:en:California Institute for Regenerative Medicine

CIRM was established via California Proposition 71 (2004). However, its implementation was delayed when out-of-state based opponents incorporated in California to file two lawsuits that challenged the proposition's constitutionality.Varney, Sarah. "Court Challenge Stalls Calif. Stem Cell Funding". NPR. Retrieved 24 March 2014. Opponents argued that the initiative created a taxpayer-funded entity not under state control, that the Independent Citizen's Oversight Committee (ICOC) 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.{{Cite journal |last1=Adelson |first1=Joel W. |last2=Weinberg |first2=Joanna K. |date=March 2010 |title=The California Stem Cell Initiative: Persuasion, Politics, and Public Science |journal=American Journal of Public Health |language=en |volume=100 |issue=3 |pages=446–451 |doi=10.2105/AJPH.2009.168120 |pmid=20075315 |issn=0090-0036|pmc=2820047 }} 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.California Family Bioethics v. California Institute for Regenerative Medicine, 55 Cal Rptr 3d 272 (Cal App 1 Dist 2007).

Examples of CIRM funding include:

• In 2018, UC San Francisco (UCSF) received a $12 million grant to study severe combined immunodeficiency (SCID).{{Cite web|date=2018-04-30|title=Stem cell agency okays $32 million in new awards|url=https://capitolweekly.net/stem-cell-agency-okays-32-million-new-awards/|access-date=2020-07-28|website=Capitol Weekly|language=en-US}} The research UCSF was able to conduct due to the funding the institution received contributed in part to a potential cure in 2019,{{Cite web|author=Jacqueline Howard|title=Doctors develop 'cure' for babies with 'bubble boy' disease|url=https://www.cnn.com/2019/04/17/health/bubble-boy-disease-cure-study/index.html|access-date=2020-07-28|website=CNN|date=17 April 2019 }} described in a study published in the New England Journal of Medicine: Lentiviral Gene Therapy Combined with Low-Dose Busulfan in Infants with SCID-X1.{{Cite journal|last1=Mamcarz|first1=Ewelina|last2=Zhou|first2=Sheng|last3=Lockey|first3=Timothy|last4=Abdelsamed|first4=Hossam|last5=Cross|first5=Shane J.|last6=Kang|first6=Guolian|last7=Ma|first7=Zhijun|last8=Condori|first8=Jose|last9=Dowdy|first9=Jola|last10=Triplett|first10=Brandon|last11=Li|first11=Chen|date=2019-04-18|title=Lentiviral Gene Therapy Combined with Low-Dose Busulfan in Infants with SCID-X1|journal=New England Journal of Medicine|volume=380|issue=16|pages=1525–1534|doi=10.1056/NEJMoa1815408|issn=0028-4793|pmc=6636624|pmid=30995372}}
• In 2017, CIRM awarded $2 million to a University of California San Diego scientist searching for a cure for the Zika infection. Research resulted successfully finding a pre-approved drug to block Zika virus replication and infection, as well as transmission from mother to child.{{Cite web|last=cirm_2.0|date=2020-07-28|title=A treatment for Zika virus infection and neuroprotection efficacy|url=https://www.cirm.ca.gov/our-progress/awards/treatment-zika-virus-infection-and-neuroprotection-efficacy|access-date=2020-07-28|website=California's Stem Cell Agency|language=en}}
• In 2011, CIRM awarded $25 million to support a spinal cord injury trial – the first award dedicated to a human clinical trial – to Geron Corporation,{{Cite web|last= |first= |date=2011-05-04|title=Stem cells: CIRM funds Geron Corp. spinal cord injury trial|url=https://www.latimes.com/health/la-xpm-2011-may-04-la-heb-stem-cells-cirm-geron-trial-20110504-story.html|access-date=2020-07-28|website=Los Angeles Times|language=en-US}} which was later taken up by Asterias Biotherapeutics.{{Cite press release |title=Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury |url=https://www.prnewswire.com/news-releases/asterias-biotherapeutics-announces-notice-of-grant-award-with-cirm-for-phase-12a-clinical-trial-of-ast-opc1-in-complete-cervical-spinal-cord-injury-743675515.html |language=en |access-date=2020-07-28 |website=www.prnewswire.com}} The clinical trial led to significant benefits to a paralyzed high school student, Jake Javier, who was able to regain function in his upper body.{{Cite web|title=Jake Javier|url=https://blog.cirm.ca.gov/tag/jake-javier/|access-date=2020-07-28|website=The Stem Cellar|language=en}}

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.{{Cite web|title=California Stem Cell Agency Put $15 Billion into U.S. Economy (1)|url=https://news.bloomberglaw.com/health-law-and-life-sciences/california-stem-cell-agency-put-15-billion-into-u-s-economy|access-date=2020-07-28|website=news.bloomberglaw.com|language=en}}

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.Fikes, Bradley (20 February 2014). "$5B initiative proposed for stem cell research". The San Diego Union-Tribune. Retrieved 8 April 2014.[https://www.sandiegouniontribune.com/business/biotech/sdut-robert-klein-cirm-stem-cell-billion-2016-2014feb20-story.html] Another option discussed at that time, was for CIRM to become a private, non-profit organization that would rely solely on outside funding."The Case for CIRM 2.0: Continuing California's Stem Cell Leadership". Knoepfler Lab Stem Cell Blog. 31 October 2013. Retrieved 8 April 2014.[https://ipscell.com/2013/10/my-case-for-cirm-2-0-continuing-californias-stem-cell-leadership/]

In 2020, as CIRM's funding from the 2004 Proposition 71 was expiring, another ballot measure, Proposition 14, was advanced in California to add an additional $5.5 billion to CIRM, to enable it to continue its mission.{{cite news|last=Myers|first=John|date=November 4, 2020|title=California voters embrace special rules for app-based drivers, reject rent control plan|work=Los Angeles Times|location=Los Angeles, CA|url=https://www.latimes.com/california/story/2020-11-04/california-november-2020-statewide-propositions-election-results}} The measure passed with 51% of the vote, and so the CIRM will continue operating.{{Cite web|title=California Proposition 14, Stem Cell Research Institute Bond Initiative (2020)|url=https://ballotpedia.org/California_Proposition_14,_Stem_Cell_Research_Institute_Bond_Initiative_(2020)|access-date=2020-11-22|website=Ballotpedia|language=en}}

The CIRM Board is composed 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.{{Cite web|title=Codes Display Text|url=https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=HSC&division=106.&title=&part=5.&chapter=3.&article=1.|access-date=2020-07-29|website=leginfo.legislature.ca.gov}}

The most recent 2018 audit{{Cite web|last=|first=|date=|title=CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE FY 2016-2017 Performance Audit|url=https://www.cirm.ca.gov/sites/default/files/files/agenda/180318_Agenda_Item_8_CIRM%202017%20Performance%20Audit%20Report%20FINAL%203-2-18v2.pdf|url-status=live|archive-url=https://web.archive.org/web/20180429004447/https://www.cirm.ca.gov/sites/default/files/files/agenda/180318_Agenda_Item_8_CIRM%202017%20Performance%20Audit%20Report%20FINAL%203-2-18v2.pdf |archive-date=2018-04-29 |access-date=|website=}} found CIRM has a collaborative, engaged and performance-oriented culture, is patient-centered and has improved processes to be more efficient and effective since the implementation of CIRM 2.0.{{Cite web|last=aholden|date=2015-01-09|title=CIRM Opens New On-Line Application Portal|url=https://www.cirm.ca.gov/about-cirm/newsroom/press-releases/01092015/cirm-opens-new-line-application-portal|access-date=2020-07-29|website=California's Stem Cell Agency|language=en}}

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.Little Hoover Commission (25 June 2009). "Stem Cell Research: Strengthening Governance to Further the Voters' Mandate" (PDF). Retrieved 1 April 2014. 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.”Florez, D. (2009, July 6). California State Senate Senator Dean Florez, Majority Leader [Letter to Chairman Daniel Hancock]. Sacramento, CA.

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.”Chiang, J. (2008). California Institute for Regenerative Medicine (CIRM) Review Report: Review of Conflict-of-Interest Policies, Grant Administration, Administrative Expenses, and Expenditures (pp. 1-26, Rep.). Sacramento, CA: California State Controller.

In December 2012, the Institute of Medicine (IOM) 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.{{Cite book |url=http://www.nap.edu/catalog/13523 |title=The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures |date=2012-02-27 |publisher=National Academies Press |isbn=978-0-309-26590-4 |location=Washington, D.C. |doi=10.17226/13523}} 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.Jensen, David. "California's $40 Million Stem Cell Genomics Award: irregularities, Complaints and Integrity". Retrieved 8 April 2014. 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.Jensen, David (10 February 2014). "Amid Allegations of Unfairness, California's Stem Cell Agency Begins Examinations of $40 million Genomics Award Round". Retrieved 8 April 2014.[https://californiastemcellreport.blogspot.com/2014/02/amid-allegations-of-unfairness.html]

{{reflist}}

• [http://www.cirm.ca.gov California Institute for Regenerative Medicine homepage]
• [https://caforcures.com/ Californians for Stem Cell Research, Treatments and Cures homepage]

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{{DEFAULTSORT:California Institute For Regenerative Medicine}}

Category:Government agencies established in 2005

Category:Medical research institutes in California

Category:Research institutes in the San Francisco Bay Area

Institute for Regenerative Medicine

Category:Stem cell research