Some American stem cell clinics that operate without FDA approval can give the appearance of being in the mainstream of academic stem cell research.
Sometimes they go a step further to hint at or even say that they have some kind of federal approval as we saw in the past with the Stem.md website.
Why do this?
Broadly from a stem cell clinic perspective these efforts might pay financial dividends because patients trust the clinics more as a result.
For example, some stem cell clinics tout their listings on ClinicalTrials.gov as somehow meaning that their for-profit stem cell “treatments” are FDA- or NIH-approved, which they mostly aren’t. At the same time the clinics when pressed generally assert that they do not need any FDA or other approvals.
The specific names of the clinics and their affiliated organizations are important too for sounding authoritative. A stem cell clinic that just recently popped up really takes the cake on this front with its name: National Institutes for Regenerative Medicine.
Now as you read that name, don’t you think of the National Institutes of Health (NIH) or some other US governmental body?
It seems so similar. The clinic refers to itself by the shorter name “National IRM” too.
As far as I can tell the National IRM has nothing to do with NIH or even the now defunct NIH Center for Regenerative Medicine, which used to be the part of NIH that specifically had to do with regenerative medicine.
Instead, National IRM is an affiliate of Cell Surgical Network, potentially the largest chain of stem cell clinics operating in the US and notably one without FDA approval for their stem cell product (SVF) that I am aware of to date.
National IRM, headed by Dr. Jon Wilensky, seems to be focused on Southern California now. They are offering free seminars (emphasis mine):
In an effort to reach Southern California residents seeking a solution to chronic, arthritic pain, Dr. Jon Wilensky and The National IRM partnered with Omni La Costa Resort and Spa to offer monthly, complimentary seminars to educate the public on the revolution of stem cell therapy and how this state-of-the-art treatment can help improve longevity and quality of life for candidates suffering from common, joint related conditions, or who may be considering elective surgery due to injury or arthritis.
These sure sound like infomercials. The claim of lengthening life does not seem based on concrete evidence.
Who is Dr. Wilensky? He’s a plastic surgeon. On the National IRM seminar website, Dr. Wilensky also indicates that he is a clinical professor at UCSD Health System:
“Dr. Wilensky is Clinical Assistant Professor at the University of California-San Diego (UCSD) Health System and Chief Medical Officer of the National Institutes for Regenerative Medicine. He is revolutionizing the applications of Adipose-Derived Stem Cell therapy.”
For clarity on this and to ask what department he is affiliated with, I contacted Dr. Wilensky to ask some questions, but so far have gotten no reply. I did manage to talk to his PR person on the phone, but she didn’t seem to know the answers to my questions including the nature of the UCSD affiliation. She promised to arrange an interview with Wilensky, but has since not replied to emails. Stay tuned.
Update: Hat tip to reader who pointed out the following statement from the National IRM Website that kind of suggests some level of awareness on their part that they might be operating near the edge:
“ATTENTION: If you have ANY concern with our autologous stem cell treatment product, methods, website, or technique and think we may be violating any U.S. law, please contact us so that we can investigate the matter or concern immediately.”
Another query comes to mind. Why is Wilensky, a plastic surgeon, possibly treating orthopedic conditions like arthritis? I’m not sure.
On the bottom of the National IRM website it says this:
“National IRM is an Institutional Review Board (IRB) Approved Research Network. National IRM affiliated with the Cell Surgical Network for the investigational use of SVF for degenerative conditions.. National IRM’s surgeons are certified by the American Board of Plastic Surgery & American Board of Orthopaedic Surgery. For the investigational use of Adipose Derived Stem Cells (ADSC’s) for clinical research and deployment.”
As has frequently been discussed on this website, SVF seems to be currently viewed by the FDA as a biological drug requiring FDA licensing and approval in advance of use in patients, which again to my knowledge Cell Surgical Network does not currently have. In previous communication with Cell Surgical Network they have consistently argued that they are not subject to FDA oversight and their SVF product is not a drug. To date to my knowledge the FDA has never taken any action related to Cell Surgical Network.
The birth of National IRM is a further indication of how we are seeing blurred lines between the different players in the stem cell world.