A compelling narrative is being told to many patients across the country. It goes like this: We physicians are going to use cutting-edge science to unlock the healing potential of your own cells to treat your chronic medical conditions. Sounds amazing, right? And it can all be yours for just about $5000 per treatment.
I’m talking about stem cell therapy. Stem cells are cells with the potential to differentiate into a variety of other cells or tissues. And to date, the FDA has approved their use in a limited number of hematologic (blood cell) malignancies and genetic conditions—and that’s it.
Stem cells are not FDA-approved for joint pain, cataracts, depression, autism, dementia, or heart disease, and yet hundreds of stem cell clinics around the country are offering them for these very conditions, as shown in a recent study appearing in Stem Cell Reports, which documented the activities of 169 stem cell businesses in the United States.
These for-profit companies charge patients thousands of dollars for unproven treatments. Patients bear the brunt of the costs, as most insurance companies won’t cover the therapies.
Up until recently, this was basically unregulated, though the FDA has started to change that.
The Stem Cell Reports study characterized 169 stem cell clinics in the Southwestern United States to systematically measure just what they are selling and who is running them.
The number of conditions being treated is incredibly large, with inflammatory and orthopedic conditions topping the list that include various kinds of arthritis, but also containing a Hodgepodge of other problems.
In March 2021, 1,480 U.S. businesses operating 2,754 clinics were selling purported stem-cell treatments for various indications. More than four times as many businesses than were identified five years ago are selling stem-cell products that are not FDA-approved and lack convincing evidence of safety and efficacy. The conditions these treatments most commonly claimed to treat were: pain (85%), orthopedic conditions (47%), sports injuries (23%), neurological diseases (9%), immunological conditions (8%), cosmetic problems (8%), hair loss (7%), lung and respiratory conditions (6%), erectile dysfunction and other sex-related conditions (6%), skin conditions and wounds (6%), cardiovascular diseases and conditions (6%), aging (6%), diabetes (2%), spinal cord injury or paralysis (2%), and vision loss or impairment (2%).
Only 56 of the businesses listed prices for services on their websites. The prices ranged from $1,200 to $28,000 with an average price of $5,118 and a median price of $4,000.
So you might ask “Who’s running these places?” The majority, sadly, are run by MDs, though there is a smattering of other providers with or without proper credentials. Unfortunately many of these so-called “clinics” offer a provider who is not trained for the services offered. It’s one thing for an orthopedic surgeon to offer stem cell injections into arthritic knees, but some “clinics” are run by others offering treatment for lung disease and autism. Are these “practitioners” providing cutting-edge treatments or is it a shameless cash grab? Maybe both?
These treatments are not entirely benign. In 2017, several patients went blind after their own adipose-derived stem cells were injected into their eyes. Infection remains a risk as well, as the cells are removed from the body, processed, and re-injected.
There is a reason that we demand well-conducted, randomized clinical trials before we embrace new therapies. In no small part, it’s to ensure that we are abiding by our primary and sacred oath to first do no harm. Can these providers honestly say that they are meeting that standard?
The possibility of increased enforcement activity by the FDA does not appear to have deterred most of the businesses identified in this study from continuing to market purported stem cell therapies. Rather, a review of their activities following the end of enforcement discretion reveals that most of them are still selling such products. Furthermore, additional businesses and clinics are entering the marketplace. This trend seems likely to continue absent substantial increases in enforcement activity by FDA, FTC, and other regulatory bodies and law enforcement agencies. Whether such regulatory action will occur now that the FDA’s era of enforcement discretion has ended is uncertain.