Is 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.