To stem cell clinics: do your homework & take FDA “current thinking” seriously

FDA draft guidanceOne of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog.

  • What does a warning letter really mean? What triggers it?
  • Why do some businesses selling stem cells get inspected and others don’t?
  • What do some entities get warning letters over the years, while others don’t?
  • What weight does a draft guideline have?
  • How about a finalized one?
  • If a business disagrees with an FDA guideline or action, what should it do?
  • If a business operates without FDA approval (maybe because they disagree with the FDA) when it seems that it should need that approval and yet the FDA takes no action, does that mean anything?

The list goes on and on.

It’s kind of like trying to read tealeaves. One of the FDA reforms I advocated for in my book, Stem Cells: An Insider’s Guide, is more clarity and better communication.

Despite the many questions and confusion out there, I would say one thing is clear: Take FDA “current thinking” very seriously.

While current thinking as articulated in guidances (draft or otherwise) is not formally equivalent to a regulation, it would seem to have the power to trigger action based on the historical record.

Therefore, one broader lesson in this arena would seem to be that the FDA can pull the trigger on actions like visits and warning letters based on their current thinking even if that current thinking is not formally crystalized beyond draft guidances or even without any draft guidances. For instance, it seems pretty clear that the FDA right now views SVF as a drug and while it may not have done much about this action wise yet, the odds are that such action will be coming sooner or later. The same goes for non-homologous use of bone marrow and amniotic stem cells such as for neurologic conditions. In other words, what the FDA staff think is going to be their basis for actions. SVF

As a result, it kind of goes both ways in the sense that guidances (draft or otherwise) are not formal regulations and “only” reflect current FDA thinking, but at the same time “FDA current thinking” shouldn’t be underestimated in terms of importance as it clearly can play a big role as the basis for action.

Too often I’ve heard clinics or other advocates say things like, “these are just draft guidelines” or “the FDA hasn’t been clear on that yet”. The reality is that no matter what any of us might like (e.g. increased FDA clarity), it is not the FDA’s responsibility to make sure everything is crystal clear for every stem cell clinic out there. Rather, it is the physicians’ responsibility to do their homework on the FDA and all relevant regulations, current thinking, etc.

If a clinic wants to challenge the FDA I can respect that if it is done responsibly, but it is a very different matter and a risky game to do such a challenge operationally by administering what by all accounts the FDA considers to be unapproved drugs into patients and then waiting to see if anything happens on the regulatory front.

This game of stem cell chicken is particularly risky if you are “treating” medical conditions outside of your specialty and do not have any rigorous training in stem cells as well as having little if any expertise in FDA regulatory affairs. And, no, a weekend resort or other similar quickie “course” on stem cells doesn’t really count.

New stem cell clinic ‘National Institutes for Regenerative Medicine’ has NIH-like name, cites UCSD affiliation

National IRMSome 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?Jon Wilensky

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.