Friday, April 10, 2020

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.  Sphere: Related Content

Thursday, April 09, 2020

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. 

Sphere: Related Content

Wednesday, April 08, 2020

$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 Morrisonchairman 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.  Sphere: Related Content

Tuesday, April 07, 2020

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. 
Sphere: Related Content

Friday, April 03, 2020

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. 
Sphere: Related Content

Wednesday, April 01, 2020

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 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.) Sphere: Related Content

Tuesday, March 31, 2020

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

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:
Sphere: Related Content