California Institute for Regenerative Medicine


The California Institute for Regenerative Medicine was created in 2004 after 59% of California voters approved California Proposition 71: the Research and Cures Initiative, which allocated $3 billion to fund stem cell research in California.
Institutes dedicated to stem cell research and training exist at Stanford Consortium, Stanford University, University of California Davis, University of California Irvine, University of California San Francisco, University of California Los Angeles and University of Southern California. Five “Alpha Stem Cell Clinics have also been established to lead clinical trials for stem cell therapies at City of Hope, University of California San Diego, University of California San Francisco, University of California Davis and a joint clinic at University of California Los Angeles and University of California Irvine.

History

CIRM was established via California Proposition 71 however, its implementation was delayed when out-of-state based opponents incorporated in California to file two lawsuits that challenged the proposition's constitutionality. Opponents argued that the initiative created a taxpayer-funded entity not under state control, that the Independent Citizen's Oversight Committee had a conflict of interest with representatives being eligible for grant money, and that the initiative violated the single-subject requirement of initiatives by funding areas beyond stem cell research. In May 2007, the Supreme Court of California declined to review the two lower court decisions, thereby upholding Proposition 71 as constitutional and permitting CIRM to fund stem cell research in California. The Court’s decision has precedential value, meaning that it would bind a lower court if the same claims were re-asserted. The concluding paragraph of the appellate Court’s decision is as follows:
“As we indicated at the outset, our review of the various constitutional and other objections appellants have addressed to the stem cell initiative involves no normative evaluation of the merit of the measure. Nonetheless, the objective of the proposition is to find, “as speedily as possible,” therapies for the treatment and cure of major diseases and injuries, an aim the legitimacy of which no one disputes. The very pendency of this litigation, however, has interfered with implementation for more than two years. After careful consideration of all of appellants' legal objections, we have no hesitation in concluding, in the exercise of “ ‘our solemn duty to jealously guard the precious initiative power’ ”, that Proposition 71 suffers from no constitutional or other legal infirmity. Accordingly, we shall affirm the well-reasoned decision of the trial court upholding the validity of the initiative.”
In 2006, before CIRM first began funding awards, scientists were just discovering the best ways of working with stem cells or of converting them into mature cell types that would be useful as therapies. Funding restrictions from the federal government and legal concerns also prevented many scientists from dedicating their labs to regenerative medicine. As a result, few graduate and undergraduate students were learning how to work with the cells. This created a severe shortage in the future stem cell lab workforce.
CIRM realized that if the goal was to generate new therapies, the first steps would need to be supporting scientists’ entry into the stem cell research field, giving them space and adequate opportunities, to work, and ensuring a viable and healthy population of well trained and educated stem cell scientists. That’s why the first awards were dedicated to training young scientists, building new facilities and attracting California researchers into entering stem cell science, which was previously too erratically and poorly funded to attract adequate levels of talented researchers, regardless of their skill and interest.
In 2008, the agency awarded a small amount of money to encourage scientists to form teams and think about ways of turning their research into therapies, and in 2009 CIRM began investing in possible future therapies that came out of those early awards.
Some therapies that are on the path to FDA-approval of CIRM-funded research projects involve transplanting the cells themselves. Others are drugs that were discovered through modeling diseases in a petri dish, or doing accelerated or large-scale drug testing, such as the two FDA approved therapies that came from research the agency supported. Still, others will be diagnostics that allow doctors to diagnose and treat diseases more effectively—or through technologies that open up whole new fields of research. CIRM funding promotes all areas of stem cell research that show promise to accelerating treatments to patients in need.
Specific examples of CIRM funding include:
As of 2018, CIRM has invested:
In late 2019, CIRM had awarded more than $2.67 billion in grant funding across six broad categories: physical and institutional infrastructure, basic research, education and training, research translation, research application and clinical trials. By the end of 2019, CIRM had generated more than $4 billion in additional private, public and non-profit matching funds from philanthropies, universities, individual donors and private entities – more than doubling the value of California’s investment in accelerating medical research and the development and delivery of treatments and cures.
The $3 billion initially provided to CIRM through Proposition 71 was budgeted to last until 2017. In February 2014, Robert Klein, a leader in the initial campaign for Proposition 71 and former CIRM Board Chair, presented a proposal at the UC San Diego Moores Cancer Center to extend CIRM funding. Another option discussed at that time, was for CIRM to become a private, non-profit organization that would rely solely on outside funding.

Economic Impacts

In 2019, an independent Economic Impact Report conducted by the University of California Schaeffer School of Public Policy and Economics found that CIRM has had a major impact on California’s economy, creating tens of thousands of new jobs, generating hundreds of millions of dollars in new taxes and producing billions of dollars in additional revenue for the state. The report looked at the impacts of CIRM funding on both the state and national economy from the start of the Stem Cell Agency in 2004 to the end of 2018. The total impacts on the California economy were estimated to be:
In addition to the benefits to California, the impacts outside of California on the US economy are estimated to be:
Therefore, the total quantified economic impacts of CIRM on the entire U.S. economy are estimated to be:
CIRM is the only state agency that has an independent financial accountability oversight committee chaired by the state Controller that is responsible for reviewing and auditing its financial practices annually, as well as reviewing progress in public meetings. The conflict of interest provisions set by CIRM exceed the National Institutes of Health guidelines and are updated for the consideration of funding awards every four years in consultation with the National Academies of Sciences to ensure that the standards remain consistent with best practices. The Controller serves as the Committee Chair, and the remaining committee members are appointed by the Treasurer, Senate President pro Tempore, Assembly Speaker and Chair of CIRM’s Governing Board. The CIRM Board itself is comprised of members appointed by elected state officers, including the Governor, Lt. Governor, the State Treasurer, The Controller, the Speaker of the CA State Assembly and the President Pro Tempore of the California State Senate. Only one member shall be appointed from a single university, institution or entity.
CIRM is required to undergo an annual financial audit from a public accounting firm, and to provide an annual public report detailing how it has allocated its resources. It is also required to undergo a performance audit every three years to ensure operational accountability. The most recent 2018 audit found CIRM has a collaborative, engaged and performance-oriented culture, is patient-centered and has improved processes to be more efficient and effective sine the implementation of CIRM 2.0.
Some of the additional measures taken to ensure no conflicts of interest occur include:
In 2008 the Little Hoover Commission evaluated CIRM at the request of California Senators Sheila Kuehl and George Runner. The Commission commented specifically on the structure of the CIRM governance board and the need for greater transparency and accountability. The Commission provided suggestions on how to improve the structure and enhance the functioning of the CIRM board some of which included: decreasing the size of the ICOC from 29 to 15 members with four having no affiliations with CIRM-funded organizations; allowing board members to serve a maximum of four years; and eliminating the overlapping responsibilities of the agency chair and the board president. In addition, the Commission recommended that CIRM also allow outside experts to evaluate grant proposals.
CA Senator Dean Florez, Little Hoover Commission member and State Senate Majority leader at the time, was not satisfied with the report, highlighting several concerns in a letter to the Little Hoover Commission, stating: “I am concerned about the Commission's apparent rush to conclude its report. As one member said at the meeting, five minutes and a sandwich is not adequate time for Commission members to absorb the information that was presented. While I appreciate the substantial effort that Commission members and staff put into drafting the report, I am concerned that due to its rush to approve the report, the Commission gave disproportionate weight to CIRM's critics and did not consider a broader range of views on the complex issues that are the subject of the report.”
A 2008 “Review Of Conflict-Of-Interest Policies, Grant Administration, Administrative Expenses, And Expenditures,” by the State Controller’s office, which examined 18 straight months of the agency’s operations, found that “CIRM has extensive conflict-of-interest policies and processes that are modeled after and, in some instances, go beyond National Institute of Health requirements. Our conclusion is consistent with the Bureau of State Audits in its audit report of CIRM issued in February 2007.”
In December 2012, the Institute of Medicine released a report, “The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures”, that evaluated CIRM programs and operations since its start in 2004. The IOM committee made recommendations similar to those made in the Little Hoover Commission. In general, the IOM recommended that the ICOC separate their responsibilities as executor and overseer and noted potential conflicts of interest among the CIRM board members. Several active CIRM board members also represented organizations that currently received or benefited from CIRM grants. The IOM committee also recommended that CIRM organize a single Scientific Advisory Board with experts in stem cell biology and cell-based therapies.
In 2014 the integrity of CIRM's grant review process was challenged, after CIRM awarded a Stanford-led consortium $40 million stem cell genomics award, making it the largest CIRM research grant. In February 2013, CIRM reviewers evaluated applications for genomics awards but, for the first time, declined to send any grant proposals to the board for a final decision. Comments were sent back to the researchers and re-submissions were accepted in Fall 2013. During the Fall 2013 review, CIRM reviewers sent all four genomic award proposals to the CIRM board, recommending that all four projects receive funding despite the projects exceeding the budget of $40 million. The CIRM President, Alan Trounson, became involved in the selection process and the final decision was to fund the Stanford project only, totaling $40 million. The CIRM grant review and scoring process and the role of President Trounson have been questioned, especially by those that did not receive funding like Jeanne Loring from the stem cell program at Scripps Research Institute.