OK. For the past two days, we spoke about STEM.  That’s science, technology, engineering, and mathematics.  (Here are the links to Monday’s and Friday’s posts.)  Today, we’re switching gears to a different stem- stem cell therapy.  And, we’ll stay on this topic for a day or two.  (I hope to keep you engaged, too!)

I really can’t believe that there are somewhere between 600 and 700 clinics across the United States that provide stem cell treatments.  Claiming they’ll fix your spinal cord break, Parkinson’s disease, Alzheimer’s, even ALS (Amyotrophic Lateral Sclerosis, aka Lou Gherig’s disease).

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- given that the therapy and the clinics are not approved by the US Food and Drug Administration.

What’s the loophole?  The patient’s own skin stem cells (actually, liposuction is performed, recovering the removed fat which contains the stem cells) are harvested and used for the therapy. (Of course, there has been but “minimal manipulation”.  Sure. That’s what makes it a medical procedure and not a drug treatment.)

Here’s how the process works.  The removed fat cells are spun in a centrifuge, which separates the adipose-derived stem cells from the other tissues removed from the body.  The separated cells (after the manipulations listed in the diagram above) 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? Especially if the patient forked over some $ 5 to $ 20K to the clinic?  (Remember those commercials?  It is live or is it Memorex?)

So far, at least two patients have died.  Another patient, a woman, desperate for a younger appearance, was rewarded by having bone growth in her eyelids.  (Yes, the stem cells formed new bone!)  Others have gone blind while hoping to alleviate 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 www.clinicaltrials.gov (this has 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.)

There are some tantalizing results when bona fide stem cells are used to treat stroke or MS patients.  That’s why 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).

Given these controversial results, the FDA is developing rules for governance now. (Dr. Scott Gottlieb, FDA Director, has called this a “roadmap”  approach.   And, they’ve 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 have been working to provide the therapies for which we all hope.  Using pluripotent stem cells,  which have the potential to be almost as good as the embryonic variety.

Let’s hope the “roadmap” is provided soon.