Cell Surgical Network, largest group of US clinics, using lab-expanded stem cells in patients?

Elliot Lander Mark BermanIs the largest affiliated group of stem cell clinics in America, Cell Surgical Network, now using laboratory-proliferated stem cells in patients?

Do they already have some kind of final FDA approval for this clinical approach given that lab-grown stem cells are generally viewed as drugs requiring premarket approval?

Over the years I’ve reached out to interview many members of our diverse community in the stem cell arena including those operating stem cell clinics. One past such past interview (here and here) was with the leaders of Cell Surgical Network, Drs. Mark Berman and Elliot Lander.

Even though more broadly those operating stem cell clinics across the U.S. and I don’t see eye to eye on many things, the interviews are valuable to the community, providing insights generally not otherwise found in the public domain.

Today’s post is a new, striking interview with Lander and Berman (pictured above). I invited them to do this short Q&A because there have been indications that their group of clinics may be gearing up to or already has been taking a different approach (at least compared to what I knew about in the past) to using stem cells in patients with the possible new approach involving laboratory-amplified stem cells.

For instance, on their website FAQ page they refer to using seemingly laboratory expanded cells (emphasis mine):

“Autologous lipo-aspirate can be frozen as SVF Stromal Vascular Fraction (contains mesenchymal and hematopoetic stem cells). SVF can be deployed for repeated treatments and also expanded under IRB approval as part of a safety trial providing vast quantities of autologous stem cells that could be used throughout that patient’s life.”

The question of lab expansion is such a crucial point because to my knowledge lab-expanded stem cells are considered a biological drug by the FDA requiring pre-market approval steps such as an IND, IDE, and/or BLA. Also, typically a safety trial of the type mentioned would be an FDA-approved, Phase I clinical trial based on an IND and I’m not aware of Cell Surgical Network having that.

To my knowledge, IRB approval alone is not a sufficient basis for doing a clinical trial on a biologic. Am I missing something here? Is Cell Surgical Network’s apparent IDE application with the FDA going to encompass data usually found in an IND as well? Why not do an IND and an IDE In this case?

The point of this interview was to try to clarify this situation. Thanks, to Berman and Lander  of CSN for doing it.

PK: I’m hearing that you are apparently growing adipose stem cells in the lab these days for clinical use (transplantation) in patients. Is that correct?

CSN: Yes – Our patients receive re-implantation (not transplantation) of their own cells under this protocol. 

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Popular Science stem cell clinic article itself raising some red flags

Popular Science stem cellsPopular Science recently did a piece on stem cell clinics that has raised some red flags. The concerns in this case are not necessarily about the clinics per se, but rather the actual article itself.

There are a lot of stem cell clinics out there and for years they had a pretty consistent strategy of avoiding media attention. It’s almost as if they had a secret “fly under the radar” club to avoid negative PR.

However, today’s stem cell clinics are bolder and have adopted a new strategy: actively use the media as a tool for positive PR.

For instance, there is the Gordie Howe-Stemedica case that seems to keep on giving and giving PR to Stemedica and its Mexican partner Novastem. Amongst other things, they do some non-FDA approved stem cell interventions in Mexico. After months of positive PR on the Howe story for Stemedica including from Howe’s family who talked up the clinic, we all learned that the Howe family had become investors in Stemedica at some point.

Popular Science has, in my way of thinking, fallen into this kind of stem cell clinic PR web with a recent piece. Writer Tyler Graham worked for a long time on this story on stem cell clinic chain, Cell Surgical Network (CSN). During that time he contacted Leigh Turner and me for assistance on the story and quotes.

Tyler also became, by his own disclosure in his piece in Popular Science, a patient of CSN, but we were not made aware of that. Tyler reports in his article having got a therapy from CSN doctor Mark Berman for a long-term, very troublesome back condition and gives a remarkable account of how the treatment apparently helped him. A cure is suggested.

Then there is the title of the piece: THE CURE-ALL.

There is no question mark on that title and the implication in the article is that the writer was cured of his back problem by CSN. The net result of this article is likely a drive of new business to CSN.

To his credit, Tyler does raise numerous questions about stem cell clinic offerings. He also reports on another patient (Lamon Brewster) who in the long run was not helped by CSN so that part of the article is good for balance, but overall my sense is that the article is very problematic.

The piece has some statements that sound promotional:

“That’s not to say Berman is doing anything illegal by offering a treatment he doesn’t fully comprehend. He’s not. He’s not even doing anything unethical. He is healing patients who could not be healed.”

These statements are questionable.

In the end this article is a big disappointment.

Because some high profile people have received free treatment (e.g. Gordie Howe) from stem cell clinics I asked Tyler if he received any kind of discount, free treatment, or other benefit from Dr. Berman or CSN, but got no reply. I also asked the fact checker for this story, Rebecca Geiger, about this question, but she did not reply either.

If I do hear from them I will definitely post it. It could well be that full price was paid and there were no other perks, but it was a reasonable question to ask.

If you want to see a recent in my view more balanced, investigative piece of journalism on stem cell clinics, I’d recommend taking a look at the great piece by the Associated Press (AP) by Matt Perrone.

Update on Cell Surgical Network IRB Status

Cell Surgical NetworkThe Cell Surgical Network is a for-profit network of clinics offering various stem cell-related interventions, which began with the California Stem Cell Treatment Center.

I have interviewed Drs. Elliot Lander and Mark Berman of Cell Surgical Network in past (Part 1, Part 2) and I raised some concerns about the network in a follow up Part 3 post, which was replied to in a lengthy comment by Dr. Berman. In the course of this dialogue it was indicated that Cell Surgical Network had an IRB through the International Cellular Medicine Society (ICMS).

The point of today’s blog post is to provide an update on the IRB situation.

Cell Surgical Network has informed me that the ICMS IRB has been cancelled.

Drs. Berman and Lander now have some IRBs through a different organization, the International Cell Surgical Society (ICSS).