Stem Cell Perseverance in California: CIRM Tells Its Jam-Packed Story

A page from CIRM's annual report, which says that the girl is alive today
as a result of a clinical trial at UCLA that CIRM helped to finance.

The California stem cell agency, which is facing financial extinction, this week unveiled its latest annual report, which is a paean to its work and indirectly a pitch to California voters to refinance it with $5.5 billion. 

In an item yesterday on the agency's blog, The Stem Cellar, Kevin McCormack, wrote, 

"This latest CIRM Annual Report covers 2019 through June 30, 2020. Why? Well, as you probably know we are running out of money and could be funding our last new awards by the end of this year. So, we wanted to produce as complete a picture of our achievements as we could – keeping in mind that we might not be around to produce a report next year."

State law requires the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, to produce an annual report, much as publicly traded companies do. State law also forbids the use of taxpayer funds in ballot campaigns. But it does not forbid state agencies from engaging in their normal public information work. 

Dubbed "Perseverance: From Theory to Therapy," the annual report cost $34,000, according to the agency. The document makes a compelling case for adding $5.5 billion to the $3 billion voters provided in 2004 when they created CIRM. 

The multibillion dollar figures, however, do not include the projected interest costs to taxpayers, which bring the total estimated expense to something in the neighborhood of $13 billion. 

The $13 billion is also not mentioned in the annual report from CIRM, which is in keeping with the usual annual report traditions involving both public and private enterprises. They generally do not dwell on information that could be construed as less than upbeat, if at all possible. 

As expected, the report speaks highly of the agency's work, citing the 64 clinical trials in which it is involved. At the same time, a casual reader is likely left with the impression that CIRM financed the total cost of all of those trials, which is not the case. 

In another example of pushing the envelope, the document celebrates a study last fall that said that CIRM had an economic impact of more than $12 billion. CIRM characterized the report as "independent." CIRM actually paid USC, which has received $114 million from CIRM for stem cell research, another $206,000 to prepare the economic report. 

The annual report stated that the agency's efforts had a "significant impact" on the state's economy, which was estimated at $3.2 trillion annually in 2019. Twelve billion is 0.4 percent of that overall figure, something less than significant.  

CIRM's $5 million Covid-19 round is mentioned prominently at the front of the annual report in a move that CIRM hopes will resonate with voters when they are marking their ballots for or against Proposition 14, the stem cell measure. The $5 million is, again, a tiny amount when compared to the billions being spent nationally for Covid research. 

All that is not to say that CIRM has not performed significant work. It definitely has left a major mark on the stem cell field nationally and even globally. Some of the 2,000 people participating in the clinical trials have benefited. The agency has fostered collaboration on stem cell research between institutions that probably would not have occurred without a financial stimulus from CIRM. And it has created a new, speedy, grant-review model that puts research money in the hands of researchers more quickly.  

More can be said, but you can find it all in what perhaps will be the last annual report from an enterprise that is unique in California history and unique in size and scope among all the 50 states.

Read the California Stem Cell Report regularly for the latest and most in-depth coverage of the effort to save the California stem cell agency from financial extinction. 

Bakersfield Californian Says No to Proposition 14, the Multibillion-Dollar Stem Cell Measure

The Bakersfield Californian is likely the first paper in the state to take a stand on the $5.5 billion California stem cell measure, advising its readers to reject the "mega-bond" as financially unwise. 

In an editorial published online yesterday, the newspaper said, 

"As California continues to struggle under the catastrophic burden of the coronavirus pandemic, increasing state budget deficits loom, public service cuts are likely and economic recovery is likely to take more than a decade.

"In 2009, President Barack Obama lifted most of the restrictions on federal funding for embryonic stem cell research and demand for the cells has been greatly reduced as other research and technologies have advanced.

"Adding $5.5 billion to the state debt for just stem cell research would be unwise in these economically dire times. Vote NO on Proposition 14."

The newspaper also said that the agency, officially known as the California Institute for Regenerative Medicine (CIRM),  "created an impressive infrastructure of research institutes." The Californian continued,

"Stem cell research greatly advanced in California, but the promised spectacular breakthroughs have lagged – a result of the tedious and time-consuming nature of research.... 

"Voters and earlier proposition advocates should be proud of the progress the initial $3 billion stem cell investment has accomplished. But times have changed and passage of another mega-bond now would be unwise."

How important are newspaper endorsements nowadays? They are one concrete standard that campaign managers can be measured against, so they may take on outsized importance. But newspapers are a dying breed, reaching fewer and fewer readers. Even in their heyday, decades ago, only about 25 percent or so of readers turned to the editorial pages on a regular basis. 

However, a wave of negative editorials could take on a life of its own, leading to mentions in the coverage of Proposition 14 as an indicator that the measure is in trouble.  That said, don't expect heavy coverage of the proposal. 

Both print and online news media are short-staffed. Most of their efforts will focus on higher-profile issues, including presidential matters, local ballot races and other propositions, such as rent control and property taxes involving the state's sacrosanct Proposition 13. 

And for the record, Proposition 14 will cost taxpayers an estimated $7.8 billion because of the interest on the $5.5 billion that the state will have to borrow.

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Read the California Stem Cell Report regularly for the latest and most in-depth coverage of the effort to save the stem cell agency from financial extinction. 

UC Irvine Named for Covid-19 Trial Backed by California Stem Cell Agency and Giuliani

A New Jersey firm backed by $750,000 from the California stem cell agency today announced that the California location of its Covid-19 trial will be at UC Irvine.

The firm is Celularity, Inc., and its proposed therapy is supported by Rudi Giuliani, President Trump's personal lawyer.  Celularity expects to complete its work by Nov. 30.

CIRM said the research involves "a phase I/II study of human placental hematopoietic stem cell derived natural killer cells for the treatment of adults with COVID-19."

The award was made June 26 by the agency's governing board, which expected its Covid grantees to be ready to start work within 30 days under its fast-track Covid round. Celularity had not responded to questions about the trial location prior to its news release today. The stem cell agency cannot fund research outside of California. 

The company's news release indicated there would be more locations in California, but did not disclose any. 

The UC Irvine work will be overseen by Leonid Groysman, a neurologist. Here is a link to a summary of the review of Celularity's application (CLIN2COVID19-11857 #2). 

California's $5.5 Billion Stem Cell Campaign and Covid-19: How Science and Politics Marry

Editor's note: The following item written by the producer of the California Stem Cell Report appeared yesterday on the Capitol Weekly online news service. 

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The California stem cell agency has just finished pumping $5.3 million into the fight to save the lives of COVID-19 victims. And — in a ballot-box bonus — its efforts are already surfacing in the ballot campaign to rescue the agency from its own demise.

The agency is running out of money. It will begin closing its doors this fall without major financial support that it hopes will come from Proposition 14, a $5.5 billion bond measure on the November ballot.

The $5.3 million in the fast-track, Covid program is tiny by comparison. But the awards are likely to play a heftier role than might be anticipated based on their size. Stories about the Covid awards have appeared on the campaign website in a move to tap into the deep public concern about the coronavirus.

The Covid research piggybacks on the federal “warp speed” drive to develop Covid treatments and is aimed at demonstrating that the agency is part of what CIRM officials describe as a worldwide, “all-hands-on-deck” effort.

Three clinical trials have been funded, which involve actual patients as opposed to laboratory research. If the trials are successful, patients who have benefited are likely to surface in campaign video advertising aimed at refinancing the agency, formally known as the California Institute for Regenerative Medicine (CIRM).

CIRM sorely needs research results that will resonate with voters. The 2004 ballot campaign that created the $3 billion program raised expectations that stem cell therapies were right around the corner. But the agency has yet to produce a stem cell treatment that is widely available to the public.

The agency launched its Covid round on March 27 when CIRM board chairman Jonathan Thomas declared, “The coronavirus is creating an unprecedented threat to all of us, and, as one of the leading players in regenerative medicine, we are committed to doing all we can to develop the tools and promote the research that will help us respond to that threat.”

Indeed, failure by CIRM to respond to the COVID-19 threat — it could be argued — would be a breach of CIRM’s public responsibilities.CIRM’s Covid research financing is a case where an urgent medical need marries nicely with ballot-box politics. The agency is forbidden by law to campaign for the ballot measure. But its charter also allows it to pursue a wide range of research possibilities.

Late last month, CIRM directors capped off the round by approving two awards and adding nearly $300,000 to the original authorization of $5 million. All of the awards have been made under an emergency process that requires awardees to be ready to begin research within 30 days and achieve “a clear deliverable within six months.”

The final awards went for basic level research. Earlier, CIRM approved funds to assist in the three clinical trials, which are the final stage before a treatment can be approved for widespread public use. The trial awards range from $1 million to $701,000 each, a bargain price for joining a trial. Most of CIRM’s previous clinical trial awards run into many millions.

CIRM now counts a total of 64 clinical trials that it is helping to finance. Two of the Covid trials are taking place at the University of California, San Francisco-UC Davis and the City of Hope in the Los Angeles area. The third involves a New Jersey firm called Celularity, Inc., which has failed to respond to multiple questions about the California location of its trial. The agency is limited to funding activities within the state. CIRM directors approved the Celularity award on June 26, more than 30 days ago.

The Celularity award has another interesting angle. It involves a treatment supported by President Trump’s personal attorney, Rudi Giuliani. 

You can find more information about all the awards in a series of items on CIRM’s blog, The Stem Cellar, using the search term “covid.”   Five CIRM/Covid stories, including CIRM blog items about the Covid round, have been placed on the campaign website by the campaign staff. 

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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

Jonathan Shestack, in 2013 and then a patient advocate member of the governing board of the California stem cell agency, speaking about patient advocates appearing before the board:

"We have a responsibility to look those people in the face.... So I would like to be very careful as we retool that process to make it neater and less chaotic and not upsetting to the press or to people in Sacramento, but to understand that is part of our responsibility, to look at those people and listen to them and take some of what they have to say into consideration."

From a meeting of the CIRM board Jan. 23, 2013