Stem Cell Clinic

Denver Regenerative Medicine & Stem Cell Therapy

By Uncategorized

1. PRP Platelet Rich Plasma:Platelet rich plasma (PRP) injections are derived form a sample of the patients own blood. These injections contain plasma with higher concentration platelets than what is normally found in blood. PRP injections attempt to take advantage of the bloods naturally healing properties to repair damaged cartilage, tendons, ligaments, muscles, or even bone.

2. Amniotic Allografts:is allograft tissue derived from the amniotic membrane and fluid. Placental tissue is donated by healthy mothers at the time of scheduled cesarean section. Expectant mothers submit their past medical and social history and a detailed risk assessment is performed. Ultimately, approval of the tissue for use is made by the Medical Director following an intensive and complete medical review and prenatal evaluation prior to delivery. This tissue is rich with the basic components necessary for tissue regeneration including: Growth Factors, Cytokines, Collagen, Fibrinogen, Hyaluronic Acid, Messenger RNA.

Key Characteristics: The extracellular matrix of the amniotic membrane contains a high concentration of cellular scaffolding, cytokines, growth factors and proteins.

Ref: Predictive Biotech

3. Umbilical Cord tissue/blood: this regenerative medicine product is derived from Umbilical Cord Tissue Donations. This product contains mesenchymal stem cells (MSCs) and is rich in growth factors from umbilical cord tissue. These tissues are obtained under informed consents and strict ethical protocols. These tissues are from safe, reliable hospital sources via a non-invasive, simple, and painless procedure.

Key Characteristics: Whartons Jelly is a gelatinous substance in the umbilical cord that provides cushioning and support to the umbilical vein and arteries. The cushioning and protective elements from Whartons jelly consist of a network of structural proteins, pericytes, mesenchymal stem cells, cytokines, chemokines and growth factors. Ref: Predictive Biotech

Click here to view Cell Viability

4. Adipose tissue: Adipose-derived stem cells come from a patients fat tissue, which is surgically extracted via liposuction under general anesthesia.Adipose-derived stem cells are recognized as being an effective mesenchymal stem cell population with enormous potential in different fields of regenerative medicine and stem cell therapy. Although there is unanimous agreement on the harvesting procedure for adipose tissue, there are various protocols for adipose-derived stem cell isolation.

5. Bone Marrow: Adult stem cells can be extracted from bone marrow by aspiration, typically from the superior iliac crest or the sternum. The bone marrow aspiration (BMA) procedure is a concentrated serum of your own cells, the procedure is considered autologous point-of-care, and we do not expand or manipulate the marrow product other than placing it in a centrifuge.

We use an array of different regenerative treatment options. Based on a thorough history, consultation and evaluation, recommendations will be given on best option for your specific condition.

Research

We encourage people to look into regenerative medicine. There are currently over 4,000 clinical trials being conducted worldwide. Go to clinicaltrials for more information.

Downtowns Healthcare continues to review research, and put into play the most cutting edge treatments to help those who are interested in regenerative medicine.

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Denver Regenerative Medicine & Stem Cell Therapy

Regenerative Potential Of Induced Pluripotent Stem Cells …

By Induced Pluripotent Stem Cells

1020 0 Posted on Mar 26, 2019, 9 p.m.

After the discovery of induced pluripotent stem cells in the Nobel Prize winning lab of researcher Shinya Yamanaka at Kyoto University in 2006, the thick morality lined clouds hovering over embryonic stem cell research began to fade away making room for happier times.

Stem cells harvested from adults cells rather than embryos are less controversial and hold some promise for practical benefits as well such as lower chance of rejection by the immune system as they can be created from the patients very own cells. iPSCs are a versatile tool which is proving to be useful in modeling disease, screening drugs, and holds massive promise in the field of regenerative medicine.

Osaka and Cardiff Universities explored how iPSCs may be able to restore vision in humans. Using stem cells they were able to generate multiple cells lineages that resulted in tissues being implanted into the eyes of rabbits with induced corneal blindness which repaired the organ and restored their vision. This demonstrates various types of human stem cells are able to take on characteristics of the cornea, lens, and retinas which paves the way for trials to explore the technology in humans. according to Professor Andrew Quantock.

Kyoto University researchers explored the idea of using iPSCs to arrest the slide in decline of dopamine which hampers motor skills in those with Parkinsons disease, using diseased monkey brains with cells converted into dopaminergic progenitors responsible for generating dopamine neurotransmitters. The research has gone so well they are now conducting human trials using the same technology; 7 Parkinsons disease patients were given 5 million iPSC derived dopaminergic progenitors which were transplanted directly into their brains with a special device in hopes that it will curtail effects of the disease. The patients are being closely monitored and observed over the next two years.

University of Minnesota researchers have created a cutting edge technology wherein cells can be converted into neural stem cells, which can be mixed and matched with alternating layers of silicon scaffold to be used to grow new connections in the spine between the nerves that remain in spinal cord injury. In lab testing this technology was found to grow nerves and connect undamaged separated cells. Testing showed new neurons could be grown in an injury site, however the work is still a way off in doing so in numbers that would allow a paralyzed human to walk again. Even with that being said partial repairing of the spinal cord could still improve functions such as bladder control, avoid involuntary movement of limbs, and improve quality of life which is still plenty reason to be excited.

Washington University research has made a breakthrough with a method of converting iPSCs into beta cells which were tested by implanting into diabetic mice incapable of producing insulin on their own. The animals began secreting insulin on their own within days in quantities sufficient to control their own blood sugar levels which functionally cured their condition.

Following the successful trials on pigs in 2017 the Japanese government has recently approved the first ever trial on humans wherein iPSCs are being used to create sheets bearing millions of heart muscle cells which are then grafted onto the heart of human patients with heart disease. It is hoped with the help of growth factors these sheets will promote regeneration of damaged muscles and improve the function of the heart. This first of its kind trial involves 3 patients, if all goes well the team hopes to have a larger trial with 10 patients, followed by commercial availability of the technique if all goes according to plan.

There is no shortage of research into male pattern baldness, recently we are being shown how stem cells may play a role in hair revival, such as wherein scientists had converted iPSCs into epithelial stem cells which gave rise to hair follicle on the skin of immunodeficient mice. Another technique coaxed iPSCs into the form of dermal papilla cells which were transplanted into mice which triggered new hair growth. Research from the University of Southern California harvested skin cells from adults, molecular events behind their growth was examined and then replicated in iPSCs to grow new hair follicles in mice.

iPSCs are opening up a diverse array of exciting new medical possibilities. At only 13 years of discovery this very well is likely just the tip of the iceberg of many wonderful things to come. What a great time this could be for the future of the entire medical field and the possibility of regenerative medicine.

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Regenerative Potential Of Induced Pluripotent Stem Cells ...

Nutrition : The Addiction Recovery Guide

By Gene Therapy Clinics

In dealing with the chemical imbalances that are both a cause of substance abuse and a result of long-term substance addiction, nutritional therapy can be helpful in several ways.

Food and Addiction

Radiant Recovery (radiantrecovery.com/resourcecenter/alcdrug.html) This site was developed by Kathleen DesMaisons, PhD., the author of Potatoes not Prozac which charts the relationship between sugar addiction and alcoholism. It includes resources related to substance addiction plus an online program to help people deal with sugar addiction. There is also an online forum and a series of Internet-based two-week classes for $24.95 each which deal with various aspects of addiction including brain chemistry. Out-patient treatment based on this approach is also available in Albuquerque (call 505 345-3737 for further information).

Intravenous Amino Acids

Agora Regeneration Clinics (agoraforlife.net) Based in Vancouver, BC, this outpatient program focuses on biochemical detoxification of the body and brain. It includes Amino Acid IV Therapy, a Naturopathic physical work-up, infrared sauna detoxification, auricular acupuncture, massage therapy and the Agora For Life Program which deals with the emotional and mental aspects of addiction. The 10 day intensive program costs $9,800 (plus GST) and the 15 day intensive costs $13,500 (plus GST). Both program fees include the Agora for Life Aftercare program.

Nutritional Supplements, Vitamins and Herbs

Nutritional supplements such as herbs, amino acids (see chart below), vitamins and other nutrients restore the proper biochemical balance in the brain.

Supplements, vitamins and herbs can be purchased online through various websites such as Vitacost.com, iHerb.com, Swansonvitamins.com, Luckyvitamin.com, evitamins.com and Vitamin Shoppe.

Books on Nutrition

End Your Addiction Now: The Proven Nutritional Supplement Program That Can Set You Free by Charles Gant and Greg Lewis, published by Square One (2009) can be purchased at amazon.com. Nutritional supplements such as herbs, amino acids (see chart below), vitamins and other nutrients restore the proper biochemical balance in the brain. These supplements are specified, according to your addiction, in an excellent book written by Charles Gant, MD, PhD, who has helped over 7,500 patients with his innovative nutritional program designed to help people addicted to drugs, alcohol, nicotine, or pain medication.

In addition, eliminating certain substances such as sugars and simple starches and increasing protein intake can help to rebalance brain chemistry. Good nutrition can also help heal damage to the body caused by the depletion of nutrients common in substance abuse.

Natural Highs by Hyla Cass M.D. and Patrick Holford published by Avery Books/Penguin Putnam in 2002 can be purchased at amazon.com. This book usefully reviews and gives specific doses of herbs, amino acids, nutritional supplements and foods that help a person have a sharp mind and feel happy, calm, energetic and connected to people. The main tips from this book including specific doses of herbs and amino acids can be found at cassmd.com/books/naturalhighs/.

Another helpful book which has benefited many people with its nutritional advice is Seven Weeks To Sobriety: The Proven Program to Fight Alcoholism Through Nutrition by Joan Mathew Larson Ph.D. This book can also be purchased at amazon.com.

To Find a Nutritionist:

Academy of Nutrition and Dietetics (eatright.org) Some people may decide to work directly with a nutritionist. The Academy of Nutrition and Dietetics web site can help you locate a nutritionist. This is the nation's largest organization of food and nutrition professionals. Click on the red Find an Expert button at the top of the page to locate dietitians in the United States by zip code. Descriptions include areas of practice or specialty for each dietitian.

AMINO ACID NUTRITION THERAPY

Another important area of the use of nutrition in recovery and relapse prevention is the addition of appropriate amino acids that serve as the building blocks for powerful chemicals in the brain called neurotransmitters. These neurotransmitters, including epinephrine and norepinephrine, GABA, serotonin and dopamine, are closely tied to addiction behavior. With the use of various amino acids, brain chemistry can be changed to help normalize and restore deficiencies in the neurotransmitters that spur cravings that can lead to addiction andrelapse.

This chart was originally published in the following article. Blum K, Ross J, Reuben C, Gastelu D, Miller DK. "Nutritional Gene Therapy: Natural Healing in Recovery. Counselor Magazine, January/February, 2001

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Nutrition : The Addiction Recovery Guide

Platelet Rich Plasma | Medford | Ashland | Southern Oregon

By Platelet Rich Plasma Injections

What is Platelet Rich Plasma?

Platelet Rich Plasma (PRP) is a specially prepared sample of your blood in which all of the red blood cells (RBCs) have been removed and the platelets are concentrated to between 5-10 times that found in normally circulating blood. Platelets are the cells that circulate in your blood and will immediately identify and stick to any injured area in a blood vessel. They then create an immediate seal wherever there is a disruption of the vessel, and release proteins that start the tissue regeneration and healing. PRP can be used to promote healing in any area requiring a jump start in the bodys ability to heal injuries. PRP therefore is similar to other Regenerative Injection Therapies (RIT) such as Prolotherapy.

A syringe of your blood is drawn and placed in a machine called a centrifuge, which spins the blood to separate the platelets from the other blood components. The concentrated platelet fraction will then be extracted and prepared for injection into the injured area. The platelet concentrate is injected directly into the involved tissues. The platelets then become activated in that area and help your body to begin the healing process. Sometimes other boosters such as Stem Cells or Growth Factors can be mixed with the PRP for an even more robust response.

You should come to the procedure well rested and well hydrated. If you take any blood thinners or anti-inflammatory medications, be sure to discuss with Dr. Greenberg in advance whether these should be withheld for a period of time before the injection. Similar to other RIT treatments, such as Prolotherapy, it may take as long as a month to feel results of the procedure. You may experience pain after the procedure the first 48 hours this is the inflammatory phase. It is safe to apply ice or take Tylenol as instructed. It will then be necessary to evaluate your bodys response to the procedure to determine if repeat treatments are required for more complete relief.

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Platelet Rich Plasma | Medford | Ashland | Southern Oregon

Platelet Rich Plasma PRP injections for Plantar Fasciitis

By Platelet Rich Plasma Injections

Platelet rich plasma therapy (abbreviated as PRP) is a regenerative treatment for Plantar Fasciitis that consists on the injection of your own platelets to trigger the bodys natural repair and regeneration processes. PRP is effective in the treatment of several musculoskeletal conditions, including injury of tendons, ligaments, muscles and joints. PRP injections have been replacing traditional surgery for many orthopedic conditions ranging from soft tissue injuries (tendonitis, ligament injuries, muscle tears) to joint disorders, such as a meniscus tear or mild to moderate joint arthritis.

PRP therapy takes advantage of the fact that platelets have an important role in the process of wound and soft tissue healing, particularly when inflammation has developed. PRP therapy requires only a small amount of your own blood. This sample is centrifuged to obtain a fraction that has a high concentration of activated plateletsthe platelet rich plasma fraction. The PRP is then injected into the injured tissue to promote its healing.

The administration of these activated platelets causes a local response that promotes healing and regeneration. This treatment exerts beneficial effects through several mechanisms. These include:

We perform this procedure using ultrasound imaging to guide the injection. Ultrasound guidance increases the accuracy of the PRP administration, which may decrease pain following the procedure. We also use light activation to increase the efficacy of our platelets, which may also reduce any discomfort you may feel after the procedure. In general, PRP therapy requires only one session, but depending on the clinical characteristics of your Plantar Fasciitis, additional injections may be needed.

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Platelet Rich Plasma PRP injections for Plantar Fasciitis

10 talks on the future of stem cell medicine | TED Blog

By Stem Cell Medicine

Health TED Talks

Will the next generation think about diseases like Alzheimers and diabetes the way we think about polio and the whooping cough? Susan Solomon, the co-founder of the New York Stem Cell Foundation (NYSCF), certainly hopes so. In this fascinating talk from TEDGlobal 2012, Solomon delves into the foundations work on research with stem cells, which she calls the black boxes for diseases.

[Stem cells] are our bodies own repair kits. They are pluripotent, which means they can morph into all of the cells in our bodies, says Solomon. Right now there are some really extraordinary things that we are doing with stem cells that are completely changing the way we model disease, our ability to understand why we get sick and even develop drugs. But this field has been under siege, politically and financially.

While much of the fray is about embryonic stem cells still the gold standard when it comes to cells Solomon explains that another type of pluripotent stem cell (called iPS cells) can now be created by, essentially, reprogramming skin cells. These cells hold great promise for allowing researchers to see how diseases develop in humans, rather than in rodents.

Currently, developing a drug takes an average of 13 years, costs $4 billion, and has a 99% failure rate. And because its impossible to test a new drug on a large and representative sample of the human population, even a drug that tests well with many people will have side-effects for others, based on their genetic makeup. This is a problem thats sometimes not apparent until the drug is on the market and being prescribed to patients like in the tragic case of Vioxx.

Thats a terrible business model, but also is a horrible social model,she says. The way weve been developing drugs is essentially like going into a shoe store and no one asking what size you are They just say, Well, you have feet. Here are shoes.

From the TEDGlobal stage, Solomon outlined an exciting new approachher team at NYSCF has developed a machine that creates stem cell lines that, until now, had to be crafted by hand. NYSCF expects to produce 2,500 stem cell lines by the end of the year. The idea is to eventually produce a comprehensive array of 25,000 stem cell lines which act like avatars for a wide sample of people that researchers would have access to as they test new drugs.This could help avoid disasters and also let people know ahead of time of what side-effects they, specifically, can expect with a given medicine.

Two months after her talk, Solomon tells the TED Blog that interest in NYSCF work is growing. Pointing to a recent article in The New York Times about how future lung cancer treatments could be tailored to individuals, Solomon said, Its really the leading edge of where this field is going.

But Solomon stressed that it will be extremely difficult to change the current systems of drug development.

All the established companies have been using mouse-and-rodent testing forever, she said. A lot of peoples careers are staked to a method that is outdated. Its like the tech sector; this is really the high-tech sector for biomedical research.

To hear more about the NYSCF, watch Solomons talk. Below, watch 9 more talks about the incredible promise of stem cells.

Susan Lim: Transplant cells, not organsAs a woman, surgeon Susan Lim had to fight for the right to perform the first liver transplant in Asia. But she began to question the morality of such work given that with donor organs in such short supply many are coerced or forced to donate. Lim began looking at another approach: transplanting cells, rather than organs. In this talk, given at the INK Conference, she describes her work with adult stem cells derived from fat.

Daniel Kraft invents a better way to harvest bone marrowPediatrician and stem cell researcher Daniel Kraft has created a device to collect bone marrow in a way that is far less painful for both the patient and the doctor. In this talk from TED2009, Kraft shows how the stem cells found in this marrow could be used to treat heart disease and Parkinsons.

Eva Vertes: Do stem cells cause cancer?Microbiology prodigy Eva Vertes was 19 years old when she spoke at TED2005 about a theory that cancer might be a repair response to damaged stem cells in the lungs, liver, bones, etc. The implication she is testing? Its possible, although far-fetched, that in the future we could think of cancer being used as a therapy.

Alan Russell: The potential of regenerative medicineNot for the squeamish, in this talk from TED2006, medical futurist Alan Russell shows a video of stem cells being removed from a patients hip and injected directly into their heart and how this procedure has gotten much more precise over a short time. Such cell regeneration therapies will keep improving, Russell says.

Noel Bairey Merz: The single biggest health threat women faceWhile heart disease is often thought of as a male disease, Noel Bairey Merz explains that it is actually the biggest killer of women. In this talk from TEDxWomen 2011, Merz gives a call to arms for women to think of heart disease in the same way we do breast cancer, and talks about some exciting possibilities for treatment, including stem cell therapy.

Daniel Kraft: Medicines future? Theres an app for thatKraft, chair of the FutureMed program at Singularity University, talks about some of the big innovations coming down the pipeline in medicine. Near the end of this talk given at TEDxMaastricht, Kraft talks about cancer stem cells and how understanding them could lead to an era of personalized oncology the ability to leverage all of this data together, analyze the tumor and come up with a real, specific cocktail for the individual patient.

Juan Enriquez: The next species of humanFuturist Juan Enriquez believes that some big changes are coming, and that the next generation of humans could potentially be considered a different species. Why? In this talk from TED2009, he looks at the ability to engineer both cells and tissue, and describes some shocking ways researchers are using stem cells.

Kevin Stone: The bio-future of joint replacementArthritis affects more adults than cancer, says Kevin Stone in this talk from TED2010. While therapies using human tissue have been very promising in helping joint damage, there simply isnt enough donor tissue to go around. Stone explains a process which uses cartilage from a pig, loaded with a persons own stem cells, to ease pain and immobility.

Iain Hutchison: Saving facesIn this talk from TEDGlobal 2010 which contains some images of badly injured and disfigured faces that may be disturbing facial surgeon Iain Hutchison gives a look at his groundbreaking work. Towards the end of the talk, he describes an promising area of research tissue engineering which uses a patients own stem cells, taken from their hip, to help heal facial damage.

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10 talks on the future of stem cell medicine | TED Blog

Adult Stem Cell Therapy Is A Resounding Healing Success, So …

By Adult Stem Cells

Adult stem cell therapy is enjoying widespread success around the world, but if the FDA gets its way, it may soon be banned here in the U.S....

There have been nearly 12,000 adult stem cell therapies performed in the United States with an over 90 percent success healing rate for mostly joint and spinal conditions. It involves using the patients own stem cells, so no patent-able drugs are involved.

They are targeting the most influential stem cell scientist in the U.S., Dr. Kristin Comella in Florida.

Differentiating the Types of Stem Cell Therapy

They could be considered seeds for growing body tissues. They are mostly able to function for cellular repair and growth no matter what organ is in need of repair or healing from chronic inflammation.

There is a considerable controversy surrounding stem cell therapy research, a branch of regenerative medicine. Much of the controversy has to do with not differentiating between adult stem cell therapy and embryonic stem cell therapy.

Read: Scientists Discover That Fasting Triggers Stem Cell Regeneration & Fights Cancer

Embryonic stem cell therapy is the controversial one. It cultures or creates stem cells from terminated or aborted fetuses.

Currently, the FDA is harassing stem cell clinics that do not derive their stem cell solutions from aborted fetus tissue. They extract the stem cells from the patients own adipose tissue and inject them into areas where that same patient needs repair. Its an autologous process called adult stem cell therapy.

U.S. Stem Cell based out of South Florida is one of the clinics being targeted by the FDA, and the clinics Chief Scientist is Dr. Kristin Comella, PhD.

Many other nations have been using adult stem cell therapy successfully over the past 15 years, leaving the USA dead last in this field. The FDA is trying to make sure it stays that way and allows costly pharmaceutical versions to prevail.

Dr. Kristin Comella and her clinic have been under attack from the FDA.

This short 3-minute video was produced interviewing Dr. Comella and some of her patients.

Examining and Comparing the Different Types of Stem Cell Therapy

Human embryonic stem cell (hESC) therapy has received most of the medias attention and government support. But it is the most controversial because it involves extracting tissues from terminated human embryos, aka aborted fetuses.

In addition to moral and ethical issues, human embryonic stem cell (hESC) solutions create cells so rapidly where theyre injected they lead to cancerous tumors. To avoid that, researchers have to use immuno-suppressant drugs to curb the embryonic stem cells tendency toward cancer.

Using pharmaceutical drugs to curb hESC cancer side effect issues leads to other unexplored and unexpected side effects from those patented stem cell solutions.

But the profit motive for embryonic stem cell therapies was strong and a lot of government funds had been put into its research. Pharmaceutical companies were motivated because they could patent stem cells created from embryonic tissues.

Bone marrow stem cell therapy was among the first to depart from flawed hESC (human embryonic stem cell) therapies developed over the past two decades. Bone marrow stem cell therapy was the segue into the adult stem cell therapy movement.

Bone marrow extractions are painful, requiring general anesthesia. Its relatively difficult and expensive compared to adipose (fat) tissue stem cell harvesting.

Bone marrows high white blood cell count also encourages inflammation, making it counter-productive for patients already suffering from chronic inflammation or autoimmune disorders.

Most importantly, adipose (fat) tissue yields up to 500 times more mesenchymal stem cells than bone marrow sources, according to Dr. Comella. These are potent stem cells that can differentiate into a wide variety of other cell types. Furthermore, the adipose white blood cell count is lower than bone marrow matter.

Overactive, confused immune responses attack organs continually and create chronic inflammation and autoimmune diseases. The lower white blood cell count automatically lowers the risk of further inflammation among patients already suffering from chronic inflammation and autoimmune diseases.

The outpatient treatment involves creating a very small and shallow incision that wont require stitches on an area of skin covering adipose tissue (fat). From there, liposuction can withdraw a portion of the fat. This part of the procedure requires only a local anesthetic.

Then what is extracted is spun at high speed in a special centrifuge to isolate the stem cells which are then purified for IV drip delivery or injection into the same patient from whom it was extracted. Total costs range from five to ten thousand dollars or more in some cases.

Dr. Comella and her colleagues mission is to get adult stem cell therapy available for everyone. Private and government health insurance providers cover medical treatments that are much more expensive.

Why not cover one that would save money with its lower expense and fewer side effects?

Over the years, there have been nearly 12,000 adult stem cell therapies performed in the United States with an over 90 percent success healing rate for mostly joint and spinal conditions as well as heart and lung issues.

But the three known adverse side effect cases continually get all the media attention.

The Panama College of Cell Science, which helped launch Kristin Comellas research and development, had this to say about her:

"Perhaps the most influential clinician on the subject of adult stem cell therapy, Dr. Comella has been able to quietly develop patient treatment protocols and treat patients via collaborating physicians and health care providers using legal patient-specific FDA guidelines, including studies permitted by Institutional Review Boards, patient-specific stem cell clinical trials, and direct treatments using the patients own stem cells that are harvested and re-injected for therapeutic purposes.

"Through Dr. Comellas leadership, she and her team have trained and certified more than 700 physicians worldwide in adult stem cell therapy." (Source)

The interview below allows the energetic Dr. Kristin Comella to give a thorough and upbeat description of adult stem cell therapy.

Big Pharma Is Using the FDA to Eliminate Unregulated Adult Stem Cell Competition

Since the late 1990s, adult stem cells used therapeutically were not under the control of the FDA and the adult stem cell movement took off.

There were complaints from some MDs that the adult stem cell practice should be regulated by the FDA. The Panama College of Cell Science responded to those outcries with this statement:

"The motive in opposing adult stem cell therapy is money. The big institutions want to keep federal funding of embryonic stem cell research at a high level with the promise that cures are just around the corner despite the fact that embryonic stem cells will never be useful in any way for patient treatment because they immediately cause tumors when transplanted." (Source)

Adult stem cell therapy is an autologous treatment method. The stem cells are not lab-created. They are only isolated and purified after extracting them from the patient being treated. Injecting them back into that patient powers up the bodys own healing mechanism to overcome chronic ailments.

The FDA didnt and shouldnt have anything to do with regulating stem cells from ones own body. That situation has recently been arbitrarily and suddenly changed.

Around 2014, the FDA started tweaking their guidance rules for stem cell therapy with the purpose of getting new rules made into laws through Congress that could be interpreted according to FDA whims and enforced arbitrarily. Their agenda is to consider adult stem cells as FDA-regulated drugs.

During our phone conversation, Dr. Comella explained how the FDA ignored testimonies from adult stem cell practitioners during their 2015 public hearings regarding new guideline proposals. Then they arranged to create new rules behind closed door meetings that included pharmaceutical industry allies and insiders.

The result was that by 2017, the FDAs hands-off policy with adult stem cell therapy came to a sudden halt after years of highly successful stem cell practice.

By 2018, the FDA got nastier with the the most influential clinician on the subject of adult stem cell therapy as its target. The FDA started doing inspections of Dr. Comellas South Florida clinic that are designed for labs that manufacture drugs.

The standards for hospitals and clinics are not as strict as drug manufacturers. Those inspections were inappropriate for a clinic. But those inspections made it easier to create damaging reports.

When the inspectors came by, they demanded to go into rooms while treatments were taking place with semi-nude or nude patients, which Dr. Comella prohibited. The inspectors also demanded to view patient medical records. She allowed that after redacting their names on the copies she gave them.

For her actions to protect patients privacy, inspectors allegedly cited Dr. Comella for resisting and obstructing FDA inspections.

Soon after the inspections, the FDA served Dr. Comella with a lawsuit for practicing medicine with unapproved drugs. The drugs were only those stem cell solutions drawn from patients to be used on them.

The FDA has allegedly offered to drop the lawsuit if Dr. Comella signed an agreement to stop doing adult stem cell therapy and no longer promote it.

She refused. She said she has witnessed people leave their wheelchairs for good from this therapy. The trial is set for a Federal Court hearing beginning June 2019, in Miami, Florida.

If Dr. Comella loses this court case, adult stem cell therapy in the USA may be forced out of the country and only be available to those who can afford medical tourism.

Reference: HealthImpactNews.com

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Adult Stem Cell Therapy Is A Resounding Healing Success, So ...

FDA Wants to Shut Down Adult Stem Cell Therapy as its Healing …

By Adult Stem Cells

by Paul Fassa Health Impact News

Adult stem cell therapy is enjoying widespread success around the world, but if the FDA gets its way, it may soon be banned here in the U.S.

There have been nearly 12,000 adult stem cell therapies performed in the United States with an over 90 percent success healing rate for mostly joint and spinal conditions. It involves using the patients own stem cells, so no patent-able drugs are involved.

They are targetingthe most influential stem cell scientist in the U.S., Dr.Kristin Comella in Florida.

Many consider stem cell therapy the future of medicine. A stem cell can rebuild or create new cells in tissues, even in organ tissues other than those from which they had originally existed.

They could be considered seeds for growing body tissues. They are mostly able to function for cellular repair and growth no matter what organ is in need of repair or healing from chronic inflammation.

There is a considerable controversy surrounding stem cell therapy research, a branch ofregenerative medicine. Much of the controversy has to do with not differentiating between adult stem cell therapy and embryonic stem cell therapy.

Embryonic stem cell therapy is the controversial one. It cultures or creates stem cells from terminated or aborted fetuses.

Currently, the FDA is harassing stem cell clinics that do not derive their stem cell solutions from aborted fetus tissue. They extract the stem cells from the patients own adipose tissue and inject them into areas where that same patient needs repair. Its an autologous process called adult stem cell therapy.

U.S. Stem Cell based out of South Florida is one of the clinics being targeted by the FDA, and the clinics Chief Scientist isDr. Kristin Comella, PhD.

Many other nations have been using adult stem cell therapy successfully over the past 15 years, leaving the USA dead last in this field. The FDA is trying to make sure it stays that way and allows costly pharmaceutical versions to prevail.

Dr. Kristin Comellaand her clinichave been under attack from theFDA.

This short 3-minute video was produced interviewing Dr. Comella and some of her patients.

Human embryonic stem cell (hESC) therapy has received most of the medias attention and government support. But it is the most controversial because it involves extracting tissues from terminated human embryos, aka aborted fetuses.

In addition to moral and ethical issues, human embryonic stem cell (hESC) solutions create cells so rapidly where theyre injected they lead to cancerous tumors. To avoid that, researchers have to use immuno-suppressant drugs to curb the embryonic stem cells tendency toward cancer.

Using pharmaceutical drugs to curb hESC cancer side effect issues leads to other unexplored and unexpected side effects from those patented stem cell solutions.

But the profit motive for embryonic stem cell therapies was strong and a lot of government funds had been put into its research. Pharmaceutical companies were motivated because they could patent stem cells created from embryonic tissues.

Bone marrow stem cell therapy was among the first to depart from flawed hESC (human embryonic stem cell) therapies developed over the past two decades.Bone marrow stem cell therapy was the segue into the adult stem cell therapy movement.

Bone marrow extractions are painful, requiring general anesthesia. Its relatively difficult and expensive compared to adipose (fat) tissue stem cell harvesting.

Bone marrows high white blood cell count also encourages inflammation, making it counter-productive for patients already suffering from chronic inflammation or autoimmune disorders.

Most importantly, adipose (fat) tissue yields up to 500 times more mesenchymal stem cells than bone marrow sources, according to Dr. Comella. These are potent stem cells that can differentiate into a wide variety of other cell types. Furthermore, the adipose white blood cell count is lower than bone marrow matter.

Overactive, confused immune responses attack organs continually and create chronic inflammation and autoimmune diseases. The lower white blood cell count automatically lowers the risk of further inflammation among patients already suffering from chronic inflammation and autoimmune diseases.

The outpatient treatment involves creating a very small and shallow incision that wont require stitches on an area of skin covering adipose tissue (fat). From there, liposuction can withdraw a portion of the fat. This part of the procedure requires only a local anesthetic.

Then what is extracted is spun at high speed in a special centrifuge to isolate the stem cells which are then purified for IV drip delivery or injection into the same patient from whom it was extracted. Total costs range from five to ten thousand dollars or more in some cases.

Dr. Comella and her colleagues mission is to get adult stem cell therapy available for everyone. Private and government health insurance providers cover medical treatments that are much more expensive.

Why not cover one that would save money with its lower expense and fewer side effects?

Over the years, there have been nearly 12,000 adult stem cell therapies performed in the United States with an over 90 percent success healing rate for mostly joint and spinal conditions as well as heart and lung issues.

But the three known adverse side effect cases continually get all the media attention.

The Panama College of Cell Science, which helped launch Kristin Comellas research and development, had this to say about her:

Perhaps the most influential clinician on the subject of adult stem cell therapy, Dr. Comella has been able to quietly develop patient treatment protocols and treat patients via collaborating physicians and health care providers using legal patient-specific FDA guidelines, including studies permitted by Institutional Review Boards, patient-specific stem cell clinical trials, and direct treatments using the patients own stem cells that are harvested and re-injected for therapeutic purposes.

Through Dr. Comellas leadership, she and her team have trained and certifiedmore than 700 physicians worldwide in adult stem cell therapy. (Source)

The interview below allows the energetic Dr. Kristin Comella to give a thorough and upbeat description of adult stem cell therapy.

Since the late 1990s, adult stem cells used therapeutically were not under the control of the FDA and the adult stem cell movement took off.

There were complaints from some MDs that the adult stem cell practice should be regulated by the FDA. The Panama College of Cell Science responded to those outcries with this statement:

The motive in opposing adult stem cell therapy is money. The big institutions want to keep federal funding of embryonic stem cell research at a high level with the promise that cures are just around the corner despite the fact that embryonic stem cells will never be useful in any way for patient treatment because they immediately cause tumors when transplanted. (Source)

Adult stem cell therapy is an autologous treatment method. The stem cells are not lab-created. They are only isolated and purified after extracting them from the patient being treated. Injecting them back into that patient powers up the bodys own healing mechanism to overcome chronic ailments.

The FDA didnt and shouldnt have anything to do with regulating stem cells from ones own body. That situation has recently been arbitrarily and suddenly changed.

Around 2014, the FDA started tweaking their guidance rules for stem cell therapy with the purpose of getting new rules made into laws through Congress that could be interpreted according to FDA whims and enforced arbitrarily. Their agenda is to consider adult stem cells as FDA-regulated drugs.

During our phone conversation, Dr. Comella explained how the FDA ignored testimonies from adult stem cell practitioners during their 2015 public hearings regarding new guideline proposals. Then they arranged to create new rules behind closed door meetings that included pharmaceutical industry allies and insiders.

The result was that by 2017, the FDAs hands-off policy with adult stem cell therapy came to a sudden halt after years of highly successful stem cell practice.

By 2018, the FDA got nastier with the the most influential clinician on the subject of adult stem cell therapy as its target. The FDA started doing inspections of Dr. Comellas South Florida clinic that aredesigned for labs that manufacture drugs.

The standards for hospitals and clinics are not as strict as drug manufacturers. Those inspections were inappropriate for a clinic. But those inspectionsmade it easier to create damaging reports.

When the inspectors came by, they demanded to go into rooms while treatments were taking place with semi-nude or nude patients, which Dr. Comella prohibited. The inspectors also demanded to view patient medical records. She allowed that after redacting their names on the copies she gave them.

For her actions to protect patients privacy, inspectors allegedly cited Dr. Comella for resisting and obstructing FDA inspections.

Soon after the inspections, the FDA served Dr. Comella with a lawsuit for practicing medicine with unapproved drugs. The drugs were only those stem cell solutions drawn from patients to be used on them.

The FDA has allegedly offered to drop the lawsuit if Dr. Comella signed an agreement to stop doing adult stem cell therapy and no longer promote it.

She refused. She said she has witnessed people leave their wheelchairs for good from this therapy. The trial is set for a Federal Court hearing beginning June 2019, in Miami, Florida.

If Dr. Comella loses this court case, adult stem cell therapy in the USA may be forced out of the country and only be available to those who can affordmedical tourism.

Published on March 11, 2019

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FDA Wants to Shut Down Adult Stem Cell Therapy as its Healing ...

Past Years of Hype Notwithstanding, Adult Stem Cells Are Now …

By Adult Stem Cells

During the Great Embryonic Stem Cell Debate, circa 2001-2008, I watched the scientistsblatantly lie about the supposedly low potential for adult stem cells and the CURES! CURES! CURES that were just around the corner from embryonic stem cells. You remember: Children would soon be out of their wheelchairs and Uncle Ernies Parkinsons would soon be a disease of the past.

The pro-ESCR campaign was filled with so much disinformation and hype willingly swallowed by an in-the-tank media all in a corrupt attempt to overturn the minor federal funding restrictions over ESCR imposed by the President, and to hurt President Bush politically.

After the Bush presidency, the issue became quiescent. And now, it turns out that the clinical advances that have been made are not from embryonic stem cells.

During the debate, David A. Prentice a stem-cell researcher and my good friend took a sabbatical from his Indiana State University professorship to tout the great potential of adult stem cells (and to oppose human cloning) around the world. He became quite prominent in the debate for which he was punished by his universitys administration. For example, despite receiving teaching awards, he was moved from graduate classes and his lab privileges were curtailed.

Prentice eventually headed for The Swamp to continue his advocacy. He is now with the Charlotte Lozier Institute, where he has continued to track and educate about stem-cell science and engage policy controversies.

Prentice just published a major peer-reviewed article in the science journal Circulation Research, in which he details the amazing successes of adult stem-cell research demonstrating that the ESCR hypers had it wrong and he had it right.

Prentice outlines the many problems that make embryonic stem cells ill suited for clinical use, including the difficulty ofdifferentiating and integrating ES cells into the body, the problem that these cells have shown evidence of causing arrhythmia, the potential to cause tumors, and immunogenicity, in real peoples language, rejection caused by triggering the bodys immune response.

In contrast, ethical stem cells have had excellent successes. For example, induced pluripotent stem cells, which can be made from normal skin cells, are splendid for use in cell modeling and drug testing.

But Prentices primary focus is on adult stem cells, often taken from donor bone marrow or a patients own body. They have also not advanced as fast as was hoped, but they are progressing into clinical uses and human studies. From, Adult Stem Cells:

Not only do adult stem cells carry no ethical baggage regarding their isolation, their practical advantages over pluripotent stem cells have led to many current clinical trials, as well as some therapies approved through all phases of Food and Drug Administration testing.

Peer-reviewed, published successful results abound, with numerous papers now documenting therapeutic benefit in clinical trials and progress toward fully tested and approved treatments. Phase I/II trials suggest potential cardiovascular benefit from bone marrowderived adult stem cells and umbilical cord bloodderived cells.

Striking results have been reported using adult stem cells to treat neurological conditions, including chronic stroke. Positive long-term progression-free outcomes have been seen, including some remission, for multiple sclerosis, as well as benefits in early trials for patients with type I diabetes mellitus and spinal cord injury. And adult stem cells are starting to be used as vehicles for genetic therapies, such as for epidermolysis bullosa.

If this progress had been derived from embryonic stem cells, the headlines would have been deafening. The cheering from the media would include anchors dancing with pom-poms!

But the media isnt much interested in reporting adult stem-cell successes prominently because doing so doesnt promote favored ideological agendas. Thats not good journalism.

Prentice concludes:

The superiority of adult stem cells in the clinic and the mounting evidence supporting their effectiveness in regeneration and repair make adult stem cells the gold standard of stem cells for patients.

Thats excellent news for everyone, and may it continue.

But as we benefit from these ethical treatments, the next time ideologically driven scientists, bioethicists, and their media water carriers seek to drive public opinion on scientific issues in a partisan direction by deploying the propaganda tools of hype, exaggeration, and castigation of those who espouse heterodox views, remember how the Great Stem Cell Debate turned out.

Photo: An adult stem cell, by Robert M. Hunt [CC BY 3.0], via Wikimedia Commons.

Cross-posted at The Corner.

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Past Years of Hype Notwithstanding, Adult Stem Cells Are Now ...

Induced Pluripotent Stem Cell (iPSC) Media and Reagents for …

By Induced Pluripotent Stem Cells

Advancing your induced pluripotent stem cells or human embryonic stem cell therapy research to clinical applications requires careful material selection because the quality of starting materials significantly impact the properties of your final stem cell therapy product. Gibco CTS products have been developed to ease the transition from stem cell therapy research to clinical applications by providing high quality GMP manufactured, commercial scale ancillary materials with a high degree of qualification, traceability and regulatory documentation. In an effort to help you maximize the potential of your stem cell research and therapy, and simplify the transition to clinic-ready processes, we offer an extensive selection of research use stem cell research products with complementary CTS formulations. Our CTS products are used in commercially approved cell therapies as well as over 100 clinical trials and are backed by our professional regulatory support and over 30 years of GMP manufacturing experience.

Induced pluripotent stem cells (iPSCs) and embryonic stem cells (ESCs) , sometimes collectively referred to as pluripotent stem cells (PSCs), are cells that have the ability to renew themselves indefinitely and differentiate into almost any cell type when exposed to the right microenvironment. These unique properties enable the application of induced pluripotent stem cells and embryonic stem cells in disease modeling, drug discovery, drug toxicity testing, and cell therapy. Strikingly, most embryonic stem cell and induced pluripotent stem cell applications have the potential to improve human health, none more directly so than ESC or iPSC therapy. The most intuitive approach for ES or iPS cell therapy is to transplant PSC-derived cells for the direct replacement of damaged or degenerated cells or tissue. However, there are many other approaches to ES or iPS stem cell therapy such as transplanting PSC-derived cells that then release signals triggering endogenous repair mechanisms.

At Thermo Fisher Scientific, we support the development of your human embryonic stem cell therapy or induced pluripotent stem cell therapy from the earliest stages of research and all the way to the clinic. We offer high-quality products across the iPS cell therapy workflow from reprogramming to differentiation. Most Gibco media and supplements for culture and differentiation are manufactured under GMP conditions at sites that use methods and controls that conform to current Good Manufacturing Practices (cGMP) for medical devices. These FDA-registered manufacturing sites are ISO 13485 and ISO 9001certified, and the rigorous practices we adhere to at these sites help ensure the consistency, reliability, and high quality of a wide variety of iPSC therapy workflow reagents.

To further help you maximize the potential of your research and streamline your transition to the clinic, we offer Gibco Cell Therapy Systems (CTS) equivalents for many of our research-use products. In addition to GMP manufacturing, Gibco CTS products undergo extensive safety testing and are accompanied by appropriate documentation so you can transition your cell therapy to the clinic with confidence.

*Adherence to supplier related responsibilities of USP<1043>

First off-the-shelf reprogramming system manufactured in accordance with GMP requirements. CTS CytoTune 2.1 kit offers high-efficiency Sendai delivery of reprogramming factors.

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Efficient reprogramming from adult human dermal fibroblasts, T cells, and CD34+ cells. These data demonstrate that the CytoTune-iPS 2.1 kit can be used to successfully reprogram human dermal fibroblasts (HDFa), T cells, and CD34+ cells.

Based on the widely cited Gibco Essential 8 Medium, Gibco CTS Essential 8 Medium is the first globally available human- and animal originfree culture medium for human pluripotent stem cells (hPSCs) and is designed to meet international regulatory requirements for cell therapy.

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Using Applied Biosystems TaqMan hPSC Scorecard Panel analysis, Gibco CTS Essential 8 Medium and research-use-only Essential 8 Medium were shown to support comparable expression of PSC markers and lineage markers in undifferentiated PSCs and PSC-derived embryoid bodies.

CTS Vitronectin (VTN-N) Recombinant Human Protein is a defined matrix for feeder-free culture of iPSCs. Designed in the laboratory of James Thomson, this recombinant protein is intended for use with the CTS Essential 8 culture system.

CTS RevitaCell Supplement (100X) is an animal-origin-free, chemically defined supplement used with PSCs for post-thaw recovery or in combination with CTS Essential 8 Medium for single cell passaging. To minimize both the loss of cell viability and differentiation of PSCs, use the CTS PSC Cryopreservation Kit.

CTS Versene is a gentle non-enzymatic cell dissociation reagent for use in routine clump passaging of PSCs while maintaining viability over multiple passages.

For the cryopreservation and recovery of PSCs, the CTS PSC Cryopreservation Medium and CTS RevitaCell Supplement minimize the loss of cell viability and maximize post-thaw recovery when used in combination. Both reagents are included in the CTS PSC Cryopreservation Kit.

The CTS PSC Cryopreservation Medium is a xeno-free solution for the cryopreservation of pluripotent stem cells (PSCs). Both CTS PSC Cryopreservation Medium and CTS RevitaCell supplement are included in the CTS PSC Cryopreservation Kit that helps minimize loss of cell viability and maximize post-thaw recovery.

CTS KnockOut SR XenoFree Medium is a defined, xeno-free serum replacement based on the traditional Gibco KnockOut Serum Replacement, which has been cited in more than 2,000 publications and trusted for over 20 years.

Maintenance of pluripotency using CTS KNOCKOUT SR XenoFree Medium. Following 10 passages in either KSR (left lane) or KSR XenoFree CTS (right lane) on HFF attached with CELLstart substrate, BG01v gene expression was examined (top). Gene expression of embryoid bodies generated from the same P10 BG01v/HFF cultures (bottom).

Your choice of chemically defined human- and animal origin-free basal media for pluripotent stem cell culture. Based on traditional DMEM and DMEM/F12 formulations, these basal media are:

Gibco CTS growth factors help enable you to easily qualify reagents during your transition from research applications to clinical applications. CTS products are supplied with harmonized documentation such as Certificates of Analysis and Certificates of Origin.

CTS offers high-quality growth factors and cytokines for T cell, stem cell and dendritic cell applications.

CTP0261,CTP0263,CTP9211,CTP9213,CTP2111,CTP2113,CTP9411,CTP9413

We offer full customization options to help meet your unique specifications for any project. Flexibility is yours in creating your own Gibco custom cell culture medium

Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.

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