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Regenerative Science Inc., a US based clinic in Colorado issued a press release yesterday stating that the FDA has ordered them to stop treating patients with their own adult stem cells, a practice that the clinic says helps patients avoid other methods of invasive, orthopedic surgery. And, while the FDA is busy banning stem cell research in the USA, many patients with COPD and other health conditions are forced to go to other countries to get treatment, a practice that has many patients angry and frustrated.
Stem cell advocates believe that there is no better way to treat disease than enhancing the bodies own natural ability to heal itself. They also believe that the FDA is overstepping its authority and has no business trying to regulate stem cell treatment, and, are doing so in collaboration with pharmaceutical companies as a matter of self-interest.Regenerative Science Inc. has been safely using adult stem cells since 2005 to treat patients who have arthritis and other orthopedic conditions. In 2009, the FDA visited the clinic and said they were not compliant with drug mass manufacturing guidelines, but, they failed to take further action at the time.
Currently, the battle will ensue in a Colorado courtroom, as Regenerative Science Inc. has filed two lawsuits against the FDA in an effort to force the agency to respond to questions about jurisdiction in this matter. Last month, the clinic filed a Temporary Restraining Order against the FDA prompting them to take final action or leave the clinic alone.
To read more about this story, visit http://www.politicolnews.com/fda-stops-stem-cells-in-usa/
Stem cell advocates believe that there is no better way to treat disease than enhancing the bodies own natural ability to heal itself. They also believe that the FDA is overstepping its authority and has no business trying to regulate stem cell treatment, and, are doing so in collaboration with pharmaceutical companies as a matter of self-interest.Regenerative Science Inc. has been safely using adult stem cells since 2005 to treat patients who have arthritis and other orthopedic conditions. In 2009, the FDA visited the clinic and said they were not compliant with drug mass manufacturing guidelines, but, they failed to take further action at the time.
Currently, the battle will ensue in a Colorado courtroom, as Regenerative Science Inc. has filed two lawsuits against the FDA in an effort to force the agency to respond to questions about jurisdiction in this matter. Last month, the clinic filed a Temporary Restraining Order against the FDA prompting them to take final action or leave the clinic alone.
To read more about this story, visit http://www.politicolnews.com/fda-stops-stem-cells-in-usa/
If you see anything else please post. Thanks
hope it's wrong!
Apparently this does not apply to all stem cell clinics per the article below and has been an ongoing issue with this particular clinic. From what I gathered Costa Rica has been a haven for such clinics, too, and is also shutting some down also - for now, anyway.
Stem-cell therapy feels Food and Drug Administration's pinch
Reinjecting an adult's own cells requires study, agency says
By Jason Blevins
The Denver Post
Posted: 04/13/2010 01:00:00 AM MDT
Updated: 04/13/2010 09:21:05 AM MDT
Dr. Chris Centeno of Broomfield removes fluid from Jill Krenzelok's knee in order to collect stem cells. The cells will then be sent to a lab to be replicated and reinjected into her knee to facilitate healing. (Joe Amon, The Denver Post)
To 62-year-old Hal Kaye, the injection of his own stem cells into his battered ankle was a miracle cure that saved him from debilitating surgery.
To the Food and Drug Administration, the treatment pioneered by a Broomfield doctor appears to be a misuse of a drug that requires licensing and federal scrutiny before it's used on patients.
And that puts Dr. Chris Centeno on the front line of a simmering dispute over the use and regulation of adult stem cells, which can be cast as either a rogue therapy or breakthrough panacea.
Centeno says his procedure Regenexx is one of the first in the U.S. to bridge the gap between stem-cell research and actual treatment. Regenexx involves harvesting a patient's cells from bone marrow, growing more in a lab and then injecting the tissue-repairing cells into damaged joints or even lumbar discs.
Kaye is one of 500 patients who, since 2006, have paid several thousand dollars for a chance to regain their youthful bounce with Centeno's stem-cell therapy.
In Kaye's case, the treatment ended years of pain that five orthopedists said could be fixed only by fusing his ankle.
Today, three years after his stem-cell treatment, Kaye says he plays golf "whenever it's sunny."
"I can walk anywhere now," said Kaye, who hasn't used a cane since his Regenexx treatment. "It's been an incredible recovery."
But the FDA says stem cells are really a type of drug that requires intensive study and licensing.
The agency sent Centeno a letter in 2008 warning him that lack of FDA licensing for Regenexx appeared to be in violation of the Public Health Service Act. The FDA asked Centeno to write a letter detailing "steps you have taken or will take to address the violations."
Centeno, 46, sent a response to the FDA but said he has yet to receive a formal reply.
Centeno asserts that a person's own stem cells, which he magnifies in a culture of the patient's own blood in a controlled lab, are not a drug.
Dealing with the FDA
While Centeno circumvents the FDA, at least one other company is working with the agency to treat adults with their own stem cells.
In Louisiana, the 4-year-old TCA Cellular Therapy company has several ongoing FDA-approved clinical trials on humans, using patients' own stem cells to treat heart and vascular diseases. The company is waiting for FDA review of its plan for clinical trials using stem cells to treat spinal cord injuries and Amyotrophic Lateral Sclerosis, or ALS, known as Lou Gehrig's disease.
Centeno insists that the FDA exceeded its authority when, in an effort to prevent the spread of disease, it decided in 2005 that a patient's own stem cells should be regulated as if they were being used on another human.
But the medical community largely has supported the change.
An October 2006 report in the New England Journal of Medicine analyzed the FDA's updated regulation of stem-cell-based therapies. The report said researchers should be able to prove stem cells used won't transmit disease and will be pure, effective and safe. The authors concluded existing regulations governing stem cells "provide an appropriate structure for ensuring the safety and efficacy of the next generation of stem-cell-based products."
The International Cellular Medicine Society, which Centeno helped establish to set professional guidelines for adult stem-cell therapies and now counts 300 physicians in its ranks, is meeting this month with the FDA to discuss the issue of whether a patient's own cells classify as a regulated drug.
A hard-line stance by the FDA could force Centeno to go abroad with his Regenexx procedure, which he licenses to other doctors. Already he is helping to open a Regenexx clinic in an orthopedic hospital in China that specializes in medical tourism and caters to patients seeking unconventional medical treatment.
Harvesting, cultivating and three injections of stem cells at Centeno's clinic costs $8,000 and is not covered by most insurance policies.
Centeno's treatment, three 10-minute injections, can flood an area with as many as 40 million stem cells
Paul Pendleton paid $7,000 for adult stem-cell treatment to his left knee, which, he says, saved him from a knee replacement. He is back teaching his spinning classes at the Colorado Athletic Club. (Kathryn Scott Osler, The Denver Post)
roughly the size of a pea. By comparison, microfracture, a surgical technique that involves creating tiny breaks in a bone, bathes an injured joint in a few hundred thousand stem cells.
"The body sometimes has a hard time getting enough stem cells to an area, and what we do is simply amplify the number of cells," Centeno said.
Paul Pendleton is certain that adult stem-cell therapy could someday end joint-replacement surgery. He says it already saved him from replacing his knee.
He was about to give up decades of weightlifting and regular workouts when he found Centeno a year ago.
"It feels like my knee did 20 years ago. I'm back doing lunges, teaching my spinning classes," said the 53-year-old petroleum engineer. "The knee seems kind of bulletproof to me. It was a solution that conventional medicine could not offer."
Soon, regenerative stem-cell therapies like Centeno's may not be so cutting edge. A study published last month in the peer-reviewed journal Current Stem Cell Research and Therapy detailed the recovery of 227 Centeno patients. Using high-resolution MRIs, the study showed no patients developed tumors or other serious complications from the treatment.
"The safety has been quite good," Centeno said. "Especially when compared to other things like knee replacement or a big orthopedic surgery or microfracture or a laminectomy, the risk profile of this is far less than all of them."
Addressing safety issues
As doctors and researchers present more stem-cell therapies to the FDA, the regulatory process may move more quickly, said Dennis Roop, director of the new Center for Regenerative Medicine and Stem Cell Biology at the University of Colorado Denver's An schutz Medical Campus.
"But it will not ever evolve to the point where you don't have to address the safety issues," said Roop, noting that the FDA strictly regulates labs where tissues are grown. "If any physician thinks he can take cells out, expand them and grow them in his own clinic, the risk is something very similar to gene therapy, where there was so much hype and an adverse event can stymie the field for years."
In 2007, a 36-year-old Chicago woman died three weeks after her knee was injected with genetically engineered viruses as part of an investigational treatment researching gene therapy's potential in easing the pain of rheumatoid arthritis.
While the culture and climate for stem-cell therapies is improving, Roop said, more research, like Colorado State University's stem-cell work on dogs and horses, is needed to ensure safety and learn long-term effects of stem-cell therapies.
"I think as more data accumulates documenting safety, that will potentially accelerate getting more of these stem-cell therapies approved," he said.
Jo x
Here are some FAQ's sent to me from Regenerative Sciences. They welcome this lawsuit to get this matter settled once and for all. At stake here is adult stem cell therapy becoming a reality in the U.S. soon rather than in 10-20 years. It affects any doctor that wants to give such treatment to his patient. This issue goes far beyond Regenerative Sciences and its orthopedic treatments. The outcome of the lawsuit, one way or the other will have a major impact on the lives of the seriously ill in this country.
Barbara, that is very interesting, thanks so much for your responce, it explains a lot.
I wish they all who make these descisions live with what others that are ill have maybe they wouldn't be so quick to stop something that is helping.
what a world crazy just plain crazy.
I look at what they treated for it covers a lot of illnesses....
They will give you a free medical eval. That is one thing good I think?
Just thinking would it help us who also have COPD....it wasn't mention?
Desertbee and others - What would be really helpful would be to comment when you see press releases, blogs, forums, etc. that have this story. Patients need to make their voices heard. If you don't feel you know enough about the subject, just comment that you feel the practice of medicine should be between you and your doctor, not you and a government agency such as the FDA and that you don't feel like your own stem cells are drugs.
Also, I have been harping about offshore clinics needing to do a better job of documentation and clinical trials. This would help immensely rather than just patient testimonials. I have yet to see anything other than company generated press releases come from the clinic in Germany. You must be very careful when choosing a clinic and since stem cell therapy is in its infancy, realize that it is not a magic bullet. Realistic expectations are needed. Having therapy available in the state or country where you live, with your doctors using the patient registry and guidelines that the ICMS has developed, is what this fight is all about..
Autologous adult stem cell therapy is one of the safest types of treatments I can think of. Since these are your own stem cells, there is no chance of rejection. Thousands of these treatments have been done with no problems whatsoever. The most common types of autologous therapy for COPD are bone marrow, peripheral blood and adipose derived stem cell treatment.
I hope you all will take the time to make comments as I have suggested. This is the next generation of medicine and winning this lawsuit could mean the difference between having it available NOW vs. 10-20 years from now. Can you wait that long?
Members can do as they wish. Advertisements are to persuade people to buy products for the most part. My post was just to give members the info they need to take action if they wish on an issue that was brought up here.