The issues with regulation of autologous adult stem cells (AASC) have caused a lot of discussions this year. This is, probably, the most difficult part of cell therapies regulation. There are many different opinions, groups and organizations, which lobby some interests. Unfortunatelly, the problem is still far from resolution and clarity. This summer I was trying to investigate the current trends and attitudes of professionals about these issues. One of the tools that I used was polling of professionals on LinkedIn. Today I’d like to share the results of these polls.
I chose LinkedIn group “Stem Cell Research” (you should have a LinkedIn profile in order to see it), because (i) it’s the largest group among stem cell/ cell therapy professionals (>5k members), (ii) the most representative group with great variety of stakeholders (stem cell researchers, cell therapy industry, cell manufacturers, stem cell research industry, physicians, patients and advocates). I thought that this group would be less biased in opinions and would provide the “most real picture” of current trends. I’ve asked 5 questions. You can see my own vote labeled orange.
I was curious what professionals think of “evidence for efficacy”. This question came up, because some folks think that in case of AASC, we don’t need clinical trials at all. In this case, when can we tell a patient that “treatment is efficacious”? As you can see the vast majority of professionals think we need to do all phases of clinical trials in order to conclude the efficacy.
If AASC will be regulated as “practice of medicine”, what about cell processing/ handling/ expansion (manufacturing) part? Should at least manufacturing part be regulated by FDA? The vast majority of professionals said “YES”.
If AASC could be potentially regulated as “practice of medicine”, why should we bother with GMP-grade manufacturing facilities? It’s very expensive and highly regulated. Could it be just GTP standard? Well, all voters think that we must to manufacture it under drugs/ biologics standard.
What is the best strategy to communicate with FDA about your AASC-based product? I was trying to highlight 3 ways of dealing with FDA – collaborate/ educate, fight and bypass the agency. Under the “fight” I meant an attempt to prove on a court that FDA has no jurisdiction of regulating AASC. Under “bypass” I meant an attempt for some independent autonomous regulation without intensive communication with federal agency. Based on recent comment, I have to make the correction – ICMS doesn’t aim to bypass FDA, but looking for a dialogue. So, as most of us would expect, an open dialogue and education of FDA is a way to go.
The last question caused some sharp difference in opinions. It was close to 50/50. Some folks are proposing to skip the phase 3 of trials, due to high cost and long duration. As you can see, I voted in favor of this proposal. I’d write about it in some time later.
Conclusions and discussion:
Based on very recent discussions in a few LinkedIn groups, I’d speculate that the voice of folks proposing AASC as a “practice of medicine” is getting stronger. But still, they are minority. There is some middle ground that I was trying to tease in my questions. For example, regulate AASC as “practice of medicine” without trials, but regulate manufacturing part and accredit facilities or do trials, but skip last phase.
As you can see the activity of LinkedIn group was very low. My polls were able to yield only 14-37 votes out of 5000-6000 possible. Unfortunately, this is very typical thing for LinkedIn professional groups. Nonetheless, I think, I collected votes of the most active professionals and advocates, who really care. Based on some discussions under the polls, I’d speculate that I was able to collect variety of opinions. So, I think, these results nicely represent the current trends.
My questions were not perfect, but it was probably the best that I was able to think of few months ago. I aimed to satisfy my interest, identify some trends and share it for public discussion. Because the LinkedIn group is private, I’d invite you to discuss these issues publicly here. Some questions facilitated discussions and I learn a lot from it. I hope this information will help you to get a sense of current debate about AASC regulation issues.