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Stem Cell for Lower Back Pain Specialists Tombal TX | The Best Stem Cell Doctors in Tombal TX

Stem Cell for Lower Back Pain Specialists Tombal TX | The Best Stem Cell Doctors in Tombal TX CALL US: (281) 367-6900 http://painreliefandhealing.com

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Stem Cell Therapy Treatment

Stem Cell Therapy Tombal TX, Come in today feel better tonight! Pain is one of the many reasons a patient comes to the doctor. At the Institute Stem Cell Therapy Tombal TX,we are very serious about treating the cause of your pain. We know it is vital to relieve the pain as soon as possible. For this reason we see patients same day most of the time. Stem Cell Therapy Tombal TX, Physical medicine procedures, acupuncture or pain management services are rapidly engaged with the goal of relieving the pain while correcting the cause.

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Stem Cell for Lower Back Pain Specialists Tombal TX | The Best Stem Cell Doctors in Tombal TX

Regenerative Medicine Uses And Future Potential …

What Is Regenerative Medicine? If youre suffering from ongoing, nagging chronic pain that hasnt benefited from other treatments, you could benefit from an exciting new area of pain management known as regenerative medicine. These minimally-invasive treatments offer patients pain relief, while reducing the likelihood of infection and avoiding the need for surgery. For many patients, regenerative medicines can help them get their lives back by jump-starting their bodys own natural healing processes.

Regenerative medicine includes treatments like PRP therapy and stem cell therapy. The most common conditions that have been successfully treated using regenerative medical procedures include arthritis andinjuries to cartilage, tendons, muscle, bone, spinal discs, and other tissue types. For many patients, it can help them:

In this post, we talk about how these treatments work and if they could relieve your pain.

For these patients, regenerative medicine may be able to help. Regenerative medicines are cutting-edge therapies that use chemistry, medicine, robotics, biology, computer science, genetics, and engineering to construct a biologically compatible structure for many different tissues found in the body.Although relatively new in the field of acute and chronic pain management, regenerative medical procedures do date back as early as 1962.

Regenerative medicine offers a number of different benefits, including:

The following TED Talk gives a greater overview of the possible future benefits of this therapy.

The vast majority of early regenerative procedures were tissue-based, being developed for skin grafting. The first successful tissue that was engineered for grafting procedures was finalized in the 1970s, a mere eight years after the first synthetic tissue was developed. Howard Green and colleagues from Harvard Medical School began by harvesting a skin biopsy, later perfecting the practice of growing skin epidermis.

Following these advancements, researchers developed regenerative medical improvements in stem cell research, enabling successful bone marrow transplantation for individuals suffering from leukemia.

Having discovered the ability of the body to organize and regenerate tissue after cell death, researchers aimed their future studies at the goal of regenerative medicine and tissue engineering to replace tissue that had been damaged, lost through injury, or deteriorating with advanced age. Many diseases and injuries that result from failing tissue could potentially be successfully treated using regenerative medicine therapies.

Symptoms will vary patient to patient, but may include:

Pain is thought to be an indicator of tissue damage or an underlying injury. A number of existing treatments can help a patient cope with chronic pain, but dont fully address the underlying damage or injury. New regenerative medicine therapies can target the underlying problem and promote the bodys natural healing processes. Patients who experience the following list of conditions may be viable candidates for regenerative medicine.

Osteoarthritis is a chronic joint condition that causes degenerative cartilage changes in the joints. It is believed that the damage can be the result of wear and tear on the joint through a number of years or as a direct result of a specific injury. With enough damage to the cartilage that protects the joint, there is a high risk opposing bones will rub directly against each other. This direct contact causes damage to the ends of the bones and a significant inflammatory response and pain.

Traditional treatment approaches only help to manage the pain and not cure the condition. Stem cell therapy is believed to be more fitting since the goal is to repair the condition and reduce the bone-on-bone contact.

This is a degenerative condition of the individual bones of the spine, called vertebrae. Most commonly, spondylolisthesis occurs when the vertebrae slips over one another or becomes dislocated. Patients may experience nonspecific low back pain because a large number of individuals with this anatomical distortion do not present to their physician with related symptoms, including pain.

With spondylolisthesis the nerves around the weakened vertebrae can become compressed, resulting in pain and potentially muscle weakness. These symptoms can include:

Estimates are that 12% of the population has had difficulties with spondylolisthesis.

This common condition is characterized by a narrowing of the spinal canal. With spinal stenosis there is a restriction from this narrowing that results in neurogenic claudication. The spine is a row of 26 bones that allows movement and bending. Through the center is an opening, or canal, that protects the spinal cord. The narrowing with spinal stenosis can occur in the center, in the canals, or the spaces between the vertebrae. This narrowing puts pressure on the nerves in the spinal cord and can result in pain or numbness in the legs or shoulders, depending upon where the restriction is located.

Spinal stenosis is more common in individuals over the age of 50 years, but may occur in younger people who suffer an injury to the spine or are born with a narrowing of the spinal canal. Generally, pain specialists suggest using conservative or lifestyle changes to manage pain from this condition. If that doesnt work, patients may find relief with regenerative medicine techniques.

Spinal deformities are genetically linked issues that are related to the natural curvature of the spine. They generally involve the entire length of the spinal column and are relatively uncommon.

Conditions can affect the cervical, thoracic, or lumbar spinal regions and symptoms will vary widely depending upon the location. Some of these conditions are visible at birth, while others are only diagnosed when signs and symptoms develop.

A compression fracture is typically caused by osteoporosis and has a higher prevalence rate among post-menopausal women and in those individuals with a long history of corticosteroid use. These fractures result in a decrease in height of the vertebrae of at least 15 to 20%.

In one study, which examined 7,000 women over the age of 65, researchers found that 5% had suffered a compression fracture over a four-year period. Previous studies have suggested that nearly 4% of adults evaluated in a primary care setting could attribute back pain symptoms to a compression fracture.

Degenerative disc disease is a condition that results in symptoms from changes to the vertebral discs in adults as they age. The aging process increases the risk of tears to the disc, which is a likely cause of this type of pain. Spinal discs are soft and compressible that helps cushion the spinal column, which allows the spine to flex, twist, and bend. Although it can occur anywhere along the spine, it most often occurs in the lower back and neck. The pain can occur throughout the spine but in some instances affects the intervertebral disc.

Treatment modalities include physical therapy, pain medications, spinal fusion surgery, and steroid injections. New advances in regenerative medicine and stem cell therapy can help patients suffering from degenerative disc disease. Following extraction of the patients stem cells, usually from the bone marrow in the hip, the cells are engineered, concentrated, and injected into the site of the injury.

A herniated disc is characterized by damage to the intervertebral discs, which cause them to bulge from the intervertebral space or to rupture completely. The daily stress of movement, poor posture, injuries, and age can cause them to bulge, rupture, or herniate. The expansion of the disc material puts pressure on the surrounding nerves and spinal column, which is believed to be the source of pain. Herniated discs are more commonly found in aging people. Treatments include physical therapy, which has shown promise in relieving pain and improving the ability to function daily, however, it requires a significant time commitment in the therapists office and in daily home exercises.

Surgical treatment options may be suggested to cut out or remove the bulging or herniated material from the spinal column. The removal of the herniated disc carries a number of different risks related to the area of the spinal column where the disc is located and the weakened area of the column following surgery. Surgery is not always successful and there is a slight risk of damage to the spine or nerves, and risk of infection. New techniques from regenerative medicine using a patients own stem cells has shown good results with regeneration and rebuilding of the network of cells that make up the injured disc.

This is a common form of chronic foot pain that occurs between the ball of the foot and the heel. There is a thick connective tissue on the bottom of the foot, called the plantar fascia, which connects the ball of the foot to the heel. This plantar fascia supports the arch of the foot and can become strained from a number of different sources, including overuse, tight calf muscles, and poor foot placement. The damage forms tiny tears along the ligament, which is the likely source of pain. Treatments usually target the underlying condition, and then the symptoms of pain.

Regenerative medical treatments are an ideal choice for patients who have chronic pain in the plantar fascia and have corrected the underlying biomechanical issue that caused the initial condition. These therapies will promote healing of the damaged tissue. In fact, several studies provide realistic support for the use of platelet rich plasma therapy as an effective method of treatment to reduce or eliminate the pain associated with plantar fasciitis.

The sacroiliac joint is a large joint area that is located at the base of the spine. The joint connects the spine to the hip, or pelvis. In many cases, the individual can identify an injury that transpired previous to the onset of pain. Causes of this type of pain include:

There is limited evidence that current treatments are successful. Once a doctor relieves the underlying cause of pain, regenerative medicine may affect some degree of pain relief. This pain relief appears to last longer than that of steroid injections.

Also known as sciatica, lumbar radiculopathy occurs when a herniated disc, often between L5 and S1, pushes against the nerve. Patients experience pain that travels down the leg. The primary goal is to reduce the size of the disc and reduce the compression on the nerve root, thus reducing the pain.

There are a number of different treatment options for patients who suffer from lumbar radiculopathy. However, if they are unsuccessful, or if patients do not receive relief from their pain, they can be a candidate for stem cell injections.

In cervical radiculopathy, patients experience chronic pain originating from the cervical spine, or the neck area. When a disc in the neck pushes against a nerve root exiting the cervical spine, it causes pain to travel down the arms.

Radiculopathy in younger individuals can be from a herniated disc or neck injury. Older adults may suffer but physicians expect to also find osteophyte formation causing narrowing of the foramen, a reduced disc height and degenerative changes in the intervertebral joints.

Some patients who experience severe, unremitting back pain choose to undergo surgery to gain relief. Unfortunately, some patients may continue to suffer pain following surgical repair, which is recognized as a failed back surgery. Causes include:

Individuals with a history of other emotional disturbances, such as difficulty falling or staying asleep, depression, or anxiety are at an increased risk of developing chronic pain conditions following a back surgery.

Pain symptoms of a failed back surgery are usually dull, aching pain that is diffuse across the back and legs. Some patients do suffer from stabbing, pricking, or sharp pain in the limbs. When other treatments have failed to relieve pain following a failed back surgery, regenerative medicine treatment options might be considered.

Further, regenerative medicine therapies are relatively new and historically have very few studies documenting their effectiveness on different types of pain conditions. The FDA has not approved the use of adult stem cells to treat aging or to prevent, treat, or cure any disease or medical condition mentioned. Because of this, your insurance may not cover the cost of these procedures.

In addition, many regenerative medicine studies and treatments involve the use of living stem cells.Both legal and ethical issues are inherent in the use of embryonic stem cells. Although stem cell research holds great promise for the development of successful treatment modalities for conditions that thus far have no permanent treatment, research also raises both ethical and political controversies. However, reprogramming adult stem cells to produce pluripotent stem cells avoids these ethical issues that are specific to embryonic stem cell research. Adult or pluripotent stem cells are used for the majority of all regenerative pain medicine approaches, but always talk to your doctor if you have further questions.

To learn more about regenerative medicine for your pain condition, you can find a pain doctor in your area by clicking the button below or looking for one in your area by using the tips here: https://paindoctor.com/pain-management-doctors/.

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Regenerative Medicine Uses And Future Potential ...

F.D.A. Speeds Review of Gene Therapies, Vowing to Target …

So far, the drug agency has approved only two products that qualify as gene therapy Kymriah, from Novartis, and Yescarta, made by Kite Pharma. Both treatments involve genetically altering a patients own immune cells to fight leukemia or lymphoma. An advisory panel to the F.D.A. recommended approval for a third product, made by Spark Therapeutics, to correct a gene defect that causes a blinding hereditary eye disease. All three agency actions occurred this year.

Such treatments are extremely expensive, costing hundreds of thousands of dollars.

The prospect of faster approvals disturbs Michael Carome, director of Public Citizens health research group, an advocacy organization. Dr. Carome believes that the industry, still quite young, needs careful F.D.A. oversight.

I think there is excessive hype, Dr. Carome said. We are talking about rushing to market very complex biologics products where we are still in the infancy of this field.

The agencys announcements included two final guidelines and two drafts that will be open for public comment. They are designed to help developers sort out whether they need to submit a licensing application to the F.D.A. to get approval for their treatments or fall into a lower risk category, which does not need premarket approval.

One of the proposals would be a boon to small clinics and independent researchers. It would permit them to apply as a group and to pool data. If approved, each would end up with a license for biologics, a category that refers to treatments like cell, tissue and gene therapies that come from natural sources rather than being chemically synthesized.

The guidelines also detail steps to rein in the hundreds of stem-cell clinics that treat ailments by liposuctioning belly fat from patients and processing it to extract so-called stem cells, which are then injected back into the patients. These largely unregulated procedures have been offered for arthritic knees, back pain, heart disease and other problems.

Several patients have been blinded after fat-derived cells were injected into their eyes.

Practitioners who perform these procedures have argued that they do not come under the agencys jurisdiction. But the new guidance suggested that at least some of the fat-derived injections will be more tightly controlled by the F.D.A. The document stated that if the fat tissue is processed specifically to isolate stem cells as the stem-cell clinics do then the procedures must meet F.D.A. safety requirements.

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Stem cell Doctors Auburn Hills MI | knee pain treatment Auburn Hills MI

Stem cell Doctors Auburn Hills MI | knee pain treatment Auburn Hills MI

http://mihstem.com/ Stem Cell Seminars http://integrativehealthmi.com/ Stem Cell Website http://integrativehealthmi.com/testim... Video Testimonials

Here's just a taste of what you'll learn at this special live educational seminar: Learn about this remarkable cutting edge healing Stem Cell Doctors in Auburn Hills MI, technology that can actually repair damaged tissue in the body through a painless and safe stem cell injection. (Hint: Normal drugs just mask the pain.) According to Michigan Integrative Healths chief medical officer, "Patients can experience a significant decrease in pain and improved range of motion within weeks of just one treatment." When the body heals, the pain naturally goes away. Discover how stem cell injections work...Auburn Hills MI, Stem Cell Doctors Auburn Hills MI, (This is really fascinating stuff!) We'll explain how they pinpoint the impaired areas, remove the swelling with powerful anti-inflammatory properties and heal them by regenerating new cells and tissue. Why this innovative therapy is helpful for degenerative arthritis, degenerative cartilage and ligaments, bone spurs, degenerative joint disease, bursitis and tendonitis. Stem Cell Clinic in Troy MI, If you suffer from one of these or know someone who is in pain, this could be life-changing. Michigan Integrative Health is one of the first clinics in the area to offer this highly advanced form of therapy.

To reserve your seat at this informative seminar, click on one of the buttons on below or call (844) 644-7836 or (844) MIH-STEM. When you attend, youll receive a special reduced price consultation at the clinic to explore your stem cell therapy options. If you are unable to attend one of these seminar dates, Stem Cell Specialists in Troy MI, please call to schedule a consultation or find out about the next seminar

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Stem cell Doctors Auburn Hills MI | knee pain treatment Auburn Hills MI

Stem Cell Fraud: A 60 Minutes investigation – CBS News

The Internet is full of websites selling unproven stem cell treatments for incurable illnesses. Scott Pelley confronts one disgraced doctor offering false hope to a family with a disabled child.

The following is a script of "Stem Cell Fraud" which aired on Jan. 8, 2012, and was rebroadcast on Aug. 26, 2012. Scott Pelley is the correspondent. Oriana Zill and Michael Rey, producers.

(CBS News) There's no greater desperation than to be told that you, or your child, has a disease for which there is no hope. Many people with incurable illness look forward to the promise of stem cells. Stem cells have the potential to turn into any kind of cell and, in theory, they could repair damaged cells, though, scientists tell us that we are years away from realizing that dream.

There is no stem cell miracle today, so con men, have moved in to offer the hope that science cannot. Just look online and you will find hundreds of credible looking websites offering stem cell cures in overseas clinics.

Two years ago we began investigating stem cell charlatans. We worked with patients suffering from incurable diseases, and we discovered con men, posing as doctors, conducting dangerous medical experiments.

[Scott Pelley: You know, Mr. Stowe, the trouble is that you're a con man.]

Our report started a federal investigation and since that story, we have been digging into the rapidly growing trade in fake stem cell cures. As we reported last January, we've found something even more alarming: illegal stem cell transplants that are dangerous and delivered to your doorstep. They are scams that often bilk the desperate out of their last dollar of savings and their last ounce of hope.

[Brandon Susser: I know you're tired.]

Adam and Brandon Susser are 11-year-old twins. Adam has cerebral palsy, his brain was damaged by a lack of oxygen before he and his brother were born.

Gary Susser: He's confined to a wheelchair. He needs assistance with all his daily living activities from cleanliness to feeding, to clothing.

Gary and Judy Susser have searched for anything that might improve on the judgment handed down by Adam's doctors.

Gary Susser: The sentence of being a quadriplegic, the sentence of being totally blind, the pronouncement by physicians that we should put him away.

Scott Pelley: Those were the things that his regular doctors were telling you?

Gary Susser: Correct. We were being advised literally, "Put him away. He's gonna destroy your life."

So back in 2003, the Sussers took a chance on the theory of stem cells. Adam was three. They brought him to a doctor in Mexico who injected stem cells with no idea whether they would work.

Judy Susser: We both decided that in the severity of his condition that we'd have to try it.

Apparently, there was no harm and no miracle.

Gary Susser: The progress that he made after that was minimal at best and therefore we didn't see any good coming out of it.

Today, people like the Sussers can find hundreds of sophisticated websites offering stem cell treatments for every hopeless disease.

2012 CBS Interactive Inc. All Rights Reserved.

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Stem Cell Fraud: A 60 Minutes investigation - CBS News

Stem cell Doctors Troy MI | knee pain treatment Troy MI

Stem cell Doctors Troy MI | knee pain treatment Troy MI

http://mihstem.com/ Stem Cell Seminars http://integrativehealthmi.com/ Stem Cell Website http://integrativehealthmi.com/testim... Video Testimonials

Here's just a taste of what you'll learn at this special live educational seminar: Learn about this remarkable cutting edge healing Stem Cell Doctors in Troy MI, technology that can actually repair damaged tissue in the body through a painless and safe stem cell injection. (Hint: Normal drugs just mask the pain.) According to Michigan Integrative Healths chief medical officer, "Patients can experience a significant decrease in pain and improved range of motion within weeks of just one treatment." When the body heals, the pain naturally goes away. Discover how stem cell injections work...Troy MI, Stem Cell Doctors Troy MI, (This is really fascinating stuff!) We'll explain how they pinpoint the impaired areas, remove the swelling with powerful anti-inflammatory properties and heal them by regenerating new cells and tissue. Why this innovative therapy is helpful for degenerative arthritis, degenerative cartilage and ligaments, bone spurs, degenerative joint disease, bursitis and tendonitis. Stem Cell Clinic in Troy MI, If you suffer from one of these or know someone who is in pain, this could be life-changing. Michigan Integrative Health is one of the first clinics in the area to offer this highly advanced form of therapy.

To reserve your seat at this informative seminar, click on one of the buttons on below or call (844) 644-7836 or (844) MIH-STEM. When you attend, youll receive a special reduced price consultation at the clinic to explore your stem cell therapy options. If you are unable to attend one of these seminar dates, Stem Cell Specialists in Troy MI, please call to schedule a consultation or find out about the next seminar

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Stem cell Doctors Troy MI | knee pain treatment Troy MI

Knee – Regenexx

Have you been told that steroid injections or invasive surgery are your only options to treat your knee pain? Interventional orthopedics provides a non-surgical alternative that uses your own cells to repair the damage.

Recent research shows that some of the most popularorthopedic kneesurgeriesincluding meniscectomies have no benefit and are not more effective than placebo or sham surgery. Moreover, knee replacement is extremely traumatic and carries associated risks, and even successful surgeries minimally require months of painful rehab to regain strength and mobility. Most surgeries also accelerate degeneration that leads toosteoarthritis and exacerbate the biomechanical problems that initially led to the need for the surgery. Regenexx urges patients suffering from knee injuries or degenerative conditions to consider all of their options.

At Regenexx we invented a new approach to orthopedic care we call Interventional Orthopedics. This approach involves the use of image guidance (flouroscopy and ultrasound) to precisely place high-dose stem cells or platelets from your body directly where they are needed in a specific joint structure. These cells then work in the site of your injury to grow into new, healthy tissue, a process that will only occur if the cells have been placed exactly where they need to go in order to achieve positive outcomes for the patient.This precise approach to orthopedic care cant be replicated by a surgeon or nurse in a chiropractors office. Interventional Orthopedics requires thousands of hours of training following a standardized protocol process to become a licensed Regenexx physician.

The innovative Regenexx procedures restore knee function and mobility and decrease pain without the need for surgery by regenerating damaged tissue. During this outpatient procedure, ourexpert physiciansuseprecise image guidanceto inject custom concentrations ofyour body's natural healing agentsinto the exact areas of damage to tighten and stabilize your knee joint for better function and mobility.

This page contains an extensive library of educational resources on kneeconditions and our patented kneeprocedures created by Regenexx and our founder, Chris Centeno, M.D.. We encourage you to research your options.

GET RELIEF. 855-330-5818

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Knee - Regenexx

Stem Cell Clinics – eureka

When is a Stem Cell a Drug?

About a decade ago, stem cell clinics began popping up offering unapproved treatments for all kinds of debilitating and incurable diseases using a patients own fat stem cells.

There are now at least170 such clinics just in the US; many plastic surgeons doing liposuction have gotten on board. Stem cell clinics are even more popular outside the US, where they are part of the booming medical tourism industry. People travel all over the world for these treatments. In these cases the source of the cells and types of handling are not always clearly defined, making these treatments a safety concern.

The stem cell product generation involves collection of adipose tissue through liposuction, and isolation of the adipose stem cells with collagenase or other enzymes to create a stromal vascular fraction (SVF). This SVF is sometimes referred to as The Soup because of the lack of defined characteristics. The isolated product, which includes some stem cells, are then injected back into regions of the body from which the cells were not derived, which are referred to as non-homologous sites. The site of delivery depends on what condition is being treated but most of the potential administration sites (e.g., joints, muscles, circulatory system, central nervous system) are not homologous to the tissue of origin, the adipose tissue.

Fuzzy Guidelines

Some companies claim their treatments are approved by the US Food and Drug Administration (FDA), and tout cures for many incurable diseases and conditions, including Parkinsons disease, multiple sclerosis, autism, inflammation, all types of cancers and aging. But news reports have characterized the treatments as the modern-day version of snake oil, and stem cell organizations such as theCalifornia Institute for Regenerative Medicineand theInternational Society for Stem Cell Researchalong with the US National Institutes of Health consider many of these clinics dubious and have issued safety warnings to educate the public.The FDA has cautioned consumersto make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.

How can the use of a patients own cells be potentially dangerous? Some of the safety concerns arise from the extent of the manipulation and possible expansion of the cells outside the body. There are also concerns about the quality controls incorporated in the process, the characterization of the mixture, and complications from the administration back to the patient and the administration site.

It is very possible that some of these SVF treatments, especially for tissue pain and minor inflammation, have some level of therapeutic effect by facilitating tissue repair through release of trophic factors and/or induction of repair/regeneration pathways. However, the exact mechanisms are unknown and it is hard to evaluate the record of success of these therapies because stem cell clinics rarely publish data or findings.

Moreover, the FDA guidelines, until recently, were considered ambiguous concerning the classification and use of these autologous therapies. In the US, cell therapies are, legally, considered both biologics and drugs. They fall under the purview of theFood, Drug and Cosmetic Actbecause they mitigate, treat and prevent disease, but they also fall under the Public Health Service Act, sections351and361specifically, because they convey infectious disease.

Category 361 products are self-derived (autologous), minimally manipulated and used in a homologous manner, and do not need an Investigational New Drug (IND) approval, just an Institutional Review Board (IRB), a site registration and local (not FDA) oversight. Category 351 products are those that are more than minimally manipulated or ones that are used in a non-homologous manner. Marketed drug products fall into this 351 category. They require the whole drug development package (an IND, preclinical safety studies, clinical trials and marketing approval) before they can be prescribed to patients.

Not surprisingly, there has been much confusion over the product classification and definitions of these adipose-derived therapies, particularly over the interpretation of the phrases more than minimally manipulated and non-homologous use.

Minimizing Confusion

A year ago, in an effort to minimize interpretations from previous guidance, the FDA released two draft guidance:Minimal Manipulation of Human Cells, Tissues, And Cellular and Tissue-Based ProductsandHuman Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations. Both further define minimal manipulation and homologous use and provide many clear examples, some specifically addressing SVF.

In order to consider a cell product minimally manipulated, the processing must be shown not to alter the relevant characteristics or physical state of the tissue. For example, if the original characteristic of adipose tissue is to provide cushioning and support to tissues and organs, insulation, and energy storage capacity, then isolating just the adipose stem cells and removing the extracellular matrix that contributes to the tissues function would be considered more than minimally manipulated.

In order to meet the requirements for homologous use the cell product must be used in a tissue that performs the same basic function as the tissue of origin. For example, adipose tissue does not function in bone and joints and use of adipose tissue to treat bone and joint disease would be generally considered non-homologous use. Ultimately, these guidance provide more description for more-than-minimally manipulated, adipose-derived products and clearly state their non-homologous use meets the definition of a marketed drug product.

The intent of the guidance is to educate and provide clinics and doctors with proposed rules to self-correct and reduce the need for enforcement action once these guidelines are approved.

The Preclinical Process

As a result of these clarifying guidance documents, there are now many stem cell companies working through the process of obtaining regulatory approval for their autologous adipose-derived stem cell therapies. This approval will require product characterization and preclinical safety assessments similar to the expectations of a small-molecule or a biologic drug, which may includein vitroandin vivotesting.

The process can be relatively straight-forward and short-term, but ultimately the extent of testing depends on the cell product source, ex vivo manipulations, and use with other products and therapeutic indication. Navigating this preclinical process requires scientists that are familiar with the intricacies of the regulatory expectations, implementation of the testing requirements and performance of the assessments within the regulatory framework.

Assessing Risks

In this budding field of stem cell therapies, there is a lot of promise and still a lot of unknowns. Even with the most stringent and detailed characterization of the cell product and understanding of mechanisms of action, adverse interactions could occur. That is why these products are assessed with a tiered, risk-based approach designed by the FDA to provide the appropriate level of oversight to protect public health.

One case detailed last year inScientific Americandescribed the unintended consequences of not understanding altered cell characteristics of an isolated cell product and potential adverse interactions from chemical alterations. During a cosmetic treatment in 2009, a woman received some of her own adipose-derived stem cells along with some dermal filler to reduce the wrinkles around her eyes. The dermal filler compoundcalcium hydroxylapatiteis the same compound that stem cell researchers use to drive the undifferentiated stem cells down the bone pathway. In this case, the dermal filler differentiated the stem cells to bone and the patient ended up with bone fragments in the tissues surrounding her eyes, which had to be removed surgically.

This treatment met the requirements of a Category 361 product in that it was minimally manipulated and for autologous homologous use UNTIL it was combined with another product. This (thankfully not life-threatening) example of how stem cell treatments can go awry without proper understanding of product and potential interactions support the need for more safety-based oversight of these novel products.

Despite clarifications to the regulatory guidance and reports of adverse reactions in patients with SVF products, the battle rages on with some stem cell clinics. Physicians and stakeholders involved with autologous stem cell clinics are continuing to challenge the non-homologous use issue, claiming they are not creating drugs and that they are using approved materials. And these clinics continue to practice what they term transformative medicine.

In the end, we must have a better understanding of the cells, their activity and interactions before they are administered to humans. Otherwise, we could be creating more health problems for patients already seeking therapies for untreated conditions.

How to cite:

Jackman, Shawna. Stem Cell Clinics. Eureka blog. Nov 16, 2015. Available:http://eureka.criver.com/stem-cell-clinics/

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Stem Cell Clinics - eureka

Mayo Clinic finds surprising results on first-ever test of …

JACKSONVILLE, Fla. Researchers at Mayo Clinics campus in Florida have conducted the worlds first prospective, blinded and placebo-controlled clinical study to test the benefit of using bone marrow stem cells, a regenerative medicine therapy, to reduce arthritic pain and disability in knees.

The researchers say such testing is needed because there are at least 600 stem cell clinics in the U.S. offering one form of stem cell therapy or another to an estimated 100,000-plus patients, who pay thousands of dollars, out of pocket, for the treatment, which has not undergone demanding clinical study.

The findings in The American Journal of Sports Medicine include an anomalous finding patients not only had a dramatic improvement in the knee that received stem cells, but also in their other knee, which also had painful arthritis but received only a saline control injection. Each of the 25 patients enrolled in the study had two bad knees, but did not know which knee received the stem cells.

Given that the stem cell-treated knee was no better than the control-treated knee both were significantly better than before the study began the researchers say the stem cells effectiveness remains somewhat uninterpretable. They are only able to conclude the procedure is safe to undergo as an option for knee pain, but they cannot yet recommend it for routine arthritis care.

Our findings can be interpreted in ways that we now need to test one of which is that bone marrow stem cell injection in one ailing knee can relieve pain in both affected knees in a systemic or whole-body fashion, says the studys lead author, Shane Shapiro, M.D., a Mayo Clinic orthopedic physician.

Journalists, sound bites with Dr. Shane Shapiroare available in the downloads below.

MEDIA CONTACT: Kevin Punsky, Mayo Clinic Public Affairs, 904-953-0746, punsky.kevin@mayo.edu

One hypothesis is that the stem cells we tested can home to areas of injury where they are needed, which makes sense, given that stem cells injected intravenously in cancer treatments end up in the patients bone marrow where they need to go, he says. This is just a theory that can explain our results, so it needs further testing.

Another explanation is that merely injecting any substance into a knee offered relief from pain.

That could be, but both this idea and the notion that a placebo effect could be involved would be surprising, given that some patients are still doing very well years after their study treatment ended, says Dr. Shapiro.

He adds that these findings are important because while use of a patients own stem cells for regenerative therapy is extraordinarily popular, the treatments may be untested and are often poorly regulated.

Stem cell clinics often offer expensive treatments for conditions that range from multiple sclerosis, lung and heart disease, to cosmetic treatments, such as facelifts. None of these techniques have been studied because clinics maintain that use of a patients own cells is not a drug.

But, depending on how they are processed and used, stem cells can, in fact, be regulated by the U.S. Food and Drug Administration as biological products or drugs requiring rigorous safety and efficacy approval processes. In early September, the FDA held scientific meetings to clarify how to regulate such practices.

Mayo Clinic researchers developed their study with FDA approval.

We feel that if we are going to offer any stem cell procedures to our patients, the science needs to be worked out, Dr. Shapiro says.

The study was conducted in Mayos Human Cell Therapy Lab. Researchers extracted 60 to 90 milliliters of bone marrow from each patient, then filtered it, removed all blood cells, and concentrated it down to 4 to 5 milliliters. The solution, which contained tens of thousands of stem cells, was injected into a patients knee using ultrasound-guided imagery.

We actually counted all of the stem cells with markers that are accepted by the FDA, and we made sure they would be able to survive inside the patient, Dr. Shapiro says. Counting is expensive. Most clinics just draw the cells from bone marrow or fat and inject them back into the patient without checking for stem cells, hoping that patients get better, he says.

Dr. Shapiro and his colleagues are currently designing new studies that will test whether the stem cells home to distant areas of injuries, as well as exploring other implications suggested in their findings.

Study investigators include Mayo Clinic in Florida senior author Mary L. OConnor, M.D., Shari E. Kazmerchak, Michael G. Heckman, and Abba C. Zubair, M.D., Ph.D. Dr. OConnor is now at Yale University.

Funding for this study was from Mayo Clinics Center for Regenerative Medicine.

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About Mayo ClinicMayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing.For more information, visithttp://www.mayoclinic.org/about-mayo-clinicorhttps://newsnetwork.mayoclinic.org/.

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Stem Cell Transplant in Germany: Clinics, Cost, Price …

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Stem Cell Transplant in Germany: Clinics, Cost, Price ...