The U.S. Food and Drug Administration (FDA) has announced a public hearing on Sept. 12 and Sept. 13 on draft guidelines for stems cell therapies that are being practiced in a number of clinics without the agency's approval.
In one of the recent studies published in the journal Cell Stem Cell, it was noted that about 570 clinics in the country are performing expensive stem cell therapies for a wide range of problems including cosmetic and health concerns. About 113 clinics offering such treatments operate in California alone, said the authors of the study, Paul Knoepfler of the University of California, Davis and Leigh Turner of the University of Minnesota.
The researchers pointed out that many companies across the country that use stem cells for treatment don't adhere to federal regulations. Clinics that use stem cells derived from a person's own fat claim that the products are exempted from the FDA's approval process as the fat cells are minimally manipulated and cannot be considered as drugs, noted California Healthline.
However, the FDA had sent a warning notice to a doctor regarding the issue late last year. It was noted in the letter that the processing of fat cells in the clinic doesn't match what the agency terms as "minimal manipulation" and that the fat-derived stem cell products do not meet the criteria under the Code of Federal Regulations. They are therefore considered as drugs and subject to federal approval. As an initiative to come up with a solution for the problem, the agency has proposed a public hearing meeting.
"The purpose of the public hearing is to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) from a broad group of stakeholders, including tissue establishments, biological and device product manufacturers, health care professionals, clinicians, biomedical researchers and the public," says the FDA in a press release.
Dr. Luis Garza, a dermatologist at the Johns Hopkins School of Medicine who is working on improving health care for amputees through skin stem cells, said that the "public's enthusiasm" on treatments of the sort are being exploited commercially by some people. Almost 99.9 percent of the information on the therapies given is untrue, he added.
However, some patients who believe they have benefited from such therapies have a different view on the issue. Nashville resident Doug Oliver, who underwent stem cell therapy for macular degeneration, said that people have the right to make decisions on the tissues and cells from their body. The 54-year-old, who almost lost his eyesight as a result of the rare disease, said that his vision improved enough to be able to drive after therapy.
The FDA public hearing on drafted guidelines for stem cell therapies will be held until 5:00 pm of Sept. 13 at the Masur Auditorium at the National Institutes of Health Campus in Bethesda, Maryland.
Photo: University of Liverpool Faculty of Health & Life Sciences | Flickr
