I recently interviewed Drs. Elliot Lander and Mark Berman of the Cell Surgical Network, an affiliated chain of clinics selling stem cell interventions for more than a dozen medical conditions. You can read Part 1 here and Part 2 here of the interview where we cover 10 important questions.
Today is Part 3, where I explain why their answers deeply trouble me.
First, let me answer a question myself: why interview the leaders of the Cell Surgical Network, especially if I felt going into it that I would likely disagree with them on many things?
It is important to catalyze dialogue in the stem cell field; that is one of the missions of this blog. As I’ve said before, it is easy to talk to someone with whom you agree on most everything, but it is much harder and yet nonetheless probably more rewarding to dialogue with those with whom you disagree.
Further, I specifically see value in shedding light on how the Cell Surgical Network conducts stem cell interventions and on their views on the regulatory landscape.
Because they are a group of dozens of clinics (see their map above) potentially doing interventions on hundreds or thousands of patients collectively. I’m concerned about risks for those patients and possible future patients. Many physicians who are relative newbies to the stem cell field who are part of the Network could be putting their careers at risk too. Therefore another part of the rationale for this blog post series was educational.
One of the deepest differences that I have with Drs. Lander and Berman is related to my core belief in evidence-based medicine. I believe in having compelling pre-clinical evidence before you start to do a specific kind of new or experimental medicine on human patients. To my way of thinking, for example, prior to getting even one patient involved with an experimental medical approach you should do pre-clinical studies on animals for a given medical condition with the specific medical intervention in question. Then you collect data on safety and efficacy. If these studies are convincing to you, to regulators, and to your community (via peer review and publication) you start the process of possibly doing clinical studies in patients. To my knowledge this has not been the path taken by Cell Surgical Network. If I am mistaken about that, I hope that they correct me. Perhaps they do not define their interventions as experimental, but they are doing a clinical trial and to me at least their work seems like experimental clinical research.
Another concern pertains to whether Cell Surgical Network’s way of doing things would be considered compliant to the FDA. The Cell Surgical Network said the following of the FDA in the interview with me:
Finally, the FDA has audited our IRB approved protocol and there was never any communication indicating that it wasn’t appropriate. Out of the 29 protocols from the ICMS IRB reviewed, only one was rejected by the FDA (not ours). That, in itself, is an indication that we are not in any violation of FDA regulations.
My understanding is that the FDA audited the International Cellular Medicine Society (ICMS) in general. ICMS is an organization that administers a host of IRBs, only one of which was the Cell Surgical Network IRB at the time of the FDA audit. As a result, I disagree with the characterization that the recent FDA ICMS audit results are specifically an indication that the Cell Surgical Network is compliant with FDA regulations.
Another issue is the device used by the Network. As Alexey pointed out in the comments on an early part of this blog series on the Network, it seems the Medi-Khan column used by the Cell Surgical Network to make their biological SVF product is not approved by the FDA for that specific application. This could be a very serious problem.
The Cell Surgical Network also argues further that their SVF product is not laboratory prepared, but rather is surgically prepared and is hence not subject to FDA biological drug regs. I’m not convinced by that argument. The use of collagenase and then centrifugation of a fat product through a column would seem to me together to be a laboratory procedure. I believe that the FDA public guidance in this arena that is relevant to how the Cell Surgical Network prepares their product strongly indicates that it is in fact a biological drug as defined by FDA. This is a crucial point as to my knowledge the Cell Surgical Network does not have FDA approval to use a biological drug.
An additional problematic area in my view is the issue of homologous use. In this area, Lander and Berman seem to argue that their SVF product is a progenitor/stem cell like product that defies non-homologous use categorization because it can in essence turn into almost anything in the body due to its cellular potency. I don’t buy this argument. SVF contains a complex mixture of many components some of which are stem and progenitor cells, but it is nonetheless still an adipose derivative. In my opinion an adipose derivative is not pan-homologous to any other tissue such as the nervous system or many others for which the Cell Surgical Network treats many patients.
Regarding my question to Drs. Lander and Berman about patients having to pay the Network for participation in its clinical trials, I also philosophically disagree with them. I do not personally believe in collecting millions of dollars from patients for interventions that are still arguably, in my opinion, experimental.
I also am concerned with such a big group of clinics that the Network may be enabling inadequately trained physicians to conduct SVF-based therapies, potentially putting a large number of patients at risk. Physician training in stem cell and cellular medicine therapies is a top priority for me.
In the end, you can see I have many concerns about how Cell Surgical Network answered my questions and how they do interventions with patients. I welcome more dialogue with them and readers of this blog.
Disclaimer: the statements in this opinion piece are solely my views, not facts, and I certainly expect a spectrum of opinions on these important topics.