Stem Cell Contingency Planning in California: Winding Down a $3 Billion Operation

The $3 billion California stem cell agency has put together a "wind down" budget for its coming fiscal year -- a spending plan that takes into account the possibility that voters will not refinance the effort with more billions this fall. 

The budget was approved by the agency's governing board finance committee last week. It proposes spending $12.3 million for the 12 months that begin July 1. Should voters reject a $5.5 billion refinancing of the agency in November, the plan anticipates a 42 percent staff reduction at the end of this year. 

The agency is now down to 33 employees, who have numbered more than 50 in past years. 

Maria Millan, CEO of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, said that details of the plan will be fleshed out as the year progresses.  It will also be discussed at a governing board meeting on June 26.

She said that CIRM has $854 million in awards under current management. They would be phased out over the next several years. Millan said that $47 million is available currently for research awards. Decisions on the use of the money will come before the board, also on June 26. 

If the ballot measure is approved, the agency's budget will require substantial modification and hiring to deal with the increased funding and new activities provided for in the ballot measure. 

During the public comment period, David Jensen, publisher of the California Stem Cell Report noted the  significance of CIRM both as an historic state enterprise and for its scientific impact on the stem cell field. He said, 

"Preserving the CIRM story digitally in a readable and accessible format should not be all that costly. And it would be a significant contribution to helping those who come after us learn about how this $3 billion effort came about and navigated with considerable success through the early days of what some may ultimately call the stem cell revolution. It would be a sad day if the complete record of the California Institute for Regenerative Medicine is not preserved for posterity." 

Several CIRM board members expressed enthusiasm for the suggestion. Millan said that archiving the data and information that CIRM has gathered is part of the wind down proposal under its public communication component. 

*This item has been brought to you by The California Stem Cell Report: The only independent source of information and news devoted solely to the stem cell agency for the last 15 years.*

California's $5.5 Billion Stem Cell Countdown: 50,236 More Signatures Needed

A $5.5 billion stem cell initiative this afternoon remained shy of qualifying for California's November ballot with only five business days remaining before the count must be complete.

The proposed ballot measure is aimed at saving the state stem cell agency, which is running out of cash. It will begin closing its doors in the fall without more funds. 

State officials today reported 635,298 verified signatures of registered voters, up from yesterday's 610,742. The campaign's goal is 685,534. The qualification rate is steady at about 78 percent. 

The measure needs only 50,236 more to hit 685,534. Six counties with a total of 115,400 raw signatures have not completed their verification. The largest is San Diego, with 99,899 unverified. The others are Butte, 6,502; Inyo, 610; Kings, 1,756; San Mateo, 6,491, and Trinity, 142. 

The state has set June 24 as the deadline for counties to complete their tally. The state's deadline for itself is June 25.

(It is too late for more persons to sign petitions for the campaign.)

Look for the next update on the count tomorrow evening or early Friday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Text: State Summary of 2020 Stem Cell Ballot Initiative

Here is the text of the summary of California's $5.5  billion stem cell ballot measure from the secretary of state's office.

"Authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine to educational, non-profit, and private entities for: 

"(1) stem cell and other medical research, therapy development, and therapy delivery;

"(2) medical training; and 

(3) construction of research facilities. 

"Dedicates $1.5 billion to fund research and therapy for Alzheimer’s, Parkinson’s, stroke, epilepsy, and other brain and central nervous system diseases and conditions. 

"Limits bond issuance to $540 million annually. Appropriates money from General Fund to repay bond debt, but postpones repayment for first five years. 

"Summary of estimate by Legislative Analyst and Director of Finance of fiscal impact on state and local governments:

"State costs of $7.8 billion to pay off principal ($5.5 billion) and interest ($2.3 billion) on the bonds. Associated average annual debt payments of about $310 million for 25 years. The costs could be higher or lower than these estimates depending on factors such as the interest rate and the period of time over which the bonds are repaid. The state General Fund would pay most of the costs, with a relatively small amount of interest repaid by bond proceeds."

(Boldface by secretary of state's office.)

California's $5.5 Billion Stem Cell Countdown: Only 74,792 Signatures Left to Go

The effort to qualify a $5.5 billion stem cell initiative for California's November ballot gained 24,606 signatures this afternoon with only six business days remaining before the count must be complete.

The proposed ballot initiative is aimed at saving the state stem cell agency, which is running out of cash. It will begin closing its doors in the fall without more funds. 

State officials today reported 610,742 verified signatures of registered voters, up from Monday's 586,136. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. 

The measure needs only 74,792 more to hit 685,534. Eight counties have not completed their verification, including San Diego, with 99,899 unverified. 

The state has set June 24 as the deadline for counties to complete their tally. The state's deadline for itself is June 25.

Look for the next update on the count tomorrow evening or early Thursday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

California's $5.5 Billion Stem Cell Countdown: San Diego County, With 99,899 Raw Signatures, Still Working on Verification

An effort to place a $5.5 billion stem cell initiative on the November ballot in California notched another 48,578 signatures this afternoon with only seven business days left until the count must be complete.

The proposed ballot initiative is aimed at saving the state stem cell agency from financial extinction. The 15-year-old program is running out of cash and will begin closing its doors in the fall without more funds. 

Last week, the California Stem Cell Report analyzed the trends in the tally, concluding that qualification is in the "virtual bag."

Today's tally from state officials showed 586,136 verified signatures of registered voters, up from Friday's 537,558. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot. 

The measure needs only 99,398 more to hit 685,534. Ten counties have not completed their verification, including San Diego, with 99,899 unverified. Fresno follows with 29,073 and Contra Costa with 23,167. The remaining counties have much smaller numbers of raw signatures.

The state has set June 24 as the deadline for counties to complete their tally. The state's deadline for itself is June 25.

Look for the next update on the count tomorrow evening or early Tuesday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Covid-19 and Stem Cell PR: Informing Voters, Loosening Their Pursestrings

The California stem cell agency often has trouble making it into mainstream media coverage, but last week it popped up in a piece involving its special Covid-19 round. 

Some of the "normal" grants from the agency run upwards of $20 million. But in this case, it involved only $701,049. The award carried extra news heft for the San Francisco Chronicle because it went to a local institution, UC San Francisco, and was connected to the hottest medical story in the world. 

Michael Matthay of UCSF was the recipient of the cash on May 15 from the California Institute for Regenerative Medicine (CIRM). Matthay has a phase two clinical trial 

Michael Matthay
UCSF photo

underway for acute respiratory distress syndrome, which can kill patients with severe cases of Covid-19. He is using intravenous doses of mesenchymal stem cells (MSC) to help damaged lungs repair themselves. Results will not be known for probably about a year. 

The award will largely be used to expand the clinical trial to UC Davis. 

In a letter to the CIRM board, Matthay said, 

"UC Davis serves a population that includes underserved patients, and therefore adding UC Davis as a clinical site will serve the CIRM mission well. Also, please note that our UCSF Alpha Stem Cell application was focused on underserved patients in the East Bay (Sickle Cell Disease) and in San Francisco (Zuckerberg San Francisco General Hospital)."

Running the Davis site will be Rachael Callcut, who led the site at San Francisco General until joining Davis in March, and Tim Albertson,  chair of internal medicine at UC Davis. 

Rachael Callcut
UC Davis Photo

In  Matthay's letter he defended his application (CLIN2COVID19-11823) against criticism by the anonymous reviewers who evaluated it for CIRM. The application was initially not approved by the reviewers, who gave it a score of 72 out of 100. The score was so low that it fell outside the range of normal funding. Among other things, the review summary said that reviewers disagreed about the rationale of the research and expressed concerns about whether enough Covid-19 patients could be enrolled. 

Matthay said in a letter to the CIRM board that 11 Covid patients were already enrolled. As for the rationale, he said, 

"There is substantial pre-clinical data that MSC therapy can decrease lung injury from bacterial and viral pneumonia and hasten lung repair. Our group and other investigators have reported several pathways by which MSCs can reduce inflammation in the lung." 

After receiving the letter and hearing from Matthay via telephone at the meeting, the board overrode the reviewers' action and approved the proposal. 

While Matthay's work received favorable notice in the Chronicle article (written by J.D. Morris), for CIRM it was a mixed bag. The first mention of the state funding said, 

"California has invested billions of dollars in public funds to advance stem cell therapies over the last 15 years or so and, while researchers have made some important progress, a 2018 Chronicle series found that the advancements did not live up to the original promise of the 2004 ballot measure that funded the scientific endeavor."

CIRM fared somewhat better in the next mention in Morris' story: 

"Matthay has no guarantee that the stem cells he’s studying will be useful in treating COVID-19. But it’s worth a shot, said Jonathan Thomas, the board chairman of the regenerative medicine institute. 

"'Given that we’re dealing with something the world’s never seen before, it behooves everybody who has potential ideas to be heard,' Thomas said. 'The notion of stem cell-related treatments ... is something that at least we have to give the opportunity to have a full consideration.'"

Why does the play in the story, its use of photos (three in all) and wording matter?  CIRM is all but unknown to California voters today.  As the proposed, stem cell ballot initiative gains more attention, ongoing media coverage will become increasingly important. It will shape the perceptions of voters who are going to be asked in November to provide $5.5 billion more for CIRM, which is running out of money. The agency has handed out nearly all of the $3 billion that voters provided it in 2004. 

The CIRM story has plenty of plenty of pluses and minuses. CIRM and its backers hope that voters will see more pluses than minuses in the media and vote to continue to finance the agency's search for stem cell treatments for everything from cancer to incontinence. 

$500,000 to Fight Covid-19 from California's Stem Cell Program

The California stem cell agency on Friday awarded a total of $500,000 to two UCLA scientists to help in the fight against Covid-19, including early stage research aimed at boosting the immune response of older persons. 

The grants are part of a $5 million, "emergency" Covid round that is aimed at fast-tracking promising research. 

Song Li (left) and Vaithilingaraja
Arumugaswami, UCLA photos

Vaithilingaraja Arumugaswami

received $350,000 for work dealing with Berzosertib, a therapy targeting viral replication and damage in lung stem cells. 

Arumugaswami said in a UCLA news release, 

"Clinical trials have shown that Berzosertib blocks the DNA repair pathway in cancer cells, but has no effects on normal, healthy cells. For this reason, we think this drug shows great promise for treating COVID-19 patients and could be rapidly and safely be deployed in the clinic."

A summary of reviewer comments on his application (TRAN1COVID19-11975) can be found here. 

Song Li received $150,000 to help develop an injectable biomaterial that can induce the formation of T memory stem cells, which are important in generating an immune response. 

Li said that if his work is successful, it could have applications well beyond Covid-19. A summary of reviewer comment on his application (DISC2COVID) can be found here. 

Directors of the agency rejected six applications in their action on Friday. Summaries of all application reviews can be found here. 

The stem cell agency, which is running out cash, is now supporting 11 Covid-19 projects, including two clinical trials. The fast-track Covid round is accepting applications every two weeks. More awards are expected when agency directors meet again on June 26. 

The agenda at that time will include other matters such as the budget for the coming 12 months, including a wind-down schedule should voters reject a $5.5 billion ballot measure to refinance the agency, which is running out of money. 

  

Click on this sentence to see the agency's press release on last week's awards. 

California's $5.5 Billion Stem Cell Countdown: Total Now up to Nearly 540,000

California county elections officials have been tallying
signatures on stem cell initiative petitions for one month.

Nearly 27,000 signatures were added today as the $5.5 billion effort to rescue the California stem cell agency moved slowly towards an all-but-assured position on the November ballot

The proposed ballot initiative is aimed at saving the agency from its financial demise. The 15-year-old program is running out of cash and will begin closing its doors in the fall without more funds. 

Earlier this week, the California Stem Cell Report analyzed the trends in the tally, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 537,558 verified signatures of registered voters, up from yesterday's 510,930. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Look for the next update on the count Monday evening or early Tuesday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

California's $5.5 Billion Stem Cell Countdown: Campaign Not Likely To Sue for Deadline Extension

Solano County contributed 7,670 signatures this afternoon to the snail-like progress of a $5.5 billion stem cell research proposal towards a virtually assured position on the November ballot.

The measure is aimed at saving the California stem cell agency from fiscal extinction. The 15-year-old program is running out of cash and will begin closing its doors in the fall without more funds. 

Earlier this week, The California Stem Cell Report analyzed the trends in the count, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 510,930 verified signatures of registered voters, up from yesterday's 503,260. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 14 counties out of 58 have not filed their verification numbers.

If the stem call initiative comes up short, it could join the effort to force the state to extend the deadline. Two groups have already sued seeking more time. One effort involves sports betting at Native American casinos. The other involves data privacy. The basic argument is that the Covid-19 crisis seriously and unexpectedly hampered the signature gathering which is constitutionally protected process. 

However, in response to a query, campaign spokeswoman  Sarah Melbostad today said,

"We have been pleased with the validity rates we’ve seen so far and are still confident that we are going to qualify for the November 2020 ballot. We have no plans to join these lawsuits or to file our own."

Look for the next update on the count tomorrow evening or early Saturday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

California's $5.5 Billion Stem Cell Countdown: Inching Towards November 3

San Francisco stepped up today to provide 10,900 signatures to help the California stem cell agency refinance itself through a $5.5 billion initiative that is headed for the November ballot. 

What's at stake is qualifying the proposal so that it will be presented to voters in the fall. Earlier this week, The California Stem Cell Report analyzed the trends in the count, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 503,260 verified signatures of registered voters, up from yesterday's 492,349 . The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 15 counties out of 58 have not filed their verification numbers. For stem cell history buffs, San Francisco, once known as Baghdad by The Bay, also was once known as the home of the stem cell agency for a number of years. The city won the headquarters in a bidding war after it promised $18 milion, including 10 years in free rent. The agency moved to Oakland when the free rent ran out because of the high cost of office space in San Francisco.

California Gov. Gavin Newsom was then mayor of San Francisco and played a major role in reeling in the stem cell agency. He has not spoken publicly about whether he supports the $5.5 billion initiative. 

Look for the next update on the count tomorrow evening or early Friday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

California's $5.5 Billion Stem Cell Countdown: The Official Tally Creeps Towards the Certainty of November

Watching the Signature Numbers

* The campaign is seeking 110 percent of the
legal requirement of 623,212 to avoid going to a 
prolonged full check. Sources: Secretary of State
June 9, 2020, California Stem Cell Report

The $5.5 billion initiative to save the California stem cell agency from its financial demise today made more slow progress in the official state count that is nearly certain to qualify it for the November ballot. 

The numbers already show that the measure is headed for the ballot unless something extremely unusual occurs. The California Stem Cell Report yesterday  analyzed the trends in the signature count, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 492,349 verified signatures of registered voters, up from 484,973 on Monday. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 16 counties out of 58 have not filed their verification numbers.

Look for the next update on the count tomorrow evening or early Thursday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Editor's note: An earlier version of this item said Monday's count of verified signatures was 481,689, which is actually from Friday. The correct figure for Monday is 484,973.

California's $5.5 Billion Stem Cell Countdown: Formal Upward Trend, Qualification Clearly Likely

A $5.5 billion initiative to refinance the California stem cell agency with $5.5 billion chalked up additional formal progress today, although it is clear that it will go before voters in November.

The numbers already show that the measure is virtually certain to make the ballot unless something extremely unusual occurs. The California Stem Cell Report earlier today analyzed the trends in the signature count, concluding that qualification is in the "virtual bag." The analysis also appeared on Capitol Weekly, an online California government and politics news service.

Today's figures from state officials showed 484,973 verified signatures of registered voters, up from 481,689 on Friday. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 17 counties out of 58 have not filed their verification numbers.

Look for the next update on the count tomorrow evening or early Wednesday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

(Editor's note: An earlier version said that 16 counties have not filed their verification numbers. The correct figure is 17.)

California's $5.5 Billion Stem Cell Countdown: Ballot Qualification in Virtual Bag

California Stem Cell Initiative:

Current Shortfall for Ballot Qualification

Total Raw Signatures	924,189
Total Outstanding Unverified	305,312
Total Needed Under Quickest Way to Qualify	685,534
Total  Verified	481,689
Current Shortfall	203,845

Source: California Secretary of State 6/5/2020/California Stem Cell Report

The $5.5 billion California stem cell initiative is virtually certain to qualify for the fall ballot as the arithmetic of the signature count begins to fall into place.

The measure needs only slightly more than the 67 percent of the signatures that remain to be verified as coming from registered voters. The qualification percentage of raw signatures so far is 78 percent.

It is unlikely that that the qualification rate for the remaining raw signatures would drop as low as 66 per percent unless something quite unusual occurs. Only 18 of the 58 counties have yet to verify their raw signatures, which total 305,312. The initiative needs 203,845 verified signatures to make the ballot.

The ballot initiative is aimed at saving the California stem cell agency from financial extinction. Known formally as the California Institute for Regenerative Medicine (CIRM), the agency has nearly run through the $3 billion it received from voters in 2004. Without a major cash infusion, it will begin closing its doors next fall.

The campaign is shooting for the quickest way to the ballot. It submitted 924,189 raw signatures about one month ago. Legally, the measure needs only 623,212 signatures that are verified to have come from registered voters.

However, the state permits a combination of a random and hand count total of 110 percent of that number to qualify a measure without going to a signature-by-signature verification. County election officials are currently in the combination, random sample phase of checking the signatures on the ballot initiative petition.

If the current process falls short of 110 percent, the state requires a "full check" of each signature, a task that likely cannot be completed by the state's deadline of June 25. Counties have until June 24 to report to the state. (If the percentage falls below 95, the measure will not qualify.)

See here for the state's official report on the count as of the end of work last Friday. Here are more details on how the initiative process works in California.

The California Stem Cell Report will have updated figures this evening or early tomorrow.

California Stem Cell Ballot Initiative Signature Count

Unverified/raw signatures outstanding as of June 5, 2020

County	Raw Signatures
Alameda	31,002
Butte	6,502
Contra Costa	23,167
Fresno	29,072
Inyo	610
Kings	1,756
Lake	2,088
Placer	8,343
Riverside	51,478
San Benito	485
San Diego	99,899
San Francisco	14,263
San Mateo	6,491
Santa Cruz	6,436
Solano	9,910
Trinity	142
Tulare	9,663
Yolo	4,005
Total Outstanding Unverified	305,312

Source: California Secretary of State 6/5/2020, California Stem Cell Report
(Editor's note: An earlier version of this chart listed San Joaquin in place of San Francisco.)

California's $5.5 Billion Stem Cell Countdown: 70 Percent on the Way to Making the Ballot

State election officials yesterday reported that the $5.5 billion, California stem cell initiative is 70 percent on its way to qualifying for the November ballot. 

The latest number of valid signatures totalled 481,689. The measure's backers hope that they will have 685,534 valid signatures of registered voters out of 924,189 unverified signatures they submitted nearly a month ago.

The qualification rate still stands at about 78 percent.

The proposal would save the financial life of the California stem cell agency, which is running out of money. It was provided with $3 billion by California voers who created in in 2004. It will begin shutting down this fall without substantial financial assistance.

Reporting in yesterday was Orange County. Among the larger counties not yet reporting are San Diego and Riverside.

Look for an update on the tally Monday evening or early Tuesday morning right here on the California Stem Cell Report, your source for the last 15 years for all things dealing with the stem cell agency, officially known as California Institute for Regenerative Medicine(CIRM). 

California's $5.5 Billion Stem Cell Countdown: Sixty Percent on the Way to the Ballot

The $5.5 billion, California stem cell initiative this afternoon climbed closer to qualifying for the ballot but still remains more 200,000 signatures away from going before voters in the fall. 

The measure is an effort to financially rescue the California stem cell agency, which is running out of money. It will begin shutting down this fall without substantial financial assistance. 

Today's report from state election officials showed 411,839 verified signatures out of a raw total of 924,189.  Backers of the measure are hoping for 685,534 valid signatures to avoid going to a "full check," signature-by-signature count. Such an effort in 58 counties could be so prolonged that the measure would miss the deadline for being placed on the ballot. 

The current count is a combination of a hand count and random sampling. 

State election officials have set a deadline of June 24 for counties to submit figures. The state's own deadline to complete its work is June 25.

Today's tally is 60 percent of the needed 685,534. It is 110 percent of the legally required figure of 623,212.

So far about 78 percent of the raw signatures have been verified as coming from legally registered voters. 

Still missing from the total of verified signatures are San Diego, Riverside and Orange counties, which have a total of 200,546 raw signatures. 

Look for an update on the tally tomorrow evening or early Saturday morning right here on the California Stem Cell Report, your source for the last 15 years for all things dealing with the stem cell agency, officially known as California Institute for Regenerative Medicine(CIRM).