Supporters of $5.5 Billion California Stem Cell Measure Miss Third Deadline, Including One Recommended by the State

Backers of a $5.5 billion, California stem cell research proposal this morning once again missed their self-imposed, but important deadline for qualifying the measure for the ballot this fall in hopes of saving the financial life of the state stem cell agency. 

It was the third time that the ballot initiative campaign has missed its own deadlines for gathering signatures as time is running out. The first deadline was April 11. The second deadline was April 18. The third deadline was April 21 (yesterday). The next deadline is April 23 (tomorrow).

Yesterday was also the deadline recommended by state election officials for submitting the signatures to all of California's 58 counties.  The state's recommendation is not a legal cutoff, but appears aimed at ensuring enough time exists to complete the lengthy certification process for the November ballot.

The proposed ballot initiative would refinance the state stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM). It is running out of its original $3 billion and is expected to begin closing its doors next fall. 

The campaign, which is independent of the agency, had little to say about its signature-gathering problems. The California Stem Cell Report this morning asked the campaign how many signatures it has on hand.  Sarah Melbostad, a spokeswoman for the campaign, replied:

"They are still in the process of counting them but we will let you know as soon as we have an updated number to share."

It was not clear whether the campaign actually knows how many signatures it currently has or whether, on the other hand, it has an actual number but is simply not releasing it publicly. The campaign did not respond to a question this morning on that matter. 

Several weeks ago, the campaign said it had 915,000 signatures. That was when it set its April 11 deadline to secure 35,000 more. It needs only 623,212 to qualify for the ballot, but many signatures are disqualified as elections official in each county checks to see whether the signatures represent actual registered voters. 

Melbostad said, 

"We’re continuing to get petitions in the mail every day from our patient advocacy-driven and direct-mail signature gathering efforts. The campaign is planning to submit signatures to the counties in the next two weeks to ensure that the counties and the state have sufficient time to count and verify signatures for the November ballot."

If election officials have not certified the necessary signatures by June 15, the stem cell measure will not appear on the ballot. The certification process can be prolonged and likely more so under the difficult conditions imposed by the coronavirus crisis. 

State election officials provide recommended deadlines under normal conditions for submitting petitions to qualify ballot measures. They depend on the method used for qualification: random sampling or "full check." Under the random sample method, the recommendation is to submit petitions to county election officials by yesterday (April 21). Under the full check method, March 3 was the recommended deadline. 

Two Deadlines Missed by Supporters of $5.5 Billion, California Stem Cell Measure

Backers of a $5.5 billion stem cell research proposal in California today have once again missed a self-imposed, but critical deadline as they continue to struggle with securing enough signatures to place the measure on the November ballot.

The campaign's website this morning listed what is now its third deadline for gathering the signatures of 950,000 voters. Previously, the campaign had set an April 11 deadline and then an April 18 deadline. The latest deadline is tomorrow (April 21). The rolling extensions do not augur well for its "unprecedented" attempt to collect signatures via a combined online and mail-in effort. 

In response to questions from the California Stem Cell Report, Sarah Melbostad, a spokeswoman for the campaign, declined to elaborate on the campaign's progress or lack of it beyond a statement she released on Friday.

The questions ranged from just how many signatures the campaign currently has in hand to when they might be presented to election officials. (Here is a link to the text of all the questions.)

The campaign's ballot initiative is aimed at staving off the financial demise of California's stem cell agency, which has all but run out of the $3 billion that it was provided by voters in 2004, also through a ballot initiative.  Known formally as the California Institute for Regenerative Medicine (CIRM), the agency has no other significant funding source than state-issued bonds.

The coronavirus crisis has blocked the usual method of gathering of ballot initiative signatures at shopping malls and other public locations. The campaign said earlier it needed another 35,000 signatures to hit its goal of 950,000. The legal requirement is only 623,212 but many signatures are disqualified as invalid, sometimes as high as 50 percent.

Another obstacle involves officials in the state's 58 counties, who must certify the signatures. Most, if not all, are short-staffed because of the coronavirus and/or must provide a working environment that is likely to slow the signature count. If the count is not completed by June 15, the stem cell measure will not be on the November ballot and the agency will begin closing its doors.

Text of Questions to Campaign for $5.5 Billion Stem Cell Intiative

Here are the questions that the campaign for a $5.5 billion California stem cell research measure declined to address this morning. The questions were directed to the campaign by the California Stem Cell Report last Friday in connection with the campaign's then April 18 deadline for collecting signatures to qualify the measure for the fall ballot. 

• How many signatures have been gathered for presentation to election officials? Is that number based on an estimate or actual count?
• The campaign has said it has "no estimates to share." Does that mean that, in fact, it has estimates that it does not want to share? Is the campaign keeping a rolling total of signatures each day since it began its new mail-in effort?
• When will the petitions be presented to election officials?
• How long does the campaign think the count will take?
• Does the campaign plan to try to gather more signatures either beginning this week or after it receives information about the disqualification rate?
• Is there anything else I need to know?

Correction

A item earlier today dealing with the signature-gathering campaign for a $5.5 billion ballot measure incorrectly said that the campaign had said it had gathered 935,000 signatures. The correct figure is 915,000.

$5.5 Billion California Stem Cell Proposal: Campaign Mum on Its Ballot Qualification Numbers

Backers of a $5.5 billion, proposed ballot measure said this morning that they still cannot provide a fresh estimate of the number of voter signatures they have in their effort to save the California stem cell research program from financial extinction.

The campaign faces a self-imposed deadline of Saturday to gather the needed signatures in its initiative petition drive, which was stymied when the coronavirus crisis hit the Golden State.  While the deadline is self-imposed, it reflects the upcoming, tedious and time-consuming pace of signature verification by county election officials, who are additionally hampered by workplace restrictions currently in place.

If county officials have not verified 623,212 signatures of registered voters by June 15, the stem cell initiative will not be placed on the ballot. The campaign has said early this month that it has 915,000 signatures and needs to collect a total of 950,000 by tomorrow. That reflected a slippage from last Saturday on an earlier deadline. 

The excess beyond 623,212 is needed because high percentages of signatures are determined to be invalid in normal petition circulation efforts, sometimes as high as 50 percent.

Responding to questions from the California Stem Cell Report, the campaign released a statement this morning that said, 

"The campaign is receiving petitions in the mail every day, however it takes time to count and verify incoming petitions. 

"While we don’t have an estimate to share, we do know that over the last week website traffic has increased, with more than 10,000 people visiting our signature gathering page....

"The campaign is aiming to give the counties as much time as possible to verify signatures. However, the landscape is changing on a daily basis, and adapting to new challenges during these uncertain times requires nimble decision-making and flexibility."

The state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), is running out of the $3 billion it was originally provided in 2004. That was when another ballot initiative created the agency, supporting it with state bond funding. The agency has no other significant source of cash. CIRM could have asked the legislature and the governor for more financial support earlier, but such an effort would have faced a difficult political road. 

Without additional funding, the agency will begin to close its doors next fall. 

Other ballot initiatives are facing the same signature-gathering pressures in California and elsewhere in the country. The Guardian newspaper in the United Kingdom carried a piece yesterday looking at the issues throughout the United States. It quoted a backer of one initiative effort in California to permit collection of signatures for future initiatives electronically as saying, "It's a killer. We're done."

See here for the exact process of verifying signatures and certifying a measure for the ballot.

Correction: An earlier version of this item incorrectly said that the campaign had said that it had gathered 935,000 signatures. The correct figure is 915,000.

Info Sources on Stem Cells and Covid-19

A California stem cell blog is digging into research involving cell therapies aimed at the coronavirus, and this week it posted a summary of the work that is underway from Texas to Israel.

The blog is called The Niche and is produced by UC Davis stem cell researcher Paul Knoepfler. On Monday, he posted a quick look at six efforts. He also has probed claims involving Rudy Giuliani. On Tuesday, Knoepfler recommended a comprehensive view of of Covid-19 efforts published by the Alliance for Regenerative Medicine, an industry group.

From the East Coast, STAT news has made its impressive coronavirus coverage available free online. STAT's stories are generally several cuts above, in terms of quality, most of the mainstream media. The STAT coverage explores more deeply many of the scientific issues along with how the work is financed and carried out by biomedical companies, including stem cell approaches. Here is a link to the STAT coronavirus lineup. 

Time Running Out for $5.5 Billion California Stem Cell Ballot Initiative

Backers of a proposed $5.5 billion, stem cell ballot initiative are pressing on with their cyberspace campaign to assure that the measure will qualify for the November ballot despite "a landscape (that) is changing on a daily basis."

But as the campaign's website notes, "Time is running out."

No fresh figures for the number of signatures have been released since early this month. The campaign has also extended to this Thursday its self-imposed deadline for collecting 950,000 signatures. The campaign originally hoped to have the signatures in hand last Saturday.  

At stake is the financial life of the California stem cell agency, which is running out of money and is expected to begin the process of closing its doors next fall unless it receives an infusion of cash. The ballot initiative needs 623,212 signatures of registered voters to make the November ballot.  At last report, it had 935,000. However, the disqualification rate of signatures on petitions can run as high as 50 percent. 

County election officials are also working under Covid-19 conditions, which can mean a reduced work force and limited hours for verifying signatures. At some point, moreover, the mechanics of printing and delivering the ballot information that must go to nearly 20 million voters come into play for state election officials. 

Responding to a query from the California Stem Cell Report, campaign spokeswoman Sarah Melbostad released a statement yesterday that said:

"This new virtual signature gathering effort was launched just last week, and as it takes time to count the incoming signatures by mail, we do not have an updated number to share. 

"The campaign is aiming to give the counties as much time as possible to verify signatures, however the landscape is changing on a daily basis, and adapting to new challenges during these uncertain times requires nimble decision-making and flexibility. 

"Voters can continue to visit our website https://caforcures.com/help-us-qualify/ to sign the petition and learn how they can help ensure the continuation of treatments and cures that could save or improve the lives of millions."

The stem cell measure is not the only initiative that is facing problems. It could well be that the governor may take some sort of emergency action to extend deadlines for all of them. 

Earlier this month, the stem cell campaign launched an "unprecedented" electronic, mail-in effort to gather the final number of signatures that were judged to be needed. It is a daunting process to conduct online and then have the petitions returned in the mail. 

The campaign web site stresses the urgency and pressing need for more signatures. "The campaign must gather the last 35,000 signatures through mail-in submissions by April 16th," the web site says. 

Covid-19 and California Stem Cell Agency: Plasma Research to be Funded in $5 Million Round

California's stem cell research agency, in an "emergency" move this morning, joined the search for a plasma treatment for Covid-19, stressing the importance of extending access to minority communities. 

It was only the second time in the 15-year history of the agency that its governing board invoked its "vital research opportunity" clause, which gives it authority to divert funding from stem cell research to other purposes.

Maria Millan, CEO and president of the agency, said in a statement,

“The intent behind this amendment is to be responsive to this COVID-19 crisis by leveraging CIRM’s funding programs, processes and infrastructure within the scientific ecosystem that it has supported to date.

"By providing an opportunity for the medical and scientific community to gather important data while using convalescent plasma treatment protocols on an emergency basis, CIRM is joining the global effort to  expedite treatments to patients in need in the midst of this global pandemic."

This morning's action, approved unanimously, adds plasma research to a $5 million grant round aimed at the coronavirus.  The round has rolling application deadlines. The first was last Tuesday and drew 19 applications. The next deadline is expected in about two weeks.

The board unanimously added a provision to the plasma proposal aimed at ensuring that it would reach into minority and medically under served areas of the state. 

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), is speeding its award process and expects winning applicants to be ready to begin their work within 30 days of approval of an award.

The use of plasma in treating Covid-19 has attracted international attention as well as here in California.   

CIRM directors also approved additional members to its panel of grant reviewers, all of whom come from out-of-state. The agency selects reviewers from the panel depending on the nature of their expertise. 

Here is a link to the CIRM news release on the action today.

California Stem Cell Agency Set to Finance Anti-Covid-19 Plasma Research

In a rare move, California's stem cell agency is set to expand beyond its traditional scope and finance research involving the use of blood plasma for treatment of Covid-19 patients. 

It would be only the second time that the agency, known formally as the California Institute for Regenerative Medicine (CIRM), has invoked the "vital research opportunity" clause in the 10,000-word ballot initiative that created the agency in 2004. 

Under the initiative, CIRM is restricted to using its $3 billion for stem cell research -- not the vast array of possibilities for the entire field of biomedical research. But a little-noticed provision also allowed for exceptions in the case of "vital research opportunities."  

The proposed action tomorrow would include plasma research in a new, $5 million effort approved two weeks ago to support stem cell research involving Covid-19. On Tuesday, the agency received 19 applications for funding under that fresh, ongoing effort. Another deadline for applications is expected in about two weeks. 

The expansion to include plasma will be presented to the CIRM governing board tomorrow at 11 a.m. PDT during a public, online meeting. It includes funding "proposals to study convalescent plasma or its derivatives (e.g., immunoglobulin) for the treatment of patients with COVID-19."

The plan also said,

"Clinical studies of convalescent plasma may propose use of the FDA’s single-patient emergency IND (eIND investigational new drug) pathway to satisfy the (agency's) CLIN2 eligibility requirements for a traditional IND."

CIRM's $5 million coronavirus effort might seem skimpy to those used to thinking of the agency as a $3 billion program. It was a $3 billion effort 15 years ago. Today the agency is running out of cash and is down to its last $27 million, which is largely committed to a sickle cell round. 

CIRM is hoping that a proposed, $5.5 billion ballot initiative will qualify for the November ballot, be approved by voters and give it at least another 10 years of life.  

The first occasion for invoking the "vital research" clause involved gene therapies. 

The public can listen in on tomorrow's meeting and make comments. Instructions for online access can be found on the meeting agenda. 

Here is a look at a national plasma effort already underway. Here are federal recommendations concerning such research. 

$5 Million Allotted: California Stem Cell Agency Receives 19 Applications for Research Targeting Covid-19

Nineteen scientists seeking to crush the coronavirus submitted applications this week for research grants from the California stem cell agency, which has set aside $5 million for the job. 

Details on the nature of the proposed work were not disclosed by the agency, known formally as the California Institute for Regenerative Medicine (CIRM). That's in keeping with its usual practice concerning applications that are yet to be reviewed or approved. 

The research must involve a stem cell or a drug or antibody targeting stem cells. The agency said that only research involving "development or testing of a treatment for Covid-19 (is) eligible."

The "emergency" coronavirus round was established by the agency just two weeks ago. CIRM plans to deliver funds quickly to the winning applicants. The researchers are expected to be ready to begin work within 30 days of approval of the awards. 

The agency allocated the $5 million on March 27. Yesterday was the first deadline for applications. The next is expected in about two weeks.  The agency has said it would fund all stages of research from basic to clinical. Maria Millan, president and CEO of the agency, said earlier in a statement, 

“These are clearly extraordinary times and they require an extraordinary response from all of us.... California researchers have made us aware that they are pursuing potential stem cell based approaches to the COVID-19 crisis, and we felt it was our responsibility to respond by doing all we can to support this research and doing so as quickly as we possibly can."

Some scientists have expressed doubt that a stem cell approach can generate the results needed. In posting Sunday on The Niche stem cell blog, Sean Morrison, chairman of the Public Policy Committee at the International Society for Stem Cell Research and director of Children’s Research Institute at University of Texas Southwestern, responded to a question that asked about "potential roles for cellular therapies for COVID-19? Is there something unique they might be able to achieve that other approaches like anti-viral drugs could not?"

Morrison replied,  

"I’m afraid I’m skeptical about cellular therapies for Covid-19. Some have suggested that transplantation of immune effector cells, such as NK cells, into patients might promote a more effective immune response. I worry it will take too long for the transplanted cells to engraft and mount an effective immune response against a virus that often kills patients within days of hospitalization. 

"Others have suggested that mesenchymal stem cell (MSC) transplants might provide a benefit by attenuating the hyper-inflammation that occurs in late stage patients. While there has been some evidence that MSCs can attenuate pathological immune responses in some contexts, most clinical trials that tested this strategy failed. The other red flag is that all of the cell therapies I have seen proposed for Covid-19 have been repurposed from very different indications.

"To some extent that’s to be expected when dealing with a novel pathogen. However, it gives one pause when a cell therapy under development for cancer is suddenly touted as also having anti-viral activity. Immunologically, these are two very different problems that require very different kinds of pre-clinical testing."

The next step in CIRM's Covid-19 round is for the agency to convene a panel of scientists from out-of-state to review the applications behind closed doors and make the de facto decisions on whether to fund them. Their decisions then go to the CIRM governing board for ratification. 

At that point, summaries of the anonymous reviewers' comments on the applications become public. 

Five of the applications were from private companies and the rest from nonprofits. 

The reviewers do not publicly disclose their financial or professional conflicts of interest. Members of the governing board are barred from voting on applications involving their institutions. The research is required to be performed in California. 

A Grim Picture? Nuts and Bolts of California's Ballot Petition Pinch and $5.5 Billion for Its Stem Cell Research Program

Here is a not-so-hypothetical question: In these days of the coronavirus crisis, is it safe to touch a mailed-in petition to place a $5.5 billion stem cell research proposal on the November ballot?

While some may consider the question dubious, it is in, in fact, a real question for enterprises attempting to win a position on the ballot next fall. And it illustrates the difficulties facing backers of the proposed stem cell ballot measure, which is aimed at saving California's stem cell agency from financial extinction. 

The agency is running out of money and will begin to close its doors next fall unless more cash is coming in.

Lisa Renner wrote yesterday about California's ballot petition pinch for Capitol Weekly, a respected online news service that follows state governmental and political affairs. She said,

"It’s never easy to get initiatives qualified for the ballot, but this year of the COVID-19 pandemic is the worst ever....

"While organizations technically have until April 21 to turn in signatures to qualify for the November ballot, the shutdown effectively means that those that didn’t collect enough signatures by mid-March probably won’t make it. At best they can hope for possibly qualifying for November 2022."

Renner painted a vivid picture of the nuts-and-bolts of the petition business. She quoted Fred Kimball, owner of Kimball Petition Management.

"Kimball is faced with the challenge of confirming the signatures to make sure they are from unique registered voters. In a normal year, he said he has 75-100 people crammed in his office checking signatures. But this year, he has only six workers in house while the rest are looking at petitions from home.

"'I haven’t done this ever,' he said. 'Usually the petitions never leave the site of the office. There’s a lot of trust you put into the workers. It’s very difficult.'

"Some employees have quit because they don’t want to touch papers that have been handled by so many people and thus could be contaminated with the virus. To deal with that concern, Kimball has set a new rule that new signatures pages that come in his office must sit for one week before anyone touches them again. He also requires employees in house to wear masks and gloves."

Kimball's firm is working on the ballot proposals dealing with kidney dialysis and medical negligence. But his comments bear on any proposed initiative. 

In the case of the stem cell measure, it needs 623,212 valid signatures of registered voters to qualify for the ballot. Backers say they have 915,000 and need another 35,000 in order to account for disqualified signatures. They have launched an ambitious and "unprecedented" effort to circulate petitions via the Internet.

"Proponents usually seek at least 50 percent more than the legal minimum number of signatures to compensate for possible duplicate or otherwise invalid signatures," according to Wikipedia.

Capitol Weekly's Renner also reported on the stay-at-home orders facing county elections officials.

"Most have shut down all offices, requiring initiative supporters to set up appointments to drop off petitions. Much of their staff is also working at home, which sets up the new burden of getting the petitions to employees."

She continued,

"Joseph Holland, the Santa Barbara County clerk, recorder, assessor and registrar of voters, said his office hasn’t even finished certifying the March 3 election and is facing employees out sick and suddenly charged with taking care of their children after schools closed. “We are operating with a skeleton crew,” said Holland, who also serves as president of the California Association of Clerks and Elections Officials. 

"While his employees are considered essential under the shut-down order, figuring out logistics about where they sit is an issue. They can no longer sit side by side at cubicles as that would violate the 6-foot social distance rule. “It has reduced our capacity by half.” 

"For petition signatures that come in on a single page, the county is able to scan them and electronically send them to employees working at home for validation. But the county is not able to scan petitions that come in booklet form. Those must still be validated by employees at the office, Holland said."

The verification process involves random samples, which can trigger a full check of each signature, slowing the process considerably. There is a possibility that the current legal requirements could be modified, but that change would likely involve the governor and the legislature. 

The campaign for the stem cell measure has set for itself a deadline of this Saturday to finish collection of signatures. 

Final Cyberspace Dash Underway for $5.5 Billion California Stem Cell Initiative

Above is the instructional video from the stem cell initiative campaign web site. 

The campaign to save California's stem cell research program from financial extinction is making an "unprecedented," electronic sprint to gather the final signatures to qualify its $5.5 billion rescue measure for the November ballot. 

In the next eight days, the campaign says it needs 35,000 more signatures to be sure that the multi-billion-dollar ballot initiative is presented to voters next fall. 

The stem cell agency, officially known as the California Institute for Regenerative Medicine (CIRM), is running out of money. It will begin closing its doors in November without more funding.  The campaign's web site says, 

"Over 915,000 voters have already signed petitions to help qualify our initiative for the November 2020 ballot. In the last full week before public signature gathering was shut down due to the coronavirus, over 120,000 voters signed – a tremendous response. But we need at least 950,000 signatures to secure a place on the California ballot this fall. 

"Help us meet our goal by signing and returning a petition today. The campaign must gather the last 35,000 signatures through mail-in submissions by April 11th."

In response to questions from the California Stem Cell Report, campaign spokeswoman Sarah Melbostad described the online move as "unprecedented." She said,

"What’s happening right now across the world is unprecedented, which means the innovative changes we’re making to gather signatures through a mail-in option are unprecedented as well." 

The campaign's unusual Internet pitch is aimed at putting petitions in the hands of its supporters. The effort requires downloading documents, reading detailed instructions on filling them out and then returning them by regular mail. Normally, paid signature gatherers take care of all that.

The process is not simple and is likely to be daunting for some.  The campaign's web site mentions "wet signatures," the importance of printing out the 16 pages of the petition and the need to complete the "circulator declaration." A seven-minute instructional video has also been posted by the campaign (see above). 

The campaign's message stresses speed. 

"Time is of the essence; a fast response is needed to preserve our opportunity to guarantee our ballot position."

The legal minimum of valid signatures of registered voters is 623,212. The extra hundreds of thousands of signatures are needed because many are disqualified by election officials during the certification process.

The campaign's online pitch also includes a schedule of 30-minute webinars aimed at building support and answering questions. They begin tonight at 6:15 p.m. PDT and continue on April 5, 7 and 11. 

Backers of a $5.5 Billion California Stem Cell Measure Claim 915,000 Signatures, Ballot Qualification at Stake

The campaign to place a $5.5 billion, stem cell measure on the California ballot this fall says it has gathered more than enough signatures to bring it before voters. 

In response to questions from the California Stem Cell Report, a campaign spokeswoman said,

"In our last full week of signature gathering, we received 120,000 signatures, showing the tremendous support from California voters. With 915,000 signatures in hand and a new sign-from-home option that allows individuals to mail in their signatures, we’re confident that we will be able to gather the final signatures we need while, most importantly, keeping Californians safe." 

The proposal needs 623,212 valid signatures of registered voters to qualify. Because so many signatures are disqualified in the verification process, many more than the bare minimum are required. 

The next step is for the campaign to submit the signatures to election officials for verification, a process than can take a month or more under normal government operating conditions. 

The entire process has a deadline of June 15 to be completed.  

Campaign spokeswoman Sarah Melbostad said, "Voters can go to our website caforcures.com to sign the petition and ensure the continuation of treatments and cures that could save or improve the lives of millions."  

(Editor's note: An earlier item on this subject that was briefly up this afternoon  incorrectly said that the campaign had not responded to a question concerning the current number of signatures. That post has been deleted.)

California Pumps $5 Million into Search for Stem Cell Treatment for Covid-19

Coronavirus

California's stem cell agency, in an emergency action, has allocated $5 million for research into treatments for Covid-19 and set the deadline for the first applications for one week from today. 

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), approved the funding last Friday during an emergency meeting of its governing board. 

In an item yesterday on the CIRM blog, Maria Millan, CEO and president, said,

"California researchers have made us aware that they are pursuing potential stem cell based approaches to the Covid-19 crisis, and we felt it was our responsibility to respond by doing all we can to support this research and doing so as quickly as we possibly can."

The agency set accelerated timetables for action, both by the agency and applicants. It said it would expect winning applicants to begin work within 30 days of being approved. 

CIRM's move comes as itself is facing a mortal financial threat. It was created by voters CIRM in 2004 with $3 billion. It is now down to its last $27 million and is hoping voters will approve $5.5 billion more via a proposal that is yet to qualify for the November ballot. Otherwise CIRM's doors will begin to close in the fall. 

Presumably, billions of private and public dollars are already pouring globally into the search for various aspects of Covid-19, so the $5 million is a relatively tiny amount. CIRM has developed a speedy process, however, for bringing funds to bear on research and is acting to accelerate that even further. 

Jonathan Thomas, chairman of the CIRM board, said, 

"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." 

The campaign to qualify the $5.5 billion initiative for the ballot released a statement heralding the action by CIRM. Robert Klein, the Palo Alto real estate developer behind both the original ballot measure and this year's funding initiative for CIRM, said, 

"The investment by California’s stem cell institute to combat Covid-19 highlights the remarkable potential of this research and therapy development to impact the lives of every Californian. ...We urge Californians to think back on this moment, when they decide the fate of future life-saving stem cell discoveries and treatments come November."

The campaign said 10 days ago that it has suspended the gathering of signatures. It is not clear whether it has enough to qualify for the fall ballot. More than 600,000 valid signatures are required. 

Here are links to additional CIRM information on its Covid-19 program:

• Concept statement
• Application information and timetables
• Presentation slides from last week's meeting
• CIRM's news release

Covid-19 Break for California Stem Cell Report

The California Stem Cell Report, at least this writer, has tested positive for covid-19.  The symptoms are such that it makes it make difficult to compose even short postings. We are following the usual precautions and hope to return to regular publication soon.

California's $5.5 Billion Stem Cell Initiative: Signature Gathering Suspended Due to Coronavirus

Backers of a $5.5 billion stem cell research initiative in California have suspended their efforts to gather signatures to place it on the November ballot, but are expressing confidence that the proposal will qualify.  

In response to questions from the California Stem Cell Report, the campaign said it had run afoul of statewide bans on public gatherings. Voter signatures on petitions to place the initiative on the ballot generally require small gatherings in public places. 

The proposal is intended to refinance the California stem cell agency, which has spent nearly all of the $3 billion it was provided by voters in 2004. It will begin to close its doors next fall unless more funding is provided. 

Sarah Melbostad, a spokeswoman for Californians for Stem Cell Research, released a statement that said, 

"In keeping with the governor’s statewide order for non-essential businesses to close and residents to remain at home, we’ve suspended all signature gathering for the time being."

The statement continued, 

"We’re proud of our team and proud of the promising and significant number of signatures we’ve gathered to date – demonstrating strong support amongst voters. We’re confident that we still have time to qualify and plan to proceed accordingly."

To qualify for the ballot, the valid signatures of 623,212 registered voters are needed. Large numbers of signatures are usually disqualified during the certification process. So tens of thousands of signatures or more beyond the minimum are invariably necessary. 

The campaign originally expected to have the signatures gathered by the end of April. The campaign did not respond to a question concerning the number of signatures that it has on hand now. 

The California Stem Cell Report understands that petition circulation companies throughout the state are calling in their signatures next week. At that point, reliable figures may be available. The halt to signature gathering affects other potential ballot measures this fall. 

Here is the full text of the campaign's statement:

"In keeping with the Governor’s statewide order for non-essential businesses to close and residents to remain at home, we’ve suspended all signature gathering for the time being.

"As the COVID-19 issue is updating daily, if not hourly, we at the campaign are monitoring the situation very closely and will comply with all statewide, regional and local ordinances.

"We’re proud of our team and proud of the promising and significant number of signatures we’ve gathered to date – demonstrating strong support amongst voters.

"We’re confident that we still have time to qualify and plan to proceed accordingly.

"When faced with this current situation, we’re reminded every day how important this initiative is to save and improve the lives of millions of Californians living with chronic diseases and conditions, such as cancer, Alzheimer’s, heart disease, HIV/AIDS, kidney disease and more."

Coronavirus Fallout: New and Bigger Hurdles Now Face $5.5 Billion California Stem Cell Measure

California's intensifying battle against the coronavirus is creating ever larger obstacles and uncertainty concerning the proposed $5.5 billion ballot initiative to refinance the state's stem cell research program, which is running out of money.

The new, statewide ban on public gatherings is certain to hamper the gathering of the 600,000-plus signatures needed to place the measure on the November ballot. No one knows how long that ban will be in place. Signature gathering in California largely occurs in public places using paid workers. 

The financial fallout from the crisis also raises questions about whether funds can be raised to support the petition drive -- not to mention a fall ballot campaign that could cost in the neighborhood of $50 million. The usual contributors to such an effort are likely to feel financially squeezed, plus they may be refocusing on new and higher priorities dealing with health care, if they have cash they are willing to contribute.

The impact of the coronavirus crisis has already knocked off one ballot measure in Palo Alto, a wealthy Silicon Valley enclave.  The school board there this week removed a $16-million-a-year property tax measure from its May ballot.  An article in the Palo Alto Daily Post said, 

"'In order to do even a high-polling ballot initiative … the committee doing it needs to have a certain amount of resources, including money raised and feet on the street,' (school) trustee Melissa Baten-Caswell said. 'It is really not conceivable that they’re going to have enough to run the rest of the campaign in this time frame.'

The financial squeeze is also being reported nationally. Some big national political donors backed the measure that created the stem cell program 15 years ago.  Politico wrote just this morning,

"Campaigns across the country have canceled face-to-face fundraisers for the foreseeable future and are scrambling to figure out how to raise enough money to stay solvent. Big donors' stock portfolios are tanking. And small-dollar, online contributors — who have never been more important to campaigns — are facing sudden financial uncertainty and the real possibility of unemployment."

Backers of the $5.5 billion stem cell initiative have until June 15 to complete the qualification process, which goes beyond simply gathering signatures. They must be verified by election officials as valid signatures of registered voters which can take some time. 

The campaign had expected to submit more than enough signatures by late April. The California Stem Cell Report has queried the campaign for comment, but has received none. 

The stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM), was created in 2004 by voters with $3 billion in funding. It is now down to it last $27 million for awards. 

Autism and Stem Cells: Live Online Event Tomorrow from California Stem Cell Agency

The California stem cell agency wrote this week about the "definitely strange" and challenging times, but it is making a move tomorrow to stay on balance with an online Q&A exploration of autism and stem cell research. 

The specific matter is a Facebook Live event called "Ask the Stem Cell Team About Autism" at 12 p.m. tomorrow.  The agency said on its blog:

"The event features Dr. Alysson Muotri from UC San Diego. We have written about his work with stem cells for autism in the past. And CIRM’s own Associate Director for Discovery and Translation, Dr. Kelly Shepard."

Kevin McCormack, senior director of communications at the agency, said that some people had asked why the agency was going ahead with the program.

"It’s a good question. And the answer is simple. Because there is still a need for good, thoughtful information about the potential for stem cells to help families who have a loved one with autism. And because we still need to do all we can to dispel the bad information out there and warn people about the bogus clinics offering unproven therapies.

"In many ways Facebook Live is the perfect way to deliver this information. It allows us to reach out to large numbers of people without having them in the same room. We can educate not contaminate."

McCormack noted,

"If you can’t tune in while we are live, not to worry, you’ll be able to watch it again afterwards when it gets posted to our CIRM Facebook page."

Coronavirus Shutdown Hits California's Stem Cell Agency; Effort to Re-finance Research Program Hampered

California's $3 billion stem cell agency closed its physical doors this morning to avoid being considered, along with thousands of other San Francisco Bay Area enterprises, an "imminent threat to public health" under the terms of strict, new government orders. 

Maria Millan, CEO and president of the Oakland-based agency, told her 34 employees yesterday that the action was being taken in compliance with legal orders issued by six Bay Area counties. The agency's staff will continue their work from home or elsewhere.

The stringent directives affect seven million people and businesses ranging from retail to entertainment. But many enterprises were exempted because of the services or goods they provide, such as supermarkets and banks. 

Violation of the orders is deemed to be "an imminent threat to public health," a formidable piece of legalese that can be enforced by police. 

The orders generally ban public gatherings, which would seem to mean effectively a ban in the Bay Area on public gathering of signatures to qualify a $5.5 billion stem cell research measure for the November ballot. The agency is running out of money and hopes to stave off its financial demise with approval of the measure next fall. 

The deadline for completing the tedious qualification process for the ballot measure is June 15. Backers of the measure had hoped to have more than enough signatures by the end of April. 

Yesterday's orders are in effect until at least April 7.

As a practical matter, the process of soliciting signatures for ballot measures in California was already encountering barriers because of safe distance and other concerns. 

The campaign  has not yet responded to questions concerning the impact of coronavirus situation. 

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), had already allowed its employees to work from home. The agency funds research but does not actually perform it. 

Americans for Cures, a Palo Alto patient advocacy group supporting the measure, said it would be working remotely in compliance with the new orders. The group was founded by Robert Klein, who oversaw preparation of the proposed stem cell initiative.

The agency says that none of its current portfolio, which includes 60 clinical trials, has specific application to the coronavirus. Here is the text of the note that Maria Millan, CEO and president of CIRM. sent to the agency's team yesterday.

"As we enter week two of our agency-wide telecommute, the COVID-19 crisis continues to intensify, resulting in additional containment measures with an increasing number of school, university and business closures, cancellation of gatherings, and severe travel restrictions. In addition, a three week 'shelter in place' order has just been issued for six counties in the Bay Area- San Francisco, San Mateo, Santa Clara, Alameda, Marin, Contra Costa. As stated last week, this situation remains fluid, we are monitoring it closely and I am remaining in close contact with the LT, HR and our Board so we can continue to take appropriate action as needed.

"We are committed to working with our community to deploy containment measures in order to 'flatten the curve' of this outbreak and, as always, we are committed to the health and well-being of our employees and their families. In this spirit, and taking into account the containment response timing in our local communities, we will extend the CIRM agency-wide telecommute plan to April 13 . We will be in constant contact and will notify you of any additional changes. To date, there have been no documented or reported COVID-19 cases or exposure in CIRM employees.   "Thank you for continuing our important work at CIRM, for your responsive support of our programs/grantees/patient advocates during this crisis and for continuing to execute our strategic goals. I’d like to acknowledge our IT department who have armed us with the technological tools to work remotely, our project managers for coordinating us and keeping the schedules on track and leadership for enabling their teams to remain productive. "Please feel free to contact your manager, HR, Maria B or me if you have any questions related to CIRM’s COVID response or if you need assistance in transitioning to the agency-wide CIRM telecommute plan. "Take good care & look forward to working with you from a distance (for now)."

Fresh Hurdles for $5.5 Billion Stem Cell Measure: Coronavirus and Safety Distance

Signature gathering -- Too close for safety?  Photo Hero Images

The current coronavirus emergency and the practice of social distancing are likely to put a crimp in gathering signatures to qualify a $5.5 billion stem cell initiative for the November ballot in California.

The situation is already troubling much smaller petition efforts in New York State where state legislative candidates need as few as 500 signatures to qualify for the ballot.

One candidate going door-to-door reported that a resident shouted through a window, 

“I don’t want to talk to anybody or open the door!” 

In California, 623,212 valid signatures are needed to put the $5.5 billion stem cell proposal on the ballot. Backers had hoped to have well over that by the end of April.

Without voter approval of the measure, the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), will go out of business. It was created by voters in 2004 with $3 billion but is running out of money.

Other major ballot proposals are also caught in the safety distance pinch. The include ones dealing with sports betting, dialysis clinics, packaging waste reduction and a measure to modify Prop. 13, the property tax law of 1978.

Whether they are affected in a significant way depends on individual deadlines and how many signatures they have to date. Gathering signatures for a ballot measure is an expensive proposition that requires hiring signature gathering firms that, in turn, hire the "gatherers" to be in places with high pedestrian traffic. The signing process also requires what some persons might regard as less than safe physical distances in supermarket parking lots and other locations. Shoppers may well be more focused on stocking up rather than signing up. 

In New York state, Gov. Andrew Cuomo has sharply reduced the amount of signatures required for candidates to qualify for the ballot.  

In a statement, Cuomo said,
"Public health experts have been clear that one of the most common ways to communicate COVID-19 is through direct person to person contact, and we are doing everything in our immediate power to reduce unnecessary interactions.

"This executive order modifies the election process in a way that both protects public health and ensures the democratic process remains healthy and strong regardless of the ongoing pandemic."

Any impediments to gathering signatures in California are likely to mean increased expense. In 2018, costs ran as high as $9 a signature. 

It is not clear that the California governor or other state officials can do anything to deal with the slowdowns in signature gathering, which affect other efforts besides the stem cell initiative. However, state lawmakers might be able to make an immediate change in state law with a two-thirds vote of both houses and the agreement of the governor. 

To make the November ballot, the stem cell initiative campaign must clear the certification process by June 15.  The campaign did not immediately respond to a request for comment.