Clinics peddling unauthorized stem cell treatments face FDA heat
- Clinics nationwide are offering unregulated stem cell therapy for conditions ranging from autism, to multiple sclerosis and erectile dysfunction (ED). Some of the treatments cost as much as $25,000 and are offered without any oversight, Stat News reports.
- The FDA has issued draft guidance on stem cell therapeutics. According to the new guidance, homologous stem cells will now be regulated as a drug, device, and/or biological product under the Federal Food, Drug and Cosmetic Act.
- Towards that end, the agency late last year sent out warning letters to stem cell clinics in California, New York and Florida. The intent of the letters was to warn these clinics that they will now have to be FDA-licensed to offer stem cell therapeutics, and that like other drugs or medical devices, their products and services will have to be tested for efficacy and safety with proof that satisfies regulatory requirements.
The hearing on the recently issued draft guidance, "Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products," appears destined to be a packed event. On one side are critics of unregulated use of stem cells, a practice that many in the medical community have called "quackery."
Their main concern is that the treatments are not always what they purport to be. For instance, some may contain very few actual stem cells, along with other ingredients. It's also difficult to deliver on the promise of curing cancer with stem cells when there's no real existing evidence supporting this.
On the other side are proponents of clinic-based stem cell therapy such as Dr. Mark Berman, a Beverly Hills, CA-based cosmetic surgeon, who told Stat that he uses stem cells mixed with enzymes derived from fat (taken via liposuction) to not only address patients' cosmetic issues, but to also provide therapeutic relief of arthritis and joint pain.
While it's possible that some of the stem cell mixtures that various practitioners are using do work in some cases, the FDA wants more evidence and oversight on the matter. The meeting to review, discuss, and debate the draft guidance will take place at the FDA on April 13.