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.
PK: Any comment about the change in your practices?
CSN: Our practice has remained fundamentally the same and is based on the investigative studies of safety and efficacy for surgical deployment of autologous adipose derived cells. We function under IRB (with FWA) and we follow all outcomes on our online database. This database was used to help us publish our initial peer reviewed experience on 1524 patients and will be printed in the March issue of American Journal of Cosmetic Surgery. We had two other publications in the past year as well. One of our IRB approved safety studies includes expansion (in an FDA registered cryobank) of MSC’s derived from autologous SVF on 100 patients. While currently under investigational studies, these cells can be saved for possible use to potentially mitigate a number of degenerative conditions. We are simultaneously preparing an IDE application for the cryobank process but want to compile reasonable safety and outcomes data before filing. We also need to complete our “IDE for point of care” application as a prerequisite to that application. This is a fairly tedious process and we’ve been working with the FDA for the last year and a half and are nearly complete in our tasks to get approval.
We included information on that study for our sub- investigators in an educational webinar that was attended by a number of interested parties including an “outraged” competitive regenerative medicine group that moved their cell production and manufacturing offshore to avoid the financial and logistical difficulties of doing such studies in the US as a predicate to an FDA IDE application.
PK: Thoughts on how the FDA will react?
CSN: We believe the FDA supports clinical research and the rigorous collection of data and the quality control applied in the IRB studies we are doing since much of the information we have collected will be and has already been submitted to the FDA as part of an IDE application related to our arthritis work.
PK: Do you or your other business partners have an IND? A BLA?
PK: If not, why not?
CSN: Once we determine safety and efficacy, and which claims we wish to pursue, then we will be able to work with regulators to find the best way to help patients obtain access to their own cells stored or expanded under sterile conditions.
PK: What about the whole FDA v. Regenerative Sciences case?
CSN: Honestly? We’d be willing to informally discuss this over the phone. We know a lot about the situation, but prefer not to “litigate” it in a blog.
PK: Anything else you want to add?
CSN: Domestic autologous cell banking appears to be an economic threat to competing point of care technologies and even to certain pharmacologic industries. All we care about is our patients. Providing them with the best and safest regenerative medical care in the world is what Americans deserve. We are not interested in anyone who desires to slow or obstruct this patient care by manipulating regulators into criminalizing certain medical practices. Therefore, we continue on our mission and ignore the fake news and rumors that generate blog ratings and spread fear and mistrust.