Top 10 reasons for optimism on Stem Cell Awareness Day 2016

Happy Stem Cell Day!

It is a tumultuous time for the stem cell and regenerative medicine fields, but despite this there are concrete reasons for optimism on this Stem Cell Awareness Day. I’ve listed my top 10 below. What else gives you a sense of optimism? You can also check out CIRM’s nifty stem cell awareness day page too, from which I borrowed the below image.stem-cell-awareness-day-2016

  1. More trials = road to progress. There are more real, robust clinical trials than ever and they are progressing past the early phases in some cases. The trials are piling up and while not all will succeed, some will. Keep an eye open for the for-profit, non-FDA-approved ones and steer people away from those.
  2. We are seeing a flow of clinical trial data too pointing to encouraging outcomes, but also to challenges to overcome (witness the preclinical study on IPSC for heart attacks that found efficacy but also arrhythmias). With that kind of awareness such hurdles can be overcome in many cases as the work progresses.
  3. The FDA held public meetings on stem cells. We can grouch about certain things about these meetings and we can ding the FDA for various issues, but it never before has engaged with the community like this on stem cells so it’s a good thing.
  4. Stem cells firing on all cylinders: adult and pluripotent. Adult stem cell trials are building, but so now are pluripotent ones. The best way to help the most people in the long run is with all the tools (types of cells) we can utilize. The notion of “adult versus embryonic”, for instance, as some sort of cosmic battle seems out of date. We need both and also IPSC as well as other types as yet to come.
  5. The stem cell clinic problem out in the open. Never before has there been this much information and awareness out there on the problem of stem cell clinics taking advantage of vulnerable people. For instance, see my recent article with Leigh Turner and the one from John Rasko’s group. I believe awareness will translate into action for the positive.
  6. Putting the fun back in funding? NIH funding trends are looking at least slightly better overall which will help with stem cell research. CIRM is continuing its life extension and will fund many more projects in years to come. Other states are funding stem cell research too. It’s still a bad time for funding but the trend lines are at least moving the right way.
  7. Much more educational outreach on stem cells. When I started blogging about stem cells in early 2010 it was very quiet out there on the Internet in terms of those of us trying to educate a wider community in a positive manner. That’s really changed now with quite a few blogs that at least touch on stem cells and a number entirely dedicated to stem cells and regenerative medicine. This is a positive change and it means the public has more resources than ever to learn about stem cells.
  8. IPSC clinically-relevant work is looking up. It was a decade ago that IPSC cells were “born” and there were great expectations. Now 10 years later there are tangible signs that these cells will have lasting, huge impact including both from disease modeling and more recently via potential future clinical use.
  9. Stem cells meet CRISPR and…boom! Okay so everyone is nuts about CRISPR no matter what kind of cells they study including me, but CRISPR-Cas9 gene editing combined with stem cells in particular equals great potential both for new insights such as into human development and also potentially clinically through designer stem cells.
  10. Stem cell biotechs & stocks hanging in there. It has always been tough going for stem cell biotechs and that is likely to continue quite a while longer, but many are hanging in there and could surprise you down the road. Others have been acquired by pharma companies or inked collaborative deals in the last year or so. In the long run some of these companies are going to change medicine.

Muddier stem cell waters: Stemedica teams up with UCSD doc?

stemedicaAn increasing trend in the stem cell arena is the teaming up of clinical partners with very different backgrounds and priorities. For instance, academic institutions are more often working together with for-profit stem cell clinics.

Another branch of this larger trend is the observation that some publicly traded stem cell biotechs such as Bioheart are increasingly turning to non-traditional means of raising cash such as through dubious stem cell training for doctors or other unexpected ventures.

It seems that in the past things were clearer in terms of who is compliant and who isn’t, who is following the spirit of FDA regs and who isn’t, and so forth.

The waters of the stem cell world are getting far muddier today as I predicted in my top 20 predictions for stem cells in 2015.

It’s a somewhat radioactive topic.

Why?

On the one hand such team efforts between academic and industry could be beneficial by speeding translation to patients, which is what the field needs. Cheers for that.

However, on the other hand for-profit stem cell clinics and academics do not always see eye to eye on how to do things, how to report findings, bioethics, patient consent, stem cell tourism, the proper way to handle public relations, and such.

Increasingly the commercialization of stem cells is making for strange bedfellows.

A good recent example is the work just announced that Stemedica indicates links it with UC San Diego (UC) for a stem cell trial for Alzheimer’s Disease:

“The study is sponsored by Stemedica International, S.A. and will start at the University of California, San Diego (UCSD) under Principle Investigator Douglas Galasko, M.D. and expand to other sites.”

You may recall Stemedica from the media frenzy over the last half a year on their role in the treatment of hockey legend Gordie Howe for stroke. In fact, Howe reportedly just got a second treatment from Stemedica and its partner Novastem in Mexico.

I found some aspects of the whole Howe-Stemedica story to be of great concern. For example, there is some question over whether the free treatment of Howe has led to stem cell tourism via more patients traveling to Mexico for non-FDA approved interventions. Football great Bart Starr may also have recently gotten such a treatment via Stemedica as well.

Of this new Alzheimer’s trial, Stemedica says in a PR:

“This study was approved based on the excellent safety profile of Stemedica’s cGMP-manufactured, hypoxically-grown stem cells and on solid pre-clinical data obtained by Stemedica International in cooperation with the École Polytechnique Fédérale de Lausanne of Switzerland and with a grant from the Swiss government,” said Lev Verkh, Ph.D. Stemedica’s Chief Regulatory & Clinical Development Officer. He continued “We are very proud of Stemedica’s clinical program under U.S. INDs for several indications including ischemic stroke, acute myocardial infarction, chronic heart failure, cutaneous photoaging and Alzheimer’s disease. At the study’s conclusion we will understand if our approach is efficacious versus placebo in subjects with Alzheimer’s-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.”

Now in principle some definite good could come from Stemedica working with academics and notably they have an FDA-approved IND for this, which is great. At the same time there may well be different priorities at work. I guess we’ll have to wait and see how it goes.

Other stem cell clinics raise more concerns and claim university affiliations too. For example, earlier this year we saw an odd stem cell clinic with their NIH-like name (National Institutes of Regenerative Medicine; NIRM) turn out to be affiliated with Cell Surgical Network, the largest chain of stem cell clinics in the US, which sells non-FDA approved “therapies”. NIRM had claimed a UCSD affiliation as well, but I no longer see that apparent on their website today.

Notably, Stemedica is different in some key ways from the dubious stem cell clinics we often talk about. They have a growing number of FDA-approved INDs and by all accounts I’ve heard through the grapevine that the stem cells that Stemedica produces are cGMP quality. Still their actions have raised concerns on some levels and the promotion of stem cell tourism to Mexico is a worry.

Overall, as the stem cell waters continue to muddy and with essentially zero apparent regulatory action by the FDA’s CBER specifically on stem cell clinics more broadly in the last couple years, I predict it will be increasingly difficult to know what is going on with any particular stem cell offering. Instead of getting clearer, things are getting grayer.