Recently, 570 stem cell clinics have popped up across the U.S. offering treatments for many health issues. From arthritis to spinal cord injuries to autism, the clinics are claiming stem cells from various body tissues can solve your health problems.
But stem cell researchers say these claims can’t be supported with proper evidence. George Daley, a stem cell researcher at Harvard, says there’s “a lot of sketchy stuff” happening at these clinics and raises concerns about the safety and efficacy of these treatments.
Stem cells and the FDA, so far
As of now, the Food and Drug Administration hasn’t been actively regulating stem cell clinics – because generally the clinics are using cells from the same person (autologuous transplant), and aren’t processed before injection. So far, the FDA has only approved one stem cell product: Hemacord therapy, which helps patients with blood disorders improve their low blood count.
But because the clinics are opening at rapid speed and offering a wide variety of treatments, the FDA has begun consideration for more active regulation of stem cells. Just two weeks ago, the FDA held a two-day public hearing at the National Institutes of Health in Maryland for the discussion of stem cell regulation with the input of the public, including doctors, business owners, researchers and patients – input can still be submitted through today. While some are asking the FDA to loosen restrictions so patients can access the treatments, others are demanding the FDA to crack down and penalize clinics who use unproven stem cell therapies.
The problem with unproven therapies
Daley says the clinics are taking stem cells and injecting them into people’s joints, spinal cords and brains and making claims that can’t be backed up by current research. The treatments can cause infections that could turn deadly, create tumors or cause the patient’s immune system to react dangerously. And these treatments cost thousands of dollars and aren’t covered by insurance.
For a long time doctors have already been using stem cells from bone marrow and blood to successfully treat some types of cancer including leukemia and lymphoma. Stem cells are also currently studied to be used as potential cures to health issues – replacing damaged cells, tissues and organs. But only a few have been deemed effective and safe.
Can further research prevent malpractice?
The FDA approval process is a long one, and includes rounds of clinical trials for safety, efficacy and finally a larger sample of patients to prove its widespread usefulness. Some stem cell proponents complain that the process takes too long, while others believe the more research and testing on the subject, the better. As long as the clinics are open, there must be an effective way to avoid malpractice and further harm to those seeking treatment for their maladies.