Can you believe it? There are 600 clinics across the United States that provide stem cell treatments! Claiming they’ll fix your spinal cord break, Parkinson’s disease, Alzheimer’s, and ALS, among other ailments.
Except that stem cell research in the US is illegal. Oh, sure, we can induce some skin cells (which are, indeed, a stem cell of sorts), but they are not derived from embryos, whose stem cells can mature into any human cell. (Note: Bone marrow, which we’ve been transplanting forever, has stem cells that can burgeon into fat, tendon, cartilage, or bone cells.)
Oh, and these clinics are not covered by insurance. And, are operating using a loophole in the law- since neither the therapy nor the clinics themselves are approved by the US Food and Drug Administration.
What’s the loophole? The patient’s own skin stem cells (actually, liposuction is performed, where the removed fat contains some stem cells) are harvested and used for the therapy. (Of course, there is some “minimal manipulation”. Sure. That’s what makes it a medical procedure and not a drug treatment.)
Here’s how the process works. The harvested cells are spun in a centrifuge, which separates the adipose-derived stem cells from the other tissues removed from the body. The separated cells are then injected directly to the patient’s joints, tendons, or ligaments- or infused back into the body via iv (intravenous injection).
Given the results I mentioned above, it’s pretty clear that there also is a question of whether the therapy works. It’s also not clear that all these stem cell clinics actually can or do produce stem cells. And, if the patient demonstrates improvement- is it a placebo effect? After all, the patient just forked over some $ 5 to $ 20K to the clinic- it wants it to succeed. (Remember those commercials- “It is live or is it Memorex”?)
And, at least two patients have died after experiencing these “stem cell treatments”. One woman, desperate for a younger appearance, was rewarded by having bone growth in her eyelids. (Yes, the stem cells formed new bone there!) Others have gone blind while hoping to allevite their macular degeneration condition. (This latter “therapy” was termed a “clinical trial”- except no responsible authority was monitoring the regimen.)
If you really think someone is performing a clinical trial, don’t take their word for it. Look up the site www.clinicaltrials.gov (which ahs been around for almost 20 years now) to see what’s what. (Note: There are more than a dozen unregulated clinical trials listed in the database. Read the list carefully! And, note further that most clinical trials are free to participants; if you’re being charged, it’s probably not a true clinical trial and it’s also probably unregulated.)
Mark Berman, MD, started his chain of clinics (Cell Surgical Network) about 15 years ago. He claims they’ve effected some 5000 such treatments (including work he performed on his wife and himself). And, there are some tantalizing results, for those stem cell therapies that are applied to stroke and MS patients, even a few for Parkinson’s. But, those studies are being done at universities- and under clinical trial guidelines.
Finally, the FDA is developing rules for governance now. (Dr. Scott Gottlieb, FDA Director, has called this a “roadmap” approach. ) Plus, the FDA has dealt with StemImmune (US Marshals raided the San Diego clinic) and US Stem Cell Clinic of Sunrise (FL) for their unapproved stem cell treatments.
But, the FDA also knows that many university-based trials are needed- and doesn’t want to block the therapies for which we all hope.
Now, if you really want to find out a lot more about stem cells and stem clinics…you should check out The Niche. (That’s the name of the blog, but it’s address is https://ipscell.com/ . ) This site is the creation of Dr. Paul Knoepfler, a scientist working at Shriner’s Hospital and UC Davis. He’s a good choice upon whom to rely for more information about these “stem cell clinics”. Until the FDA issues their rules for governance.
Let’s hope the “roadmap” is provided soon.
