In 2016, the Food and Drug Administration brought to the public’s attention a growing issue across the nation— experimental stem cell clinics. These for-profit clinics offer stem cell therapies with the claim of curing anything from COVID-19 and Alzheimer’s to hair loss and aging. Currently, there are nearly 1,500 businesses with 3,000 clinics across the country that offer unapproved stem cell treatments.
Stem cell technology has real potential to bring forth a new age of medicine. Research has shown promising results for stem cells as a treatment for many of the diseases that these clinics hope to cure. However, the process of creating a new drug or medical treatment that is safe and effective requires many years of experimentation and clinical trials before approval. As of now, the only stem cell therapy that has been approved for clinical application is the use of bone marrow or blood stem cells as blood marrow replacements for patients with cancer.
The vast majority of clinics currently advertising stem cell treatments are not approved by the FDA, are unaccredited, and are not reimbursed by insurance.
In addition, these new clinics divert patients away from participating in clinical trials. This severely hinders stem cell therapies from becoming approved as official medical procedures. Instead, patients who have pain, discomfort, or who have serious illnesses pay up to $25,000 out of pocket to receive experimental therapies that can have serious unpredicted risks. Already, there are reports of patients who have died after receiving these stem cell injections. Another woman developed painful bone fragments in her eyelids after undergoing treatment.
At first glance, there do not seem to be many adverse reactions to stem cell treatments that have actually been reported to the FDA. However, attempts to comprehensively track the number of injuries caused by these treatments seem to suggest that harm done to patients tends to go unreported by these clinics. Research conducted by the non-profit organization, PEW Charitable Trusts, found that by 2019 at least 360 people had experienced serious infections, lifelong disabilities, or death.
These risks led to an attempt to regulate stem cell clinics. In 2017, the FDA sent a warning letter to a network of clinics across the nation. The letter stated that stem cells were a drug. Clinics were now required to prove that their therapies were safe and effective. This would allow them to achieve FDA licenses to continue their operations. The clinics were given two and a half years to do so.
Unfortunately, what began as a policy to restrict the availability of unregulated stem cell procedures, ended up being seen as a green light for many other stem cell businesses to open. In the last five years, according to a study conducted by UC Irvine’s Dr. Leigh Turner, the number of unapproved stem cell therapy clinics has increased dramatically. Based on Turner’s counts, the number of clinics has jumped from 600 in 2016 to almost 3,000.
In support of public access to these experimental stem cell treatments, several clinics and businesses reference federal and state legislation to argue that individual choice should be respected and that the FDA should not be involved in regulating the clinics. However, with the recent expansion of these businesses and the unknown risks to vulnerable patients, there is certainly a substantial argument to increase regulations and enforce reports of patient outcomes so that more data can be collected on the effects of these clinics.
As always, where the boundaries lie between individual rights and government control in medical progress is a tricky subject. The question that now remains is what regulations should exist and more importantly, what regulations can?