Over the years on a fairly regular basis I’ve been contacted by patients seeking information about stem cell treatments and stem cell clinics. Note that patients may want to check out my stem cell patient guide, which has key questions and advocates for a critical, skeptical view of these offerings.
But in 2012 the number of patients asking me about stem cell treatments and clinics has skyrocketed.
The emails and phone calls have markedly increased. Other stem cell scientists and people at legit stem cell companies are telling me the same thing:
Dramatically higher patient contacts.
I believe the strikingly higher number of patients reaching out mostly reflects (A) more dubious stem cell clinics and practitioners in (or from outside but tapping into) the American market and (B) a deeper penetrance in the American consciousness of stem cells as an alternative form of medicine.
When most people think of dubious treatments, what comes to their mind is patients traveling outside the U.S. for treatments, but I’m telling you more and more people are getting these treatments right here in the U.S. Others are getting the treatment outside the U.S., but are recruited inside the U.S.
I believe we’ve reached a dangerous, epidemic level of dubious treatments.
Why do I use that word “epidemic”? Because, the clinics I am referring to put patients in danger strictly for the goal of profit. They fly under the radar and do not engage with the FDA at all. These are not clinics or physicians that you hear about in the news or on this blog. Many have no clear track record in the stem cell field.
Some of these rogue clinics are highly sophisticated. Others are what I call “mom and pop” operations and it is not unusual for them to operate out of a strip mall. It seems the word has got out that a quick way to make some money is selling “stem cells” to vulnerable patients. It is a simple matter to find dozens of such clinics by searching the Internet.
Not only does this rapid growth in dubious clinics put patients directly at risk, but also collectively they strain the FDA, which is not staffed to keep up. I think we may now have crossed a dangerous tipping point I referred to a few months ago where the FDA simply no longer has the manpower to police all these clinics that together offer treatments for a wide range of ailments, cosmetic treatments, and sports medicine.
We are in danger of reaching the “whack-a-mole” point in the stem cell field, where action against one clinic seems almost futile as one or two more simply pop up elsewhere.
These rogue clinics and docs are a direct threat to not only the stem cell field as a whole, but also to legitimate stem cell operations that have engaged with the FDA and are trying to help patients.
What to do?
The stem cell community including scientists needs to step up to the plate and publicly do more to educate patients. Help from the mainstream media would also be appreciated.
Perhaps the FDA needs additional staffing or we need more action by the FBI or other legal authorities.
The clock is ticking. How many patients have to die?
Paul, it would be helpful for the media and the general population if “all stem cell therapies” would stop getting thrown in the same pot.
There is a huge difference in the risk profiles involved in these therapies. A clinic which is using embryonic vs. one who is using freshly SVF isolated cells in the same operative session are surely two different animals. The risk profile for embryonic, induced pluripotent, and adult stem cells therapies are very different. Why slather the word ‘dubious’ and ‘rogue’ across all ‘stem cell clinics’ worldwide? What about bone marrow transplants? That’s a stem cell therapy—are you saying that is rogue too? Do you see my point?
According to the clinicaltrials.gov database, many of these Adult Stem Cell indications have completed Phase I endpoints of safety and efficacy. Adult Stem Cells are in a completely different camp than embryonic and IPS. Why don’t you ever elaborate on that concept to your readers? While we all acknowledge it is the Wild West , there are trails being blazed.
Also, consider looking at things from the patient side. If you are a patient with no hope by traditional modern medicine , would you not consider Adult Stem Cell Therapy at on offshore clinic which was using therapeutic methodology from successful Phase I and Phase II trials?
Hi Leeza.
Thanks for the comment.
I’m not saying ALL treatments are dubious by any means.
However, perhaps a new post is in order on helping patients figure out how to tell the difference.
I do not advocate offshore treatments for any patients at this time, however I am respectful of patients who make that choice. If it were me in that situation, I really don’t know what I’d do, but I would sure have some hesitation about getting a non-approved stem cell treatment. You also have to keep in mind that the majority of offshore stem cell treatments are NOT based on any clinical trials whatsoever.
Paul–as a PhD blogger, you are in a great position to help patients and the media sort out the difference. I look forward to seeing more 🙂
FWIW, I made this Infographic on Stem Cell Types about a year ago . Please take a look and let me know if you have any suggestions for improvement.
http://www.cosmeticsurg.net/blog/2011/09/16/stem-cell-types/
Thanks for writing back!
@Leeza – does this clinic process lipo fat on site to get stem cells for face lifts? If so, which machine are they using? @Paul – Do you see potentially huge legal liabilities to US doctors performing “stem cell treatments” with machines in their offices that seem to be giving stem cell yields that are overestimated by up to 20 times? I am referring to the paper recently disseminated by Mary Pat Moyer in Texas. http://www.incell.com/INCELL%20Stem%20Cell%20Counting%20Methods%20Inaccurate%20Dosing.pdf Also, do you agree with plastic surgery outfits using stem cells for cosmetic treatments even when there is no scientific proof that that work any better than other treatments?
Legal liability is hard to gauge and I’m no lawyer, but in a general sense in the stem cell treatment field overall, I do think we will see more lawsuits even for businesses technically HQ’d outside the U.S.
On the other hand legitimate stem cell businesses doing clinical trials and working with the FDA should be commended and are likely, from a practical point of view, to face far less liability.
As I’ve said in the past, I do not endorse stem cell cosmetics or stem cell sports medicine.
@InTheKnow
My comment was made in a general context of SVF adult vs. embryonic.
However, as to your question, I am certain that there are some offshore clinics using freshly isolated adipose stem cells for either/both cosmetic and medical procedures. The are using manual methods and devices. Last year I met a Plastic Surgeon from Latvia who was using Cytori’s Celution and happy with results.
WRT your statement that there is no scientific proof of better results, I will tell you that I have seen scores of Investigators at IFATS conferences presenting very convincing data. The ASPS is getting very psyched about this entire field. They wrote a cautious, slightly negative position paper ~ year ago, but a lot of mileage has been driven since then. Stay tuned for happier times . While ASPS will certainly not be giving the green light yet (in the USA) because of the FDA, I expect a much more positive spin for the use of adipose SC for numerous indications.
As far as Intellicell…..micelles dressed up as stem cells….. many in the Plastic Surgery community have been highly skeptical of their reported yields from the beginning. Furthermore, the SEC has been on their trail for some time. This company was birthed out of a shell company, which had a series of name changes. Never a good sign. So happy to see Mary Pat’s paper clearing the air on this cell count thing!