FDA cracks down on unapproved stem cell therapies
Stem cell therapy seems an intriguing opportunity in integrative medicine, but U.S. Food and Drug Administration (FDA) is cracking down on clinics that offer such methods of treatment.
Thought to treat or prevent chronic diseases and injuries, stem cell therapy, or regenerative medicine, involves implanting specialized cells into a person. For example, if a person has heart disease, the cells could be injected into the heart muscle, and the healthy transplanted cells could then contribute to repairing defective heart muscle. A common form of this type of therapy is a bone marrow transplant.
Some clinics are performing fat-derived stem cell therapy, where a practitioner removes a small amount of a person’s fat, processes it, and inject it back in to them. This is thought to jump-start the healing process. The therapy is not FDA-approved, though hundreds of clinicians and clinics across the U.S. offer fat-derived stem cell therapy, according to the Cell Surgical Network.
In 2017, three FDA scientists published a report in the New England Journal of Medicine noting that the lack of evidence is concerning. In May 2018, the Department of Justice, on behalf of the FDA, sued clinics in California and Florida for “experimenting on patients with misleading products.”
Currently, the only stem cell therapy that is approved by the FDA is the aforementioned bone marrow transplant. Doctors in the Cell Surgical Network, according to their website, use cells to treat autoimmune, neurologic, and other chronic and serious diseases.
In December, the U.S. Centers for Disease Control and Prevention (CDC) reported 12 cases where patients suffered bacterial infections from contaminated stem cell treatments. The cases were traced back to Genetech Inc., which prompted a warning letter issued by the FDA shortly after. Representatives from Genetech Inc. responded, noting they would take steps to regulate unapproved treatments.
Scientists and bioethicists are also expressing concern, and in a recent paper published in the journal Perspectives in Biology and Medicine, authors found that marketing claims across 716 stem cell clinics in the U.S. were misleading and, in some cases, dangerous.
The problem is misunderstanding of what types of stem cells provide a platform for regenerating muscle or rebuilding organs. Stem cells derived from embryos have this ability, known as pluripotency. Adult stem cells do not have pluripotency, and to acquire pluripotency adult cells must be biologically reprogrammed. These induced pluripotent stem cells allow doctors to treat serious disease like leukemia and other cancers in the blood and bone marrow.
Fat-derived stem cell therapy uses mesenchymal stem cells found in fat, which have limited function and effectiveness.
The FDA is calling on clinics to prove the safety and efficacy of fat-derived stem cell treatments through rigorous clinical trials. To make this feasible for small businesses, the agency announced a streamlined clinical trial process, where clinics can team up on trials and pool their patients to save time and money.
The FDA is offering up to a 36-month grace period for clinics to comply with its guidelines. Clinics can continue to operate on patients without clinical trials for now, but the FDA is monitoring and warning patients to do their part to stay safe.
Practitioners performing these therapies argue that, even with the new process, clinical trials are expensive and can last for many years, which takes their attention away from patient care.
For integrative practitioners, the priority is the patient, but the obligation is to do no harm. Stem cell therapy sounds promising, but the research isn’t there to make sure therapies deliver on that promise. It is at the hands of practitioners conducting ethical, thorough clinical trials to make sure these innovative treatments are safe and effective.