Stem cells for sale.
What you need to know before going under the needle.
Stem cell clinics are popping up across the US touting a cure for everything from back pain to aging. Here are the facts to help you make an informed decision.
Just after Christmas I pulled this from my mailbox:
I couldn’t tell who it was from, but I was overdue for a nice dinner. Inside I found an invitation from a regenerative medicine clinic, screaming: “Isn’t it time you found a real solution for your pain?” I wasn’t in pain. But my recent binge-listening of the Bad Batch podcast and quality of food from the host restaurant spurred me to attend.
What I learned as I dined was that there are a lot of nuances to stem cell therapy.
“Stem cells” is a catch-all term
Stem cell transplants have been performed since at least the 1950’s to treat specific blood and lymphatic disorders. Over the decades stem cells have been studied for their potential to treat these conditions and more. Stem cell treatments vary in the source of starting material, how and where they are processed, among other factors.
In adults, stem cells are present in blood, bone marrow, and adipose tissue. After the cells are collected, they are often grown outside the body to amplify their numbers. The processed cells are injected back into the same person, perhaps into a damaged knee.
Umbilical cords donated after a baby’s birth are a common source of stem cells. As I enjoyed a crisp winter salad at the seminar venue, Jim, the retired chemical engineer leading the talk, said that’s what the clinic uses. The stem cells come from a part called Wharton’s jelly, and some extra steps are done to isolate smaller components called exosomes.
Few treatments are approved
Only a handful of treatments are approved by the US regulatory authorities, the Food and Drug Administration (FDA). They are used to treat specific blood cancers and other blood disorders. These treatments have gone through the FDA’s process, which typically takes years and checks that drugs are safe for people and effective for the specific condition they’re stated to treat.
Early in his marketing spiel, Jim told the 20 or so middle-aged folks crammed around six tables in a small room that the clinic’s stem cell treatments are not FDA approved. And a discerning eye could spot the disclaimers at the bottom of the brochure we received, under rows of quotes from satisfied customers.
Testimonials are not objective evidence
The talk was peppered with short video testimonials on how the treatments changed people’s lives for the better. Over the entrée course Jim shared his own testimonial and one for his wife, an Alzheimer’s patient who could now feed herself.
The risks might be more than you bargained for
Regardless of the starting material, there are many steps between collection and treatment. Microbes such as bacteria can enter the sample at steps that are not controlled tightly to prevent this. Processing might occur at different places, possibly even outside the US. At any point in the journey, the cells can die and thus become inactive.
No treatment is risk-free, but those approved by the FDA have been checked for safety and efficacy and have gone through a rigorous process backed by scientific data. They are made under stringent controls according to the paperwork the manufacturer has filed with the FDA. The company I work for, Cytiva, supports cell therapy manufacturers with equipment and services.
If the treatment you’re considering isn’t FDA approved, check to see if the FDA has granted it an Investigational New Drug (IND) application or if the operation facility has registered with the FDA. This allows patients to enroll in a study under clinical study guidelines.
If the treatment isn’t on either of these lists, the risks go up. Possible adverse reactions are infection, tumors, vision loss, and even death. Chances are that the treatment simply won’t work.
Several times during the seminar Jim mentioned minor side effects and stated that treatments don’t work in a predictable way. Looking back at the invitation, I noticed both disclaimers at the bottom.
As we inhaled a chocolate confection, Jim finally got down to dollars and cents. The clinic offers several treatment packages for thousands of dollars, which, unsurprisingly, are not covered by insurance.
Resources:
National Institutes of Health. Stem cell basics. https://stemcells.nih.gov/info/basics/1.htm Accessed 6 April 2020.
Mayo Clinic. Stem cells: What they are and what they do. https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117 Accessed 6 April 2020.
International Society for Stem Cell Research. Nine things to know about stem cell treatments. https://www.closerlookatstemcells.org/stem-cells-medicine/nine-things-to-know-about-stem-cell-treatments/ Accessed 6 April 2020.
Schroeder, M. O. Before you undergo stem cell treatment. US News and World Report. https://health.usnews.com/conditions/articles/before-you-undergo-stem-cell-treatment Accessed 6 April 2020.
