Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson.
I want to start with a compelling narrative being told to 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 number of hematologic malignancies and hematologic 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 this study appearing in Stem Cell Reports,[1] 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.
As you can see here, the range of conditions being treated is incredibly broad, with inflammatory and orthopedic conditions topping the list.
From Frow EK, et al. Stem Cell Reports. 2019;13:1-7.
Who’s running these places? The majority are run by MDs, though there is a smattering of other providers, as you can see here.
From Frow EK, et al. Stem Cell Reports. 2019;13:1-7.
What raises my hackles a bit are the clinics where the training of the provider doesn’t match up with the services offered. It’s one thing for an orthopedic surgeon to offer stem cell injections into arthritic knees, but the authors documented clinics run by cosmetic surgeons offering treatment for lung disease and autism.
Are these clinicians providing cutting-edge treatments or is it a shameless cash grab? Maybe both? These treatments are not entirely benign. In 2017, several patients went blindafter 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 reinjected.
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 Hippocratic Oath to first do no harm. Can these providers honestly say that they are meeting that standard? Look, I’m not saying that stem cell therapies are modern-day snake oil. They really may work. But we don’t know if they work and we don’t fully understand the risks. Why are certain individuals — MDs — willing to expose patients to risks they don’t fully understand?
Well, I can think of about 5000 reasons.
