SCOTS, Selling Stem Cells, & More Patient Claims of Blindness

Have more patients been blinded by stem cell clinics?

The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning of information beginning to flow on negative outcomes for patients who are customers of stem cell clinics selling non-FDA approved offerings. The NEJM authors linked the loss of vision to interventions received by patients from the publicly-traded company US Stem Cell, Inc., but different patients also in Florida have been alleging that they were blinded by a different entity, the “SCOTS trial”.

Steven Levy Jeffrey Weiss

Drs. Steven Levy & Jeffrey Weiss, leaders of the SCOTS trial.

I’ve blogged about SCOTS several times before including the patient allegations of being blinded and various other concerns. Now there’s a new BBC investigation on these allegations reported in a striking radio broadcast.

Two physicians are central to the SCOTS trial, Drs. Steven Levy and Jeffrey Weiss. A number of patients have alleged negative experiences including patient George Gibson, who is one focus of the BBC report. But by contrast another patient named Doug Oliver has said that he had very good results from SCOTS. How do we in the broader stem cell community try to understand the SCOTS situation? It’s difficult right now, but can we learn anything from the BBC investigation? Continue reading

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.

Report on day 2 of FDA stem cell meeting: patients, researchers, & more

The FDA’s stem cell meeting wrapped up today on day two with a diverse group of individual speakers. A series of patient testimonials today in favor of clinics was one thing that stood out. You can read my take of day one and the account of Jeanne Loring who was at the meeting. I’ve noted that on average about 350 people were watching the webcast of the meeting both days.

fda-stem-cell-meeting-day-2

Screen shot from FDA stem cell meeting webcast

The patients gave powerful, often emotional testimonials today on their experiences at various stem cell clinics including Celltex and most prominently Stemgenex. I think there were 7 of its patients who spoke. I have no doubt of the patients’ sincerity in their belief that they’ve been helped.

Various stem cell clinic doctors also testified.

As with yesterday, a common statement was that there are “no side effects” of stem cell treatments, which is concerning as all medical therapies have some risk of side effects.

Continue reading

Stem cell news bites: chimeras, Australian clinics, organoids & more

brain organoids

screenshot from Reuters video

Some recent developments in the stem cell world are worth a look.

I’ve posted the headlines verbatim and the links to some of these stem cell news bites below.

NIH Plans To Lift Ban On Research Funds For Part-Human, Part-Animal Embryos. NIH may allow funding of human-animal chimeras in certain cases.

Stem cell ‘tourists’ flock to Australia. How many stem cell clinics are there in Australia?

ICYMI: Leigh Turner and my Cell Stem Cell paper on US Clinics. The stem cell clinic situation in the U.S.

Brunswick woman taking gamble that stem cells will restore vision. A risky and costly experimental intervention.

Singapore scientists grow human ‘midbrain’ from stem cells. What can’t be grown with organoids?

Stem Cells and the Frozen Zoo. How cool and important.

Listen to Leigh Turner’s interview on Science Friday on our stem cell clinic paper

Leigh TurnerYou can listen to my co-author Leigh Turner’s interview on Science Friday here about our Cell Stem Cell paper on the stem cell clinic industry in the U.S. Start listening around the 8:30 mark.

It’s great that this paper has so strongly raised awareness about the booming stem cell clinic industry in America as well as the urgent need for much more open and active discussion of the serious issues that this reality raises on a number of levels.

You can follow Leigh on Twitter here.

Also, you can read about Leigh’s excellent presentation about stem cell clinics that he gave at ISSCR Vancouver here.