Does stem cell clinic IRB approval mean much? Insights from blinding cases

Could the blinding of three women at a stem cell clinic have been prevented by better oversight or was the clinic acting outside of the scope of oversight by its institutional review board (IRB)?

More broadly, when is an IRB conducting proper oversight and how do we know? When on the other hand is it not being careful enough or even outright enabling risky behavior by those selling non-FDA-approved, experimental stem cell “treatments”?

It can be hard to really be sure. What makes this area particularly muddled is that most of what IRBs do is confidential. We in the stem cell community are as a result left with a bunch of questions in general and about specific cases such as the blinding of these women.

When things go wrong and patients have bad outcomes how much is the responsibility of an IRB versus the stem cell clinics doing the actual experiments? Stem cell clinics often point to their IRB-approved status as some kind of merit badge, but how much does that approval mean? My goal in today’s post is to tackle that last question.

stem cells eyes

Kuriyan, et al. 2017 NEJM Figure 2A showing patient with severely damaged eyes leading to loss of sight

Over at BuzzFeed reporter Peter Aldhous has been following the story of the three women who were blinded by experimental offerings of US Stem Cell, Inc. In Aldhous’ new article he focuses more on US Stem Cell’s IRB. This IRB was run by an organization called the International Cellular Medicine Society (ICMS), which in theory was responsible for overseeing work of US Stem Cell.

There are a host of questions about what happened leading to the women losing their vision and what if any role the ICMS IRB had in overseeing the experiments on these patients. Did US Stem Cell wander outside the scope of ICMS IRB oversight in this case? Could the ICMS IRB have done a better job? If the ICMS IRB did its job well here, I still wonder how they can help to prevent more bad outcomes like this from happening? Presumably the ICMS IRB is overseeing work by many other stem cell clinics as well. How much risk is there at those places? If a business doesn’t follow its IRB’s rules, what happens then? It’s hard to find answers to questions like these. Continue reading

What’s the deal with US Stem Cell Inc stock?

The stem cell clinic business US Stem Cell Inc., formerly known as Bioheart, has seen its stock take a rollercoaster ride recently include a big run up and now today a big drop so what’s the scoop?

US Stem Cell, which includes a few subsidiaries such as US Stem Cell Clinic, focuses on the use of adipose stem cells to treat a variety of health conditions in people, as well as training and pet treatments.

US Stem Cell Inc Stock USRM

To my knowledge, the company does not have FDA approval such as an IND for the stem cell interventions that it sells. In addition, there is some debate over whether adipose stem cells/stromal vascular fraction is a biological drug. As a stem cell scientist and close follower of the field, I believe it is a drug. Note that I’m not aware of the FDA having taken any action on US Stem Cell or its competitors who use adipose stem cells. The company has also recently settled two patient lawsuits, which included allegations of harm to vision by a number of entities.

On the potential upside for investors, it seems there remains strong demand across the US and the world amongst patients for what stem cells clinics are offering even without FDA approval.

Why is the US Stem Cell Inc stock moving so much recently?

It looks like an investment research firm put out a report on the company and the report apparently details the company making deals outside the U.S. and in the Middle East so this may be part of what is driving the stock to move around.

There also seems to be something recent about a lawsuit settlement on social media, but seems pretty vague so hard to say if it is accurate or means something.

Any other thoughts?

Disclosure: I have no investment in stem cell/regenerative medicine stocks including US Stem Cell or its competitors.

Update on patients lawsuit against stem cell clinic, Stemgenex

StemGenexThe website Law360 has an interesting update on the proposed class action lawsuit against the San Diego stem cell clinic Stemgenex.  Note that it seems you can read the full Law360 article without a subscription if you open the site in Chrome as your web browser. See more background on Stemgenex and on this case here.

Not surprisingly, the plaintiffs and defense see this case in opposite ways as reflected in quotes in the Law360 article:

“Plaintiffs make non-specific and conclusory allegations with respect to all named defendants,” StemGenex said. “The second amended complaint is so devoid of any specific facts to support its contentions that it is impossible for defendants to reasonably prepare a defense.”

Brian Findley of Mulligan Banham & Findley, a lawyer for the plaintiffs, told Law360 Wednesday that the allegations are “quite specific” and cite false statistics, made-up online reviews and StemGenex employees. If customers told the company that the treatment hadn’t done anything, they were told it could take months to see an effect, or that they should buy another treatment, he said.”

A key issue in this case is the marketing of stem cell offerings from Stemgenex and the plaintiffs allege this marketing was problematic:

“The three StemGenex customers, Selena Moorer, Stephen Ginsberg and Alexandra Gardner, all say that they paid the company $14,900 for each stem cell treatments for lupus, diabetes and other ailments after being persuaded by the number of satisfied customers on the company’s website, but that the treatments had no effect.”

The Stemgenex website still lists an apparent 100% patient satisfaction marketing claim as of today, January 23, 2017 (see screenshot below).

stemgenex

Screenshot from Stemgenex website

According to the Law360 article, Stemgenex has made various arguments to support their motion for dismissal and they overall called the lawsuit a “fishing expedition.”

If you want to follow the case, here is some info:

“The case is Moorer v. StemGenex Medical Group Inc., et al., case number 3:16-cv-02816, in the U.S. District Court for the Southern District of California.”

It seems likely that more patient suits against stem cell clinics will emerge this year. Some, but not all of the other recent cases of this kind including against US Stem Cell, Inc. and its subsidiary US Stem Cell Clinic have been settled before any judgment was issued. I’m not sure of the status of a different proposed potential class action case against The Lung Institute. If you know of other such lawsuits please contact me or post a comment.

Stem cell checkup: how are my 2016 predictions doing half way?

Stem Cell PredictionsEach December I make stem cell predictions for the coming year and I did that for 2016 where I made 20 predictions. At around mid year I do a checkup on how my predictions are doing halfway and that is the purpose of this post.

Below are my predictions that I made in 2015 for stem cells in 2016 and my general sense in green of where they stand. Overall, I’m doing reasonably well, but I kind of wish I wasn’t because so many of these are not positive developments. However, in general I remain very optimistic for the field and expect major positive advances in coming years on a number of fronts using both adult and pluripotent stem cells.

The predictions and status so far.

  1. Another stem cell biotech acquisition by pharma (recall Ocata (now finally sold to Astellas) & CDI in 2015). Checkup: Not yet.
  2. Charging patients for clinical trial participation, particularly in Japan due to the new policy and here in the US related to predatory clinics remains a hot topic. Checkup: Correct.
  3. Stem cell clinics and doping in sports flares up more. Checkup: Clinics yes, doping not yet.
  4. Organoids continue to excite. Checkup: Correct. What a great technology.
  5. Bioheart and some other small stem cell companies struggle. Checkup: Correct so far. The PPSs of small stem cell biotechs have generally not been pushed up this year by investors, but rather the reverse. Note that Bioheart is now called US Stem Cell, Inc. We can all hope that there is a turnaround for small stem cell biotechs in the market in the 2nd half of the year.
  6. Stem cell stocks overall have a bad year. Checkup: Correct so far also sadly. Note, by way of disclosure I do not currently have any direct stem cell stock investments.
  7. Stem cell clinics ever more aggressively use celeb clients for PR and marketing Why? It is powerful, effective, and essentially free advertising. Checkup: Correct.
  8. More news on human-animal chimeras. Checkup: Correct. Another hot topic.
  9. FDA continues its slow-go approach to action on stem cell clinics/unapproved stem cell products. Checkup: Correct.
  10. Pressure from industry and some academics on FDA to not regulate adipose products as drugs and/or to not enforce some other draft guidances including at the upcoming public hearing on the draft guidances. Checkup: Correct. REGROW and other efforts have been unprecedented. Note that the FDA public meeting will now be held in September rather than in April.
  11. FDA receives increasing public criticism for “slowness” on approving new stem cell therapies including from beyond the stem cell clinic industry. Checkup: Correct in a big way. 
  12. One or more lawsuits against a stem cell clinic. Checkup: Correct and several more seem to be brewing. Note that it appears that the part of the suit involving US Stem Cells, Inc. has been settled, while a separate part of the case against other defendants continues.
  13. A new stem cell scandal pops up related to publication issues. Checkup: Correct. You just have to go visit Retraction Watch (e.g. the Spain mess) or PubPeer, and then also see the continuing Macchiarini saga.
  14. Some hiccups on mitochondrial transfer/3-person IVF in the UK or China. Checkup: Correct. Diseased mitochondrial carry-over and mito-nuclear cross-talk issues have popped up and deserve serious attention.
  15. The trend last year of increasingly blurred lines between legit research entities such as universities and dubious stem cell enterprises continues. This is worrisome. Checkup: Correct.
  16. Stem cell-derived human germ cells stay in the headlines. This has exciting potential for providing new windows into human development and tackling infertility, but also raises thorny issues such as human genetic modification. Checkup: Correct.
  17. ViaCyte has some big newsCheckup: Not yet. What a great company.
  18. High-profile developments on veterinary use of stem cells. Checkup: Correct. For instance see this piece in Scientific American. Cool stuff!
  19. Animal cloning, particularly in China, continues to proliferate. Checkup: Correct.
  20. More rumblings on possible human reproductive cloning attempts. Checkup: Not much concretely yet. See this piece on cloning focusing on 20th Anniversary of Dolly.

Stay tuned as near the end of 2016 I will do a final assessment of how I did on my stem cell predictions and then make stem cell predictions for 2017. What are your stem cell predictions?