Covid Research Backed by California's Stem Cell Agency: 15 Awards, Including Help with Three Clinical Trials

The California stem cell agency is down to its last $272,357 in its special, $5 million effort to help finance research involving Covid-19.

The research round began in May and has approved 15, fast-track research projects, including participation in three clinical trials. The latest awards were approved last Friday by agency directors. 

• Evan Snyder of Sanford Burnham Prebys Medical Discovery Institute received $250,000  to create lung organoids to test two drug candidates for treatment of the virus.
• John Zaia of the City of Hope received an additional $250,000 for his previously approved study dealing the use of convalescent plasma treatments. 
• Steven Dowdy at UC San Diego was awarded $150,000 to study a more effective way of delivering a genetic medicine, called siRNA, into the lungs of infected patients.

Summaries of the CIRM application review on the grants can be found here, including the six rejected.  

Approval of the latest awards came as a New Jersey firm that two weeks ago received a $750,000 award still has not disclosed the location of its clinical trial site in California. By law, the stem cell agency can only finance work within California.

The awardee is Celularity, Inc., a business whose proposed therapy is backed by Rudi Giuliani, the president's personal lawyer, who has also touted other possible Covid therapies, including one that has been rejected by the Food and Drug Administration.

In creating the Covid round, CIRM said award winners must be "ready to start work within 30 days of approval and propose achieving a clear deliverable within six months." It has been 16 days since the Celularity award was approved. 

The California Stem Cell Report has asked the firm repeatedly for the location of the California site but it has not responded. The agency itself also has not disclosed the location and defers to the company.

Sheehy Steps Back from Stem Cell Agency Positions; Cites His Opposition to Prop. 14

A longtime member of the governing board of the $3 billion California stem cell agency has stepped away from two leadership roles in the wake of his vote against the ballot measure that would refinance the research enterprise, which is running out of money. 

Jeff Sheehy, an HIV/AIDs patient advocate on the board since 2004, made the moves after becoming the only member of the 29-member board to vote against endorsing Proposition 14, which would provide $5.5 billion for the California Institute of Regenerative Medicine (CIRM), as the agency is formally known. 

The proposal would also make significant changes in the operations of the agency, enlarge its scope, lock up money for certain purposes and expand the size of its board from 29 to 35.

Sheehy voted against the endorsement on June 26 and released a statement to the California Stem Cell Report which cited a wide range of reasons for his negative vote. 

The actual vote on Proposition 14 was 21-1. Some members of the board were not present. Two vacancies also exist on the board. 

Sheehy was chairman of the board's science subcommittee. He was also a member of CIRM's grant working group and for years directed the evaluation by the full board of the billions of dollars in grant applications. 

Responding to a question last week, Sheehy said,

 "I instigated the change. I believe that it doesn't make sense for me to have any leadership roles given that I do not support Proposition 14.  I can imagine a scenario where the reality of my opposition becomes stark, and I don't want to drag the functionality of the board or the agency into any potential, campaign back-and-forth."

The changes in Sheehy's role became apparent last Friday when another board member led the evaluation of the Covid-19 applications. It came as a surprise to at least one board member, Vice Chairman Art Torres, who inquired at the beginning of the Friday meeting about the change. 

"What happened to Mr. Sheehy? He's not running these things anymore?" Torres asked.

Chairman Jonathan Thomas replied briefly, "Mr. Sheehy is is not going to be running the application review."

Torres replied, "Sorry to hear that."

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​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Buy it on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Saving CIRM: $5.5 Billion Ballot Campaign, Rhetoric and Winning

The campaign to save California's financially strapped stem cell research agency said this week that voter approval of a $5.5 billion rescue measure "has never been more important to the future of California’s health care, for the patients and their families, than it is now."

The pitch came in an opinion piece carried on the Capitol Weekly online news service. The article appears to be the first "op-ed" piece that the campaign has placed since qualifying the ballot initiative, Proposition 14. 

The article carried the byline of Robert Klein, chairman of the campaign effort, Californians for Stem Cell Research. Klein is the Palo Alto real estate developer who led the 2004 ballot campaign and directed the writing of the original initiative as well as the current one. He also was the first chairman of the agency, known officially as the California Institute for Regenerative Medicine (CIRM). 

Klein's article echoed rhetoric from the campaign web site, in some cases using identical phrasing, which is to be expected.  He wrote,

"CIRM funding has advanced research and therapy development for more than 75 different diseases and conditions, more than 90 clinical trials, more than 1,000 medical projects at 70 institutions across California and nearly 3,000 published medical discoveries. This investment has already saved and improved lives, including a high school student who was paralyzed in a diving accident and was able to regain function in his upper body and go on to college, a mother who went blind from a genetic disease has had some of her eyesight restored, two FDA-approved cancer treatments are already saving lives, and many more."

Klein's campaign piece pushed the envelope in some cases. One example is the mention of "more than 90 clinical trials." The agency itself only claims 64. The key to Klein's figure of 90 is the phrasing "CIRM funding has advanced ... more than 90 clinical trials." That is a different criteria than used by the agency. Klein is basing his figure on any kind of research connected in any way to any kind of trial. 

Klein's number of 90 has also climbed from 80 just 16 days ago.  

Additionally, Klein's claims in his article for the agency's economic benefits are based on studies that the agency itself has paid for as opposed to independent, third party analyses. The most recent example came last fall; the study cost CIRM $206,000. 

The 2004 campaign that established the agency was widely criticized for its hype. Most ballot campaigns can be criticized on the same grounds. However, none have dealt with science in the way that Proposition 14 does. But Klein's job is to win approval of the proposal. Without a victory in the fall, CIRM will begin to close its doors. 

California voters can expect to see more rhetoric like Klein's over the next three months or so, intensifying significantly in October. The same sort of rhetoric is  already coming from the opposition and can be more extreme. As the ChurchMilitant web site said on June 29, 

"California state officials have confirmed a ballot initiative that, if approved, would give a state biomedical agency $5.5 billion to kill human embryos in order to extract their stem cells."

All this -- Klein's envelope-pushing and opponents' emotional, religious screeds -- is part of the way ballot campaigns work in California. Cautious, deliberative discussions cannot be expected to carry the day for the partisans on both sides. It is war with a deadline. 

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​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Buy it on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Quote of The Day: Noah's Ark and the California Stem Cell Agency

'''CIRM operates at the nexus of the Political (with a capital P), scientific, institutional, and business forces of an aggressive state that views economic development as a priority.' Its organization, (Hamilton Moses) adds, doesn't help. ' 'Noah's Ark' boards, where each member is appointed to represent a constituency, rarely work.'"
 --  Hamilton Moses is a biomedical consultant in Virginia who focuses on non-profit governance, quoted in Nature Reports Stem Cells, from article Sept. 13, 2007, by Monya Baker

Bert Lubin: A Memory from a Sickle Cell Moment in 2008

Bert Lubin died last week. He was a member of the board of the California stem cell agency for a number of years, but what I remember him for was an appearance he made before the agency's governing board in 2008. 

Back then he was not serving as a member of the board. Instead he was a supplicant. And he was the first person to appear before the board seeking to reverse a negative decision by CIRM's reviewers.  

Lubin lost but not without raising a not-so-discreet ruckus. 

One board member, Gerald Levey, then dean of the UCLA School of Medicine, was more than irritated by Lubin's appeal of the reviewers' decision. I wrote at the time, 

"Levey said, "I don't think we can run a board this way. If we do, it would be chaos." 

"Levey was responding to a request by Lubin for a 10 minute presentation...of Childrens' case. Levey warned that allowing the presentation would lead to 50 other rejected applicants coming to the board.

"Director Joan Samuelson said that even 100 persons would be okay with her. She provoked laughter when she declared that the number would show more interest than at any other board meeting," the California Stem Cell Report wrote.

Ironically, the application involved sickle cell disease, a program that Lubin pioneered at Children's Hospital Oakland. In 2008, sickle cell was receiving little or no attention from CIRM. Today the agency is more than proud of its sickle cell arrangement with the National Institutes of Health.

Earlier this week, Kevin McCormack, senior director of communications for CIRM, wrote an item on Lubin for the agency's blog, The Stem Cellar. McCormack quoted Lubin as saying, 

"When I became the director of the research program we had $500,000 in NIH grants and when I left we had $60 million. We just grew. Why did we grow? Because we cared about the faculty and the community. We had a lovely facility, which was actually the home of the Black Panther party. It was the Black Panthers who started screening for sickle cell on street corners here in Oakland, and they were the start of the national sickle cell act so there’s a history here and I like that history. 

"Then I got a sense of the opportunities that stem cell therapies would have for a variety of things, certainly including sickle cell disease, and I thought if there’s a chance to be on the CIRM Board, as an advocate for that sickle cell community, I think I’d be a good spokesperson. So, I applied. I just thought this was an exciting opportunity."I thought it was a natural fit for me to add some value, I only want to be on something where I think I add value.” 

"Bert added value to everything he did."