3 CIRM challenges: search for new prez, funding, & clinical POW!

The idea of CIRM as a dedicated state stem cell agency was one of the things that got me excited about starting my time as a professor doing research on stem cells in California way back in 2005-2006 on the job hunt. Fast forwarding to today now 11 years later, CIRM is still on the cutting edge, but some major things have changed for California’s stem cell agency and as it looks to its future, the questions and challenges are different too.CIRM 2.0

By analogy, the original CIRM was at first like a stem cell itself navigating its differentiation branches as it went. The new CIRM of 2017, what some call CIRM 2.0, is in contrast more like a developing tissue. It has matured and has a history to build upon as it continues. Today CIRM and its staff aren’t newbies. They were newbies by necessity when I came to California in 2006 because they were literally inventing themselves with no past example to use as a model. Now they are stem cell veterans and CIRM is trying to sort out its fresh path ahead relative to its current path rather than strike a path from scratch.

Three key areas need tackling to navigate the new path for maximum positive impact.

Funding. Does CIRM 2.0 and its backers go for a “Prop 71 2.0” to get another round of California state funding? If so, how much and how to approach the voters? If not (or if “yes”, but the effort isn’t successful), where does CIRM get its funding to continue? Of course, in theory a third option is that CIRM simply ends when its current funding runs out, but to me that’s not a real option. CIRM cannot end because it has so much more to do and it is in some ways just getting to the most exciting part: the bedside part of the bench-to-bedside path. Update: over at California Stem Cell Report, David Jensen has the scoop on an industry-centric stem cell bond proposal idea.

New Prez. CIRM 2.0 President and CEO Randy Mills announced the surprising news recently that he’s moving on from CIRM after a relatively short, but impactful tenure. Who will be the new CIRM President? It’s anybody’s guess at this point, but I’d say that CIRM needs to achieve two things at once here: move very quickly to get a new leader and make that leader be a fantastic choice for CIRM. What exactly do I mean by the latter? The new CIRM President ideally should have impeccable stem cell credentials and also big picture clinical vision as well as strong leadership skills. I asked CIRM where things stand on the President search today and CIRM Sr. Director Public Communications & Patient Advocate Outreach, Kevin McCormack, provided this quote:

“the Presidential Search subcommittee is going to be meeting on July 17th to evaluate the options regarding appointing a permanent President and CEO to replace Randy. They’ll then make their recommendations to the full Board.”

I’m planning a future post to throw some names out on the table for discussion of people who might be considered for the position by CIRM.

Clinical POW! CIRM’s mission is focused on having transformative clinical impact so the agency needs some snap, crackle, and POW! on that front moving forward. It already has provided key support for a number of ongoing clinical trials and the goal moving forward is final approved products that are proven safe and effective. I would call that some stem cell POW! Not everything is going to be a success, but I predict that some will.

I believe that CIRM has the potential to achieve all this. That doesn’t mean it’ll be easy, but what great things have ever been easy?

LA Times Reports Stemgenex Doc Gets 3-Year Probation from State Medical Board

The world of stem cell clinics is on edge right now with a number of negative patient outcomes reported and lawsuits in play such as San Diego stem cell clinic Stemgenex being a defendant in a proposed class action lawsuit focusing in part on alleged problematic marketing claims on their website (see archived posts on the lawsuit).

Pulitzer Prize-winning LA Times columnist Michael Hiltzik has a new piece on both the broader stem cell clinic jungle out there and on specific issues with Stemgenex. It’s a must read for anyone who cares about stem cells.

Stemgenex Doctors

Stemgenex  team of physicians as a few months ago

Hiltzik goes through various concerns about the practices of Stemgenex and then breaks the story that one of the key Stemgenex doctors, Dr. Scott Sessions, was placed on probation by the California State Medical Board in February. The probation was not related to Stemgenex:

“There are other red flags. One of the medical group’s physicians, plastic surgeon Scott Sessions, was placed on three years’ probation by the California Medical Board in February. He was accused of negligence related to cosmetic surgery and other procedures he performed on two patients at an unrelated facility in 2011 and 2013.

Schubert told me Wednesday that “Dr. Sessions has informed us that he is in compliance with all requirements of the probationary terms of the medical board.” But the very next day, his name, photograph and bio had disappeared from the StemGenex website. Sessions didn’t respond to a request for comment.”

Sessions photo was up on the Stemgenex website (see image above) and then suddenly it wasn’t. Hiltzik also mentions that Stemgenex has had other questionable information on its website in the past.

With California having the most stem cell clinics selling non-FDA approved interventions of any state I hope the state medical board here will wake up to the fact that it needs to give this arena more attention.

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.