The FDA’s ability to regulate the use of adult stem cells could be decided in court now that the agency is seeking an injunction to stop a Colorado medical practice from marketing its cultured cell product that regenerates bone and cartilage. Regenerative Sciences offers an autologous product known as Regenexx, made from a patient’s bone marrow or synovial fluid and blood. The materials are manufactured into a cultured cell product that is reinfused into the patient. The clinic contends that Regenexx is a medical procedure that uses patients’ own stem cells, but the FDA argues that it is an adulterated and misbranded drug.
Regenerative Sciences began culturing stem cells in 2005 and has treated roughly 500 patients using this method in the past several years.
"We have no problem with the agency or how it conducts its business but we think they're wrong on this one," said Dr. Christopher Centeno, Regenerative Sciences Medical Director. "Clearly for many of our patients this is going to limit their treatment options."
The clinic takes stem cells from patients, grows them in a lab to create greater numbers, then reinjects them in the area of an injury to speed healing. The FDA believes by "culturing" these stem cells, the facility is manufacturing a drug without the proper licenses.
'Culturing' would indeed seem to be the rub. The FDA has not challenged the use of Platelet Rich Plasma, which involves using an FDA approved medical device to concentrate autologous platelets and growth factors (cytokines) that stimulate bone and soft tissue healing.
By 'culturing' autologous bone marrow derived stem cells and 'growth factors' in the laboratory and then returning the result of the culturing to the patient, Regenerative Sciences has confronted the FDA definition of what constitutes a 'drug.' Now, it seems, a court will decide.
The court's decision could affect at least two of our Stem Cell Sector companies: Aastrom Biosciences and Opexa Therapeutics, both of which separate and culture autologous mesenchymal stem cells for use in patient therapy.
Adapted from the KWGN Denver story.