By Pat Anson, Editor
The U.S. Food and Drug Administration has warned a New Jersey biotechnology company to stop producing and marketing a stem cell product, the latest in a series of steps the agency has taken to rein in the fast growing stem cell industry.
The FDA sent a warning letter to American CryoStem Corporation for marketing adipose derived stem cells without FDA approval and for “significant deviations” from manufacturing guidelines.
American CryoStem is using adipose tissue – a patient’s own body fat – to create a product called Atcell, which is promoted as a treatment for stroke, brain injuries, Parkinson’s disease, amyotrophic lateral sclerosis (ALS) and multiple sclerosis.
The FDA said there was “more than minimal manipulation” of adipose tissue in the manufacturing of Atcell, which introduced the potential for contamination. The agency said Atcell should undergo clinical trials and an FDA review to prove its safety and effectiveness before being marketed.
“The use of Atcell raises potential significant safety concerns, due in part to the fact that there is little basis on which to predict how the product will perform in a patient,” said Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research. “In addition, this product may also cause harm to patients who may put their trust in an unproven therapy and make the decision to delay or discontinue medical treatments proven to be safe and effective.”
The FDA issued new guidelines for stem cell therapy last November, a “risk-based approach” that critics say could slow the development of novel treatments for autoimmune diseases, cancer, diabetes, neuropathy, back pain and other illnesses.
As PNN has reported, hundreds of stem cell clinics have opened around the country, often mixing hope with hype by making claims such as, “You don’t have to accept chronic pain as a fact of life.” The treatments are expensive and usually not covered by insurance.
Some patients receiving stem cell therapy have reported remarkable recoveries from chronic conditions once deemed untreatable. Sara Bomar, for example, was confined to a wheelchair after being diagnosed with arachnoiditis, a painful inflammation of nerves in her spinal column. She started walking again after a high dose infusion of stem cells made from her adipose tissue.
The warning letter to American CryoStem was sent nearly six months after FDA investigators inspected the company’s laboratory in Monmouth Junction, New Jersey, finding “significant safety concerns” and “objectionable conditions.” The firm has implemented changes at its lab to respond to the FDA’s concerns, however the agency said the response “inadequately addresses" the problems and failed to recognize that Atcell is an unlicensed product. The FDA gave the company 15 working days to respond to its warning letter.
American CryoStem did not respond to PNN’s request for comment. The company bills itself as a “biotechnology pioneer” in the use of adipose stem cells, and has laboratories in Hong Kong, mainland China and Japan. It recently licensed the patent rights to its stem cell technology in China and plans to expand its operations there.