FDA as more than minimally manipulated.

The FDA and the stem cell therapy industry use numeric names for products that are minimally manipulated (361) or more than minimally manipulated (351), so these can be important to know as one navigates this arena. The for-profit stem cell clinics generally argue that their products are 361s, but I believe that FDA guidance indicates instead that a large number of these products are 351 biological drugs.

It is also valuable at this point to talk about the different kinds of stem cell treatments sold by dubious clinics. The most common stem cell product transplanted into patients is something calledstromal vascular fraction or SVF, which is a product manufactured from fat tissue. While various clinics use other stem cell products including cells isolated from bone marrow and other tissues (some of which may be 361s, while others are 351s), SVF is by far the most common stem cell product sold by clinics.

Amongst other things, the new draft FDA guidances explicitly single out SVF for attention and define it as a biological drug. This is particularly notable because many stem cell clinics have argued that SVF is not a drug and hence is not subject to drug-related FDA vetting. While many includingmyselfhave asserted in the past that SVF is almost certainly a drug and needs FDA approval before use, these new guidances from the FDA articulate, far more specifically and unambiguously than in the past, how SVF is by definition more than minimally manipulated and hence a drug (emphasis mine):

Example A-1: Adipose tissue is recovered by tumescent liposuction. The adipose tissue undergoes processing or manipulation (e.g., enzymatic digestion, mechanical disruption, etc.) to isolate cellular components, commonly referred to asstromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells for clinical therapeutic uses. This processing breaks down and eliminates the structural components that function to provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement.Therefore, based on the definition of minimal manipulation for structural tissue, this processing would generally be considered more than minimal manipulation.

Because of these new FDA guidances,I believethe fat stem cell clinic industry could be subject to future FDA action. However, the FDA is slow and cautious in how it proceeds with even what seem to be relatively straightforward regulatory actions that could even be viewed as neutral such as simply visiting a stem cell clinic to obtain information on its practices, products, devices, and such. It is important that the science-based medicine community advocate for appropriate, expeditious FDA action.

Another key term in the stem cell clinical arena is homologous use. When applied to an HCT/P product, it means that the clinical use of that product must be highly consistent with (i.e. homologous to) the properties of the original tissue from which the product was made; if it is not homologous, even if minimally manipulated it will automatically be considered a 351 drug product. An example of homologous use would be the transplant of hematopoietic stem cells to treat a hematopoietic disorder. In that case, a blood-related product is used to treat a blood-related disease.

An example of non-homologous use would be the transplant of SVF (again, a fat tissue derivative) as an intervention for a neurological disorder, as fat is not homologous to the nervous system. In this regard, it is important to point out that many stem cell clinics offer up their stem cell products (most often SVF) to treat a whole menu of human diseases manifesting in tissues that having nothing to do with fat or with the other tissues of origin of the various types of stem cells.

In an example given in the new draft FDA guidance in the section on homologous use, the agency points out that use of SVF to treat a bone or joint disease is non-homologous use (emphasis mine):

Example B-2: Adipose tissue is recovered and processed for use, as reflected by the labeling, advertising, or other indications of the manufacturers objective intent,to treat bone and joint disease. Because adipose tissue does not perform this function in the donor, using HCT/Ps from adipose tissue to treat bone and joint disease is generally considered a non-homologous use.

Another way that clinics try to get around having their products defined as biological drugs is througha possible FDA exceptioncalled same surgical procedure. The idea here is that if a procedure involving biologics such as stem cells is done in an autologous manner (the patient is both donor and recipient) and is completed in a single surgical procedure, then the biological product in theory might not be defined as a biological drug. It might be exempt from that designation because such procedures may have relatively lower risks. Many stem cell clinics have made the assertion that because in some cases they use stem cells in same surgical procedures that it means that they are not subject to FDA regulation of their product as a drug even if the product is, for example, SVF. However, the reality appears to be that the more than minimal manipulation and non-homologous use definitions trump the same surgical procedure exemption, discussed further inone of the 2014 draft FDA guidancesmentioned earlier. What this means is that if your product is more than minimally manipulated or it is used in a non-homologous manner (either of these is enough), it is still automatically defined as a biological drug even if you use it in a same-day surgical procedure.

The point of these FDA biologics regulations is to protect patients. It is logical that products that are more than minimally manipulated or used in a non-homologous manner pose higher risks to patients. As a result there is an appropriately higher requirement for evidence to support the use of such products in human patients. It is therefore of substantial concern that so many stem cell clinics in the US and around the world are going ahead and using experimental stem cell drugs as the basis of for-profit interventions without evidence that such products are safe or effective.

The stem cell entities in the US that concern me the most are chains of stem cell franchising clinics. These are rapidly-growing chains of affiliated clinics selling mostly fat stem cell-based interventions without FDA approval or licensing. Two examples of such chains are Cell Surgical Network and Stem.md.

Cell Surgical Network

Cell Surgical Network is a Beverly Hills-based chain of upwards of 50 stem cell clinics around the US that share philosophies, institutional review boards (IRB), procedures, devices, and malpractice insurance. They offer up SVF-based interventions for a wide range of medical conditions. I interviewed the leaders of Cell Surgical Network, Drs. Elliot Lander and Mark Berman, on my own blog last year (seehereandhere) and thenraised my concerns about their operations, including my view that their SVF product is likely more than minimally manipulated, that they use the product in what I view as a non-homologous manner, and that the device they use is not FDA-approved for this application. Their device is a column, which is a laboratory tool used to separate cells from the rest of the components of tissues, manufactured by a company called Medikan.

In response to my question regarding the possibility that the Cell Surgical Network SVF product is a 351 biological drug (and one for which they do not have FDA approval such as an IND to use it clinically), Cell Surgical Network responded in part by invoking the same-day surgical exemption, which again to my knowledge does not apply in this case with SVF:

We produce SVF (over 40 ingredients and cant be characterized) in a surgical procedure (cant be approved by the FDA theyve never approved a surgical procedure). If the FDA cant approve a surgical procedure, why would we possibly request them to approve this procedure?

It is worth noting that although arguably the FDA cannot directly regulate doctors or surgical procedures, the FDA can and does regulate drug products, biologics production procedures and devices in a general sense, which largely challenges the Cell Surgical Networks argument as well.

I also asked Cell Surgical Network about the issue of their arguably non-homologous use of SVF to treat diverse non-fat related conditions (see their menuhere). I found their response to be rather creative, but one with which I disagree:

We do have many conditions that we are looking at and in choosing them we have attempted to exploit either the regenerative, immuno-modulatory, or anti-inflammatory properties of SVF. Although SVF is used in all of our protocols, our deployment techniques vary considerably. I think the term homologous has been used rather loosely and in the field of regenerative medicine, a new paradigm defies simplistic categorizations of cell types. After all, what type of tissue is an undifferentiated progenitor cell? Can it be homologous? Isnt it potentially everything? For example, if it forms cartilage then could it have ever been anything other than a cartilage precursor? Our comfort zone is that we are surgeons performing a type of surgical tissue transfer procedure. There is no difference than when we replace a bladder with ileum or a coronary artery with a saphenous vein from an extremity. At the end of the day, the ability to use various tissues to treat human disease is within the realm of a surgeons domain.

In this line of argument then, would anything stem cell-related be considered pan-homologous to every other tissue and could never be used in a non-homologous manner? That seems like a rather radical notion and one not consistent with FDA guidance. Further, can a surgeon pretty much do anything they want? That seems to be a rather extreme idea too.

Still, despite these concerns, to my knowledge the FDA has so far never taken any action related to Cell Surgical Network. Therefore, a reasonable question to ask is why, if from my perspective the FDA would view Cell Surgical Network as likely being non-compliant in its use of stem cells, has the agency apparently done nothing about it? The frank answer is that no one except the FDA knows why or why not they take specific actions and they do publicly discuss specific situations.

Stem.md

Stem.mdis a similar group of stem cell clinics, but one that sprouted up on the East Coast. Stem.md has dozens of clinics too, including some using SVF as well as other types of stem cell products. While the Stem.md website frequently has changed over the years,as recently as a year agothey made some rather bold claims for their stem cell transplants including the remarkable statement that they provide a treatment for every condition. Sounds like a panacea, right? They also at one point claimed their advances were FDA-approved, although they took down that claim when I pointed it out to them as being incorrect. Like some other stem cell clinics, Stem.md has made a big deal out of treating pro athletes, including in their case former Yankee Bartolo Colon, which might remind you ofthe recent case wherestem cell clinics Stemedica and Novastem arguably could have benefited from a free stem cell intervention performed on hockey legend Gordie Howe as a public relations opportunity.

Some of the same nagging issues come up with Stem.md as with Cell Surgical Network, including potential non-homologous use and more-than-minimal manipulation. However, as with Cell Surgical Network, to my knowledge the FDA has not taken any regulatory action related to Stem.md.

While the recent FDA draft guidances are a step in the right direction of increased clarity, if the FDA takes no action, or waits years to enforce its finalized guidances, the end result is that the FDA is undermining its own authority and I believe putting patients at increased risk. In principle, in the absence of FDA action, stem cell clinics can effectively argue that if their practices did violate FDA regulations then the FDA should have done something about it by now. In the absence of regulatory action, there is always the possibility that the FDA could view the clinics use of stem cell products as compliant. I would also note that my views presented in this article, of course, do not necessarily reflect those of the FDA, and the stem cell clinics view FDA regulations quite differently.

A relatively newer, but important issue related to stem cell clinics is the listing of their stem cell interventions on the official US governments clinical trials website, ClinicalTrials.gov. I recentlyinterviewedthe Director of ClinicalTrials.gov, Dr. Deborah Zarin, to ask her about key issues including specific questions related to stem cell clinic listings. I was concerned to find out that ClinicalTrials.gov largely operates on the honor system in terms of deciding whether to list trials submitted to it for consideration. For example, there is neither specific vetting of US trials (keep in mind that ClinicalTrials.gov lists trials from all over the world) for FDA compliance nor a requirement that trials list specific IRB or other key information. Trials listed on the database can also be of a for-profit nature (i.e. patients are charged simply for participating in the trial before there is concrete evidence that the product or procedure in question is safe or effective) and based on the information in the trial listing, there is no straightforward way for patients to know that reality. I believe that this situation puts patients at added risk and also puts the valuable mission of ClinicalTrials.govin jeopardy.

The end result of this situation is that many for-profit stem cell clinics have trials listed on ClinicalTrials.gov and some use that listing as a marketing tool. What kind of money is involved here? Cell Surgical Network has a clinical trial listed with a projected enrollment of3,000 patientsand hypothetically if the organization makes $5,000 profit per patient that would add up to $15 million, again before the SVF product in question is even known to be safe or effective for the particular condition in question and without FDA approval or licensing.

I believe that a number of changes are needed at ClinicalTrials.gov including a requirement that for-profit trials be labeled clearly as such near the top of their listing page, that the listing of a given trial on the site should be prohibited from being used as a marketing tool by the entity responsible for the trial, and that the ClinicalTrial.gov team vet trials located in the US for FDA compliance and as needed consult with the FDA on this matter.

If you feel likewise, this is one case where you can easily take positive action during a specific window of time. ClinicalTrials.gov has issued a Notice of Proposed Rule Making (NPRM), detailed in a very recent open accessNew England Journal of Medicinearticleby Dr. Zarin. Comments on proposed changes including suggestions such as mine can be submitted in response tothis NRPM, but only until February 19th. I encourage you to submit comments and I have dug through the websites to find thisdirect linkthat allows you to do so quickly and easily.

The overall bottom line with most stem cell clinics in the US is that collectively they could be viewed as conducting a huge, unapproved and for-profit stem cell experiment of a sort, on thousands of vulnerable patients who are often desperately looking for hope. At the very least these patients are spending money that they can ill afford to lose on stem cell transplants that probably do not help them. It is also quite possible that some of these patients are being harmed. Stem cells do not always do what we might hope and their power to potentially help patients is equaled by their potential to do harm, especially when not backed up by rigorous science andphysician training. For example, fat stem cells are typically a heterogeneous mix of a variety of cell types with variable multipotency meaning that they can not only form mature fat tissue, but also potentially blood vessels, bone, cartilage, or others. The growth of an undesired tissue in the wrong place could be a major adverse outcome. There is evidence of potential for patient harm including growth ofbone in an eyeandnose tissue in a spinefrom stem cell treatments that went awry. Some patients treated at stem cell clinics have died, including inthe US,Germany, and elsewhere.

More broadly in this new stem cell debate, the for-profit clinic argument for stem cell deregulation and weakening of the FDAs role in regulating stem cell products is a direct challenge to our system of science-based medicine. Furthermore, while to those of us in the stem cell field it may often seem clear where we can place a dividing line between the dubious clinics and the ones who follow the rules, that line is at best fuzzy for the wider community (including patients). For this reason the ever-growing unapproved human stem cell experiment poses a grave risk to the legitimate stem cell field as well. Governmental entities such as the FDA and ClinicalTrials.gov perform important services in this arena, but can and should do better to reign in the wild west mentality of the stem cell clinic industry in America today. Advocates of science-based medicine have an opportunity to make a positive impact here as well via educational outreach, participation in the FDA guidance comment process, and advocacy for responsible clinical research.

Note: a version of this piece was first posted at Sciencebasedmedicine.org.

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Stem cell clinics, FDA, and giant, unapproved for-profit ...

Regenocyte are leading stem cell doctors in the USA.

By adminSeptember 25, 2015Stem Cell Doctors

2014 Stem Cell Pioneer Awards Stem Cell Awards Ceremony recognizing those pioneers in the field of Regenerative Therapy. Highlights of a few of the patients treated from 2006 to present. Treatments for heart, lung, neurologic and other diseases.

Why do patients choose us for their treatment? Especially those seeking serious outcomes? Why does Regenocyte have the most consistent, reproducible and best outcomes in the field of Regenerative Medicine? Click here to read more >>

If you are searching the web for stem cell doctors because you or a loved one suffer from severe heart, lung, or circulatory problems, it is possible that the latest therapies using adult stem cells can restore your quality of life to an unexpected level.

Because adult stem cell therapies are safe, simple, and minimally-invasive, they particularly help those who have exhausted the possibilities of other treatments.

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Regenocyte is a group of stem cell doctors leading the world in the therapeutic use of adult stem cell therapy. Headquartered on the Gulf Coast of Florida in Bonita Springs, Florida. Regenocyte is comprised of both US and international Physicians and staff with extensive training and experience in adult stem cell therapy.

Treatments using the patients own activated adult stem cells have been shown to restore a significant amount of normal function that had been written off as gone forever. With increases in function, patients recover their independence from medications, breathing devices and other kinds of medical apparatus. They may be freed from their dependence upon others.

Read more about the benefits of adult stem cell therapy.

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Regenocyte are leading stem cell doctors in the USA.

CD47 – Research and Clinical Trials – Institute for Stem …

By adminSeptember 25, 2015Stem Cell Medicine

The anti-CD47 cancer therapy clinical trials

The clinical trials of the anti-CD47 antibody are underway. As with most FDA phase-1 safety trials, the clinical trial is small and is not currently recruiting additional patients. As the trial progresses, information about the patients in the trial and the data about how the antibody is performing are kept confidential. In accordance with the clinical trial protocol and the policy of the Stanford School of Medicine, we wont be releasing information about the progress of the trial until the data is release by the clinical trials team at the conclusion of the study. Phase-1 clinical trials typically last about 18 months, although this particular trial may be shorter or longer than that.

If and when the clinical trial has openings for additional participants, an announcement will be made on this page. In the meantime, patients can search for currently open trials in the United States through the NIH Clinical Trials Database. Other clinical trials at Stanford can be found here.

CD47 is a kind of protein that is found on the surface of many cells in the body. It tells circulating immune cells called macrophages not to eat these cells. The body uses the CD47 protein to protect cells that should be protected and to help dispose of cells that are aged or diseased. For instance, red blood cells start off with a lot of CD47 on their cell surface when young but slowly lose CD47 as they age. At some point, the amount of CD47 on the surface of an aging red blood cells is not enough to stave off the macrophages, and those older cells are devoured and destroyed, making way for new red blood cells. In this way, the supply of fresh blood cells is constantly replenished.

Unfortunately, some cells that should be destroyed are not. Researchers at Stanford have discovered that nearly every kind of cancer cell has a large amount of CD47 on the cell surface. This protein signal protects the cancer against attack by the body's immune system. Stanford investigators have discovered if that they block the CD47 "don't-eat-me" signal through the use of anti-CD47 antibodies, macrophages will consume and destroy cancer cells. Deadly human cancers have been diminished or eliminated in animal models through the use of anti-CD47 antibody.

News:

Anti-CD47 antibody may offer new route to successful cancer vaccination

Engineered molecules boost immune attack on cancer

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CD47 - Research and Clinical Trials - Institute for Stem ...

Sickle Cell Anemia: Learn About SCD Symptoms and Treatment

By adminSeptember 25, 2015Uncategorized

Sickle cell anemia (SCD) facts

Sickle cell anemia (sickle cell disease) is a disorder of the blood caused by an inherited abnormal hemoglobin (the oxygen-carrying protein within the red blood cells). The abnormal hemoglobin causes distorted (sickled) red blood cells. The sickled red blood cells are fragile and prone to rupture. When the number of red blood cells decreases from rupture (hemolysis), anemia is the result. This condition is referred to as sickle cell anemia. The irregular sickled cells can also block blood vessels causing tissue and organ damage and pain.

Sickle cell anemia is one of the most common inherited blood anemias. The disease primarily affects Africans and African Americans. It is estimated that in the United States, some 90,000 to 100,000 Americans are afflicted with sickle cell anemia. Overall, current estimates are that one in 500 U.S. African American births is affected with sickle cell anemia.

Sickle cell anemia is inherited as an autosomal (meaning that the gene is not linked to a sex chromosome) recessive condition. This means that the gene can be passed on from a parent carrying it to male and female children. In order for sickle cell anemia to occur, a sickle cell gene must be inherited from both the mother and the father, so that the child has two sickle cell genes.

The inheritance of just one sickle gene is called sickle cell trait or the "carrier" state. Sickle cell trait does not cause sickle cell anemia. Persons with sickle cell trait usually do not have many symptoms of disease and have hospitalization rates and life expectancies identical to unaffected people. When two carriers of sickle cell trait mate, their offspring have a one in four chance of having sickle cell anemia. (In some parts of Africa, one in five persons is a carrier for sickle cell trait.)

Medically Reviewed by a Doctor on 5/21/2015

Sickle Cell Disease (Sickle Cell Anemia) - Experience Question: Please describe your experience with sickle cell disease (sickle cell anemia).

Sickle Cell Disease (Anemia) - Diagnosis Question: How was your sickle cell anemia diagnosed?

Sickle Cell Disease (Sickle Cell Anemia) - Symptoms Question: At what age did symptoms of sickle cell anemia first appear in someone you know? Please describe other symptoms.

Red blood cells are manufactured in the bone marrow. Their unique biconcave shape (think of squeezing a marshmallow between your fingers) increases their storage capacity for hemoglobin molecules that carry oxygen. They also make the cells pliable and soft so they can squeeze through the tiniest blood vessels in the body. In sickle disease, the red blood cells form an abnormal crescent shape that is rigid, causing the red blood cells to be damaged. The cells aren't malleable enough to get through tight spaces, and this can increase the risk of forming blood clots in the small capillaries of different organs causing the potential for organ damage.

Sickle Cell Disease (Sickle Cell Anemia … – MedicineNet

By adminSeptember 25, 2015Uncategorized

What are the symptoms and treatments of sickle cell anemia?

Virtually all of the major symptoms of sickle cell anemia are the direct result of the abnormally shaped, sickled red blood cells blocking the flow of blood that circulates through the tissues of the body. The tissues with impaired circulation suffer damage from lack of oxygen. Damage to tissues and organs of the body can cause severe disability in patients with sickle cell anemia. The patients endure episodes of intermittent "crises" of variable frequency and severity, depending on the degree of organ involvement.

The major features and symptoms of sickle cell anemia include:

Some features of sickle cell anemia, such as fatigue, anemia, pain crises, and bone infarcts can occur at any age. Many features typically occur in certain age groups.

Sickle cell anemia usually first presents in the first year of life. Infants and younger children can suffer with fever, abdominal pain, pneumococcal bacterial infections, painful swellings of the hands and feet (dactylitis), and splenic sequestration. Adolescents and young adults more commonly develop leg ulcers, aseptic necrosis, and eye damage. Symptoms in adult typically are intermittent pain episodes due to injury of bone, muscle, or internal organs.

Affected infants do not develop symptoms in the first few months of life because the hemoglobin produced by the developing fetus (fetal hemoglobin) protects the red blood cells from sickling. This fetal hemoglobin is absent in the red blood cells that are produced after birth so that by 5 months of age, the sickling of the red blood cells is prominent and symptoms begin.

The treatment of sickle cell anemia is directed to the individual features of the illness present. In general treatment is directed at the management and prevention of the acute manifestations as well as therapies directed toward blocking the red blood cells from stacking together. There is no single remedy to reverse the anemia. It is, therefore, important that affected individuals and their family members have an optimal understanding of the illness and that communication with the doctors and medical personnel be maintained.

Fatigue is a common symptom in persons with sickle cell anemia. Sickle cell anemia causes a chronic form of anemia which can lead to fatigue. The sickled red blood cells are prone to breakage (hemolysis) which causes reduced red blood cell life span (the normal life span of a red blood cell is 120 days). These sickled red blood cells are easily detected with a microscope examination of a smear of blood on a glass slide.

Typically, the site of red blood cell production (bone marrow) works overtime to produce these cells rapidly, attempting to compensate for their destruction in the circulation. Occasionally, the bone marrow suddenly stops producing the red blood cells which causes a very severe form of anemia (aplastic crises). Aplastic crises can be promoted by infections that otherwise would seem less significant, including viruses of the stomach and bowels and the flu (influenza).

The anemia of sickle cell anemia tends to stabilize without specific treatments. The degree of anemia is defined by measurement of the blood hemoglobin level. Hemoglobin is the protein molecule in red blood cells which carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues to the lungs. Blood hemoglobin levels in persons with sickle cell anemia are generally between 6 to 8 gms/dl (normal levels are above 11 gms/dl). Occasionally, there can be a severe drop in hemoglobin requiring a blood transfusion to correct the anemia (such as in patients suffering splenic sequestration). Blood transfusion is usually reserved for those patients with other complications, including pneumonia, lung infarction, stroke, severe leg ulceration, or late pregnancy. (Among the risks of blood transfusion are hepatitis, infection, immune reaction, and injury to body tissues from iron overload.) Transfusions are also given to patients to prepare them for surgical procedures. Folic acid is given as a supplement. Sometimes a red blood cell exchange is performed. This process removes some of the sickle blood cells and replaces them with normal (non-sickle) blood cells. It is done when the sickle cell crisis is so sever that other forms of treatment are not helping.

Pain crises in persons with sickle cell anemia are intermittent painful episodes that are the result of inadequate blood supply to body tissues. The impaired circulation is caused by the blockage of various blood vessels from the sickling of red blood cells. The sickled red blood cells slow or completely impede the normal flow of blood through the tissues. This leads to excruciating pain, often requiring hospitalization and opiate medication for relief. The pain typically is throbbing and can change its location from one body area to another. Bones are frequently affected. Pain in the abdomen with tenderness is common and can mimic appendicitis. Fever frequently is associated with the pain crises.

A pain crisis can be promoted by preceding dehydration, infection, injury, cold exposure, emotional stress, or strenuous exercise. As a prevention measure, persons with sickle cell anemia should avoid extremes of heat and cold.

Pain crises require analgesia for pain and increased fluid intake. Dehydration must be prevented to avoid further injury to the tissues and intravenous fluids can be necessary. Along with the fluids clotrimazole and magnesium are often given. Other modalities, such as biofeedback, self-hypnosis, and/or electrical nerve stimulation may be helpful.

Hydroxyurea is a medication that is currently being used in adults and children with severe pain from sickle cell anemia. It is also considered for those with recurrent strokes and frequent transfusions. This drug acts by increasing the amount of fetal hemoglobin in the blood (this form of hemoglobin is resistant to sickling of the red blood cells). The response to hydroxyurea is variable and unpredictable from patient to patient. Hydroxyurea can be suppressive to the bone marrow.

Swelling and inflammation of the hands and/or feet is often an early sign of sickle cell anemia. The swelling involves entire fingers and/or toes and is called dactylitis. Dactylitis is caused by injury to the bones of the affected digits by repeated episodes of inadequate blood circulation. Dactylitis generally occurs in children with sickle cell anemia from age 6 months to 8 years.

Joint inflammation (arthritis) with pain, swelling, tenderness, and limited range of motion can accompany the dactylitis. Sometimes, not only the joints of the hands or feet are affected, but also a knee or an elbow.

The inflammation from dactylitis and arthritis can be reduced by anti-inflammation medications, such as ibuprofen and aspirin.

Lung infection (pneumonia) is extremely common in children with sickle cell anemia and is also the most common reason for hospitalization. Pneumonia can be slow to respond to antibiotics. The type of bacteria that is frequently the cause of pneumonia is called the pneumococcus. (This is, in part, due to the increased susceptibility to this particular bacteria when the spleen is poorly functioning.) Vaccination against pneumococcal infection is generally recommended.

Children with sickle cell anemia are also at risk for infection of the brain and spinal fluid (meningitis). Bacteria that are frequent causes of this infection include the Pneumococcus and Haemophilus bacteria.

Furthermore, children with sickle cell anemia are at risk for an unusual form of bone infection (osteomyelitis). The infection is typically from a bacteria called Salmonella.

Bacterial infections can be serious and even overwhelming for patients with sickle cell anemia. Early detection and antibiotic treatment are the keys to minimizing complications. Any child with sickle cell anemia must be evaluated by medical professionals when fever or other signs of infection (such as unexplained pain or cough) appear.

Over time, the spleen can become damaged and stop working, which increases the risk of developing various severe infections.

It has been demonstrated that the liver, and especially the spleen, are organs that are very active in removing sickled red blood cells from the circulation of persons with sickle cell anemia. This process can accelerate suddenly. Sudden pooling of blood in the spleen is referred to as splenic sequestration.

Splenic sequestration can cause very severe anemia and even result in death.

The spleen is commonly enlarged (splenomegaly) in younger children with sickle cell anemia. As the spleen is repeatedly injured by damage from impaired blood supply, it gradually shrinks with scarring. Impairment of the normal function of the spleen increases the tendency to become infected with bacteria.

Sudden pooling of blood in the spleen (splenic sequestration) can result in a very severe anemia and death. These patients can develop shock and lose consciousness. Transfusion of blood and fluids can be critical if this occurs.

Liver enlargement (hepatomegaly) occurs as it becomes congested with red blood cells as well. The liver is often firm and can become tender. Impaired liver function can result in yellowing of the eyes (jaundice). The gallbladder, which drains bile from the liver, can fill with gallstones. Inflammation of the gallbladder (cholecystitis) can cause nausea and vomiting and require its removal.

Aside from lung infection (pneumonia), the lungs of children with sickle cell anemia can also be injured by inadequate circulation of blood which causes areas of tissue death. This lung damage can be difficult to distinguish from pneumonia and is known as acute chest syndrome. These localized areas of lung tissue damage are referred to as pulmonary infarcts. Pulmonary infarcts often require a special x-ray test using a dye injected into the affected areas (angiogram) for diagnosis. Repeated pulmonary infarcts can lead to scarring of the lungs of children with sickle cell anemia by the time they reach adolescence.

The heart is frequently enlarged in children with sickle cell anemia. Rapid heart rates and murmurs are common. The heart muscle can also be injured by infarcts and iron depositing in the muscle as it leaks from the ruptured red blood cells. Over time, the heart muscle weakens and the heart pumps blood more and more poorly.

Injuries to the lungs or heart are treated according to the specific type of damage and the degree of impairment of organ function. Supplementary oxygen can be required. Infections of the lungs require aggressive antibiotics. Transfusions can sometimes help prevent further damage to the lung tissue. Heart failure can require medications to assist the heart in more effectively pumping blood to the body.

The legs of patients with sickle cell anemia are susceptible to skin breakdown and ulceration. This seems to be a result of the stagnant blood flow caused by the sickled red blood cells. Injury to the skin of the legs or ankles can promote skin damage and ulceration.

Leg ulcers most commonly occur in adults and usually form over the ankles and sides of the lower legs. The ulcers can become severe, even encircling the leg, and are prone to infection.

Leg ulcers can become chronic and resistant to many treatments. Oral antibiotics and topical creams are often used. Elevation of the leg, careful dressing changes, and other topical therapies can be helpful. Some ulcers can be so resistant that skin grafting is recommended, though this may be compromised by impaired healing.

Inadequate circulation of the blood, which is characteristic of sickle cell anemia, also causes areas of death of bone tissue (bone infarction). Aseptic necrosis, or localized bone death, is a result of inadequate oxygen supply to the bone. Aseptic necrosis is also referred to as osteonecrosis.

While virtually any bone can be affected, the most common are the bones of the thighs, legs, and arms. The result can permanently damage or deform the hips, shoulders, or knees. Pain, tenderness, and disability frequently are signs of aseptic necrosis. Painful bone infarcts can be relieved by rest and pain medications.

Aseptic necrosis can permanently damage large joints (such as the hips or shoulders). Local pain can be relieved and worsening of the condition can be prevented by avoiding weight bearing. With more severe damage, total joint replacement may be needed to restore function.

The critical area of the eye that normally senses light is called the retina. The retina is in the back of the eye and is nourished by many tiny blood vessels. Impairment of the circulation from the sickling of red blood cells results in damage to the retina (retinopathy). The result can be partial or complete blindness.

Bleeding can also occur within the eye (retinal hemorrhage) and retinal detachment can result. Retinal detachment can lead to blindness.

Once blindness occurs, it is usually permanent. Preventative measures, such as laser treatments, can be used if bleeding into the eye and retinal detachment are detected early.

Additional features of sickle cell anemia include weakening of bones from osteoporosis, kidney damage and infection, and nervous system damage. Osteoporosis can lead to severe pain in the back and deformity from collapse of the spine (vertebrae). Kidney damage can lead to poor kidney function with a resulting imbalance of blood sodium and acidity as well as bleeding into the urine. Kidney infection can cause pelvic pain and require hospitalization with antibiotic treatment. Injury to the nervous system can result from meningitis or sickle cell anemia itself. Poor blood circulation in the brain can cause stroke, convulsions, and coma.

Damage to the brain from stroke can cause permanent loss of function to areas of the body. Transfusion of blood and fluids intravenously can be critical. Medications to reduce the chance of seizures are sometimes added. If stroke results in long-term impairment of function, physical therapy, speech therapy, and occupational therapy can be helpful.

Priapism, an abnormally persistent erection of the penis in the absence of sexual desire, can occur in persons with sickle cell anemia. Priapism can lead to impotence and damage to affected tissues.

Medically Reviewed by a Doctor on 5/21/2015

Sickle Cell Disease (Sickle Cell Anemia) - Experience Question: Please describe your experience with sickle cell disease (sickle cell anemia).

Sickle Cell Disease (Anemia) - Diagnosis Question: How was your sickle cell anemia diagnosed?

Sickle Cell Disease (Sickle Cell Anemia) - Symptoms Question: At what age did symptoms of sickle cell anemia first appear in someone you know? Please describe other symptoms.

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Sickle Cell Disease (Sickle Cell Anemia ... - MedicineNet

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Regenocyte are leading stem cell doctors in the USA.

CD47 – Research and Clinical Trials – Institute for Stem …

Sickle Cell Anemia: Learn About SCD Symptoms and Treatment

Sickle Cell Disease (Sickle Cell Anemia … – MedicineNet