Stem Cell Board Nixes $13.4 Million to Help Cure Cartilage Disorders

Directors of the California stem cell agency today rejected a $13.4 million proposal that would have been the first disease team research that it has backed that would deal with cartilage disorders.

The project would have built on earlier research funded by CIRM. The agency staff cited work at UC Davis  by Kyriacos Athanasiou and at Scripps by Peter Schultz. Funding of the application was supported by the CIRM staff, which did not identify the applicant.

However,  the governing board, however, went along, on a 10-1 vote, with arguments by Director Jeff Sheehy and others that the agency had finite resources and had to make difficult decisions. He noted that many alternative treatments exist for cartilage problems. Sheehy said,

"We are here to make progress on serious diseases and conditions."  

Former Chairman Robert Klein, in an unusual appearance as a member of the public, urged approval of the grant. He said that it would address conditions "very prevalent in the older population."  Klein told the board that the research would be a "very important milestone that will help you get more money in the future."

While Klein did not mention it, older persons participate in elections to a much greater degree than younger persons. They would be an important group in winning support for another bond issue to fund CIRM, which runs out of cash for new grants in 2017.

$13.9 Million Approved for Sickle Cell Research at UCLA

The California stem cell agency today effectively approved a $13.9 million grant involving UCLA to develop stem cell gene therapy for sickle cell anemia.

CIRM directors acted on a staff recommendation to place the grant in a category that is automatically approved by the board.

(Here is a press release that was issued later by UCLA. The investigator is Donald Kohn.)

CIRM Directors Reject $16 Million Eye Research Application

Directors of the California stem cell agency today rejected a $16 million application from Cedars-Sinai for research involving retinitis pigmentosa.

The action came on a split vote despite a personal appearance by the principal investigator, Kent Small, and a patient advocate.

CIRM staff had recommended rejecting the grant because the agency is funding a number of other eye research projects. The vote was 7-4 to approve the staff recommendation.

Small and Clive Svendsen, also of Cedars-Sinai, noted that other diseases have many grants from CIRM and have not been subjected to the same sort of objection. They noted that the eye is a particularly good target for stem cell therapy compared to other areas of the body.

$4.4 Million Grant Approved for Severe Airway Obstruction

The governing board of the California stem cell agency today effectively approved a $4.4 million grant for research involving severe airway obstruction.

The board approved a staff recommendation to place the grant in a category that the board automatically votes to fund. Names of the applicant and employer have not been released by the agency.

Disease Team Applications Under Discussion

The $100 million disease team round applications are under discussion currently at today's meeting of the governing board of the California stem cell agency.

CIRM Chairman Jonathan Thomas outlined the appeal process prior to the discussion and cautioned rejected applicants in the audience that the board is not the first avenue of appeals.

The board has revised its appeal process in the last year to discourage appeals directly to the board.  Over the last couple of years, the appeals have often involved emotional presentations by patient advocates seeking to support applications.

Nonetheless, under state law, any person has a right to address the board on any subject.

CIRM Board Meeting Begins in Los Angeles

Directors of the California stem cell agency opened their meeting at 9:08 a.m. PST today with a presentation on the annual audit.

Live Coverage Upcoming of CIRM Board Meeting: Presidential Selection, $100 Million in Grants on Table

The California Stem Cell Report will provide live coverage of today's meeting of the governing board of the $3 billion California stem cell agency beginning at 9 a.m. PST.

Directors are scheduled to approve criteria for selection of a new president and award roughly $100 million in their ambitious disease team program, which is aimed at pushing stem cell research closer to the marketplace.

Here is a link to the agenda, which has background material on most of the items.

Sharp Exchanges as Stem Cell Board Tables Future Funding Proposal

A plan to finance the California stem cell agency after its $3 billion runs out in 2017 was shunted aside today after it ran into sharp opposition and questions from several of the agency's governing board members.

Vice chairman Art Torres attacked the preparation of the report as "offensive" because none of the patient advocates on the board, of which he is one, were consulted in its preparation. He said the CIRM staff should have prepared the $150,000 report -- not a consultant. Torres said the issue of sustained funding for the agency is the responsibility of the Chairman Jonathan Thomas, not the outgoing President Alan Trounson.

Torres' heated remarks drew a sharp retort from Trounson, who summarized the report for the board and said it was part of his management goals. Trounson said that he considered Torres' remarks an "attack on me," an assertion that Torres denied.

Other board members, including Thomas, said the report requires further thought and testing. They said the new president, who will replace Trounson, should be involved. CIRM Director Jeff Sheehy, another patient advocate, moved to table the report and put it in the hands of Thomas with the proviso that no further funds be spent on it pending further action. Sheehy's motion was approved on a voice vote.

The report was aimed at dealing with the loss of state bond funding for the agency.  The report called for private-public partnerships that would mean closer ties to industries. The funding would undoubtedly be considerably less than the $300 million or so that the agency currently hands out annually.

The proposal would also mean a considerable change in the nature of CIRM's program, likely focusing even more on research that is close to the marketplace.

Another bond issue for funding the agency has not been ruled out by the agency. But taking it to the voters is difficult politically and financially. The initiative campaign in 2004 that created the stem cell agency cost more than $30 million.  Stem cell scuttlebutt has it that former CIRM Chairman Robert Klein is talking up another bond election and perhaps even raising campaign funds.

Here is a link to Trounson's Power Point presentation today.

New Funding Plan for Stem Cell Agency Coming Up Shortly

Next up before the California stem cell agency board of governors is the proposal for a public-private funding plan to carry the research forward after 2017, when its current funding runs out. The board is on a short break and will resume in about five minutes.

Stem Cell Lab Program Nixed in California

Directors of the California stem cell agency today eliminated future funding for a $72 million "shared" labs program that supporters said was a key to successful stem cell research in the Golden State.

The action came on a 4-0 vote with two abstentions following a presentation by 20 stem cell scientists that the labs were vital to research and needed for the training of scientists. Jeanne Loring, head of the Scripps stem cell program, told the board today that the labs have evolved to become the place "where all of the research for CIRM takes place." She later said in an email that each lab is currently receiving only $200,000 a year.

The agency's Scientific Advisory Board recommended no further funding of the labs, saying their original justification was no longer "compelling." CIRM staff agreed, saying alternatives to shared labs were available.

CIRM President Alan Trounson said the agency had a finite number of dollars and "sometimes we have to cut off some these things." He said that the labs are "probably not as important as some other things" and that the labs are a "luxury."

The labs have another six to 12 months of remaining funding. Steve Juelsgaard, a CIRM board member, said the labs should have been planning for a loss of funding from the agency.

Only seven of the 29 members of the agency governing board could participate in the discussion or vote because of conflicts of interest. One of the seven was absent from the meeting. The other members of the board are tied to institutions that operate shared labs.

The program was begun in 2007 and has been funded to the tune of $72 million since then. Loring later said in an email to the California Stem Cell Report,

"You should mention that each of the shared labs was getting $200,000 a year…that's it. That's what they decided to cut.  We have leveraged that money 10-fold from NIH, but NIH will not support cores directly."

(Loring's comments in her email were added following publication of the original version of this story.)

California Stem Cell Agency: $200 Million Approved to Speed Up Stem Cell Cures

The California stem cell agency today set aside $200 million to accelerate research into early stage clinical trials over the next several years.

The plan was unanimously approved as directors considered ways to generate therapeutic results as they strive to fulfill promises made to California voters in 2004 when they approved creation of the $3 billion research effort.

Ellen Feigal, senior vice president for research and development for the agency, told directors that about 14 existing projects would be examined for acceleration with possibly up to six to eight ultimately selected. The grants review group would consider the projects, and its recommendations would be brought to the governing board for final approval. One key criteria would be the likelihood that the trial would demonstrate proof of concept by 2017. (See here for her presentation and full criteria for selection.)

The $200 million set aside would go for possible phase two clinical trials. Some directors said more money was needed because costs generally rise. Additionally stem cell research is a new field and is likely to be more expensive than conventional research. The agency would also beef up support for the projects with more advice from external advisers and CIRM staff.

Funding for the agency is set to expire in 2017, and the agency is seeking results that will support a drive to raise additional cash.

California Stem Cell Meeting: CIRM Directors Decide to Press Harder on Therapy Development

Directors of the California stem cell agency today voted to intensify their focus on a handful of projects most likely to advance through clinical trials despite concerns that other efforts by the agency could suffer as a result.

On a unanimous roll call vote, the board approved a motion to create a priority system as recommended by its new Scientific Advisory Board.

"It is time for us to be brutal," said CIRM Director Sherry Lansing, a former Hollywood studio chief and former chair of the University of California board of regents. She said,

"Unless we have a home run in something...it will be extremely difficult to get more funding."

The agency is expected to run out of cash for new grants in 2017. It is in the process of trying to devise a plan for some sort of private-public financial partnership. Discussion at the meeting also made it clear that another bond ballot measure has not been ruled out by some directors, who emphasized the need to show results to voters.

Several directors expressed concern that by making a decision to establish priorities the agency would be forgoing efforts to create "the strongest possible foundation" for stem cell science. They questioned whether the agency should behave like a business "trying to hit a home run." However, no votes were registered in opposition to setting priorities.

During this morning's meeting in Los Angeles, CIRM staff briefed directors on the status of CIRM research. The governing board was told that six to eight projects could be selected out of 23 with the goal of accelerating them into phase one and phase two clinical trials.

A figure of $200 million was mentioned as a possible set aside to help the projects move ahead, but the directors this morning did not approve a specific amount. That may come later today.

Several directors commented that today's meeting on priorities and future funding plans may well be the most significant in years.

The board is now at lunch.

California Stem Cell Meeting Resumes

Directors of the California stem cell agency have returned from their break following repairs to their audiocast on the Internet. Discussion of the priorities of the agency is continuing.

California Stem Cell Agency: The Search for More Cash

Directors of the California stem cell agency have mentioned the possibility of cancelling some RFAs for grant rounds that have not yet moved forward as they consider ways to raise cash for additional endeavors.

The governing board is in the midst of a discussion of the agency's priorities and how to raise money for its operations beyond 2017, when cash for for new grants runs out.

The board has taken a short recess while equipment is installed to improve the quality of the Internet audiocast, most of which has been inaudible so far.

California Stem Cell Meeting: Technical Difficulties with Web Audiocast

Alan Trounson, president of the California stem cell agency, is discussing proposals for new directions at the agency at its governing board meeting this morning in Los Angeles. However, his comments are all but inaudible on the Internet audiocast of the meeting.

We have queried CIRM concerning the problem.

Stem Cell Board Meeting: Future Priorities Discussion Underway

"We're down to our last $600 million," said the chairman of the California stem cell agency this morning as he introduced a discussion of future priorities for the research effort.

Jonathan Thomas, head of the governing board, introduced the subject and outgoing President Alan Trounson to kick off what promises to be a very lengthy briefing by CIRM staff, coupled with discussion by board members.

Prieto on the Future of Stem Cell Therapies

One of the longtime directors of the California stem cell agency has commented on “The Elusive Stem Cell and the Power of Hope” item on Monday, which noted that fully tested stem cell therapies are still far from the marketplace.

Francisco Prieto, a Sacramento physician who has served on the CIRM board since 2004, said in an email yesterday,

“The advantage of being an old(er) doctor: I can remember the early 1980’s, when monoclonal antibodies had been identified and there was a great deal of excitement about the potential they held for treating previously untreatable diseases. It took a couple of decades, but these 'biologicals' have indeed become routine parts of medical therapy.  It may take a while yet, but I fully expect that we will see the same thing happen with stem cell based therapies.”

Cash to Cures: California's Stem Directors Begin Today's Meeting

Directors of the $3 billion California stem cell agency this morning began a key meeting in Los Angeles as they pursue new directions and more cash to continue their efforts beyond 2017.

The two-day meeting also will see action on about $100 million in awards in the agency's ambitious disease team round, which is aimed at pushing research into clinical trials. Additionally on tap is discussion of the search for a new president.

Bloomberg: California Stem Cell Cash Shrinking, Pressure for Results

The headline this morning on Bloomberg News read “California’s Stem-Cell Quest Races Time as Money Dwindles.”

 The status report on the $3 billion California stem cell agency came as its 29 directors meet in Los Angeles today to consider new directions for the agency – not to mention finding a source to replace the funding which runs out in 2017. (Live coverage of the meeting will begin at 9 a.m. PST on the California Stem Cell Report.)

 The article by Mark Melnicoe is a rare national/international look at the Golden State's unprecedented, nine-year-old effort to turn stem cells into cures, as the agency's motto goes. The California Institute of Regenerative Medicine (CIRM), the formal name for the agency, is largely ignored by the national media. California news outlets also devote few resources to covering agency matters.

Melnicoe's piece covers familiar ground for readers of California Stem Cell Report and others familiar with the agency. But it is a valuable tool for understanding how “outsiders” may view the effort.

Melnicoe wrote,

“California’s government-run stem-cell research agency, on course to spend $3 billion in taxpayer money to find treatments for some of the world’s most intractable diseases, is pushing to accelerate human testing before its financing runs out.”

He continued,

“The largest U.S. funding source for stem-cell research outside the federal government, it’s under pressure to show results to attract new money from pharmaceutical companies, venture capitalists or even more municipal bonds. 

“'We need to figure out how to keep them going,' said Jonathan Thomas, a founding partner of Saybrook Capital LLC in Los Angeles, and chairman of the institute’s board, which meets today. 'We could do public-private partnerships, venture philanthropy, a ballot box.'” 

The Bloomberg article also sounded a cautionary note. It said,

“Brock Reeve, executive director of the Harvard Stem Cell Institute, said a rush could waste money by going too far down paths with false promise. 'There have been a lot of clinical trials in the stem cell field broadly that haven’t panned out,' Reeve said.” 

Specifically mentioned in the Bloomberg piece was the clinical trial by Geron, the first in the nation of an hESC therapy, which was partially financed with a $25 million CIRM loan. The trial was abandoned by Geron, which then sold its stem cell assets to Biotime, an Alameda, Ca., firm, whose top executives come from Geron. Biotime has not resumed the trial.

California Stem Cell Researchers Fight for Shared Labs

Twenty California stem cell scientists are seeking to save the state's heralded, $72 million “shared” stem cell lab program, arguing that it is vital to research and necessary for the continued training of scientists.

The researchers made their appeal in a letter (full text below) expected to be presented tomorrow to the governing board of the $3 billion stem cell agency, which funds the effort. The agency's new Scientific Advisory Board (SAB) has recommended the program be discontinued and more emphasis placed on a handful of clinically oriented projects.

In a very brief recommendation that has been accepted by CIRM staff,  the advisory board said that “the importance of these resources to the mission of CIRM and achieving sustainability of earlier investments is not as compelling (as when the program began).

The SAB continued,

“These resources should operate on a revenue-neutral basis through recharge mechanisms and gain other needed support from the host institutions.” 

The lab program began as a $50.5 million effort in 2007 and was given an additional $21.5 million in 2011 after CIRM staff cited its "exceptional" performance. Former CIRM Chairman Robert Klein praised the effort, citing its ability to leverage funding. He said,

“The $4 million awarded, for example, to Stanford for its shared lab have enabled its scientists to successfully compete for $35 million of grants from numerous sources, with another $15 million in process.”

Responding to the SAB recommendation, supporters of the labs said that without them, “development of protocols for generation of clinically needed cell types will not be possible.” Their letter said the 17 labs have been “vital to current and future CIRM-funded efforts.” There is “no alternative place' for the type of research underway at the labs, said the scientists.

The researchers signing the letter were from institutions throughout the state, including UCSF, Stanford, UC Berkeley, USC, UCLA, Salk, Scripps, Sanford Burnham, UC Irvine and UC Santa Barbara.

The letter, which was made available to the California Stem Cell Report,  said,

“In the worst case scenario, the loss of indirect cost support to the institutions will mean that the core lab space will be reallocated (a certainty for many independent research institutes), effectively dismantling the Shared Laboratories and putting CIRM equipment into storage. Shared Laboratory personnel provide support not only for the millions of dollars of CIRM purchased equipment, but often also the additional equipment that has been funded by other sources as a result of the CIRM infrastructure investment but often also the additional equipment that has been funded by other sources.... 

“Even in the best cases, there will be no means to support the staff and maintain the equipment. Some institutions may be able to provide space without indirect costs, but will not fund personnel and equipment maintenance. Thus, the original CIRM investment in infrastructure will be lost, and CIRM’s highly successful training programs for new workers (CIRM Bridges and Training Grants), will be left without homes.”

Here is the full text of the letter and a summary of survey of activity at the shared labs.

California Scientists Back Endangered Stem Cell Lab Program

Survey on California's Shared Stem Cell Lab Program posted by DavidJensen