Stem cell: $137 million buys more clinical trials, shared labs …

It was a $137 million day for the Golden States stem cell agency no small event even for an enterprise that is backed by billions.

The scientific scope covered by the $137 million was impressive. It ranged from bolstering the vauntedAlpha Clinic Networkinitiated around the state by theCalifornia Institute for Regenerative Medicine (CIRM), as the agency is legally known, to raising the number ofCIRMs clinical trials to 83. Plus, CIRM directors gave the go-ahead to a $50 million program to finance shared labs around the state.

CIRMs cash comes from $5.5 billion that voters approved in 2020. The money is borrowed by the state via state bonds. The agency, however, does not have all its boodle lying around in a vault in its South San Francisco headquarters. CIRM can only receive $540 million in bond funding annually. But the cash carries over from year to year.

CIRMs $137-million-day came on Oct. 27, a few days before CIRM officially turned 18.

Nonetheless, awarding the money sooner rather than later is in CIRMs best interest. No research is done without cash. CIRM needs to generate results that will convince voters to approve more billions in about 10 years when its funding runs out. Given the slow pace of therapy development, a decade may span only the initial steps in the process.

CIRMs $137-million-day came on Oct. 27, a few days before CIRM officially turned 18. The ballot measure that gave birth to the agency, the largest such state enterprise in the country, was approved on Nov. 2, 2004. Voters awarded CIRM an initial $3 billion, hoping for quick development of miraculous stem cell therapies available to the general public. CIRM is still working on that promise.

The biggest chunk of last months $137 million went for the Alpha Clinics $72 million on top of the $40 million already invested in the network. Continued CIRM funding of the existing Alpha Clinic sites does raise questions about the initial rationale behind network

The first request for applicationsfor Alpha clinic was posted in 2013. It said the applications would be judged on whether they present a feasible and compelling business/fundraising proposal, and the likelihood that implementation of the plan would support the Alpha Stem Cell Clinics beyond the 5-year funding provided by this RFA. Last months awards are also for five years.

One criterion considered by reviewers was whether the (UCSD) application met the needs of underserved and disproportionately affected communities.

The clinics are aimed at expanding existing capacities for delivering stem cell, gene therapies and other advanced treatment to patients, according to CIRM. They also serve as a competency hub for regenerative medicine training, clinical research, and the delivery of approved treatments.

At last months meeting, CIRM directors expanded the program to includeStanford UniversityplusCedars-Sinaiand theUniversity of Southern California, both in Los Angeles. The network already includedUCLA, UC Davis, UC San Francisco, UC Irvine, UC San Diegoand theCity of Hope.

UC San Diegos bid for $8 million more hit a roadblock, however, when it was rejected prior to the Oct. 27 board by CIRMs application reviewers, who make the de facto decisions on grants while meeting behind closed doors. The board almost never overturns a positive decision by the reviewer on applications.

The reviewers found significant flaws in the UC San Diego application (number INFR4-13597). They included criticism of the diversity plan and problems with training. One criterion considered by reviewers was whether the application met the needs of underserved and disproportionately affected communities.

In other awards, the sole clinical trial application for $12 million went toJana Portnowat theBeckman Research InstituteofCity of Hope

The review summary said that was an underdeveloped portion of the proposal. Ability to effectively increase DEI (diversity, equity, inclusion) in enrollment seems to be there but so many aspects of recruitment, retention, etc were missing.

The review summary also cited the limited number of patients enrolled clinically in stem cell and gene therapy trials.

Catriona Jamieson, director of the current Alpha program at UC San Diego, successfully appealed the rejection of the application by reviewers ina five-page, single-spaced letterto CIRM directors.

CIRM ChairmanJonathan Thomastold the board that the San Diego program, which will extend into rural Imperial County, is absolutely first rate and has produced many excellent projects.

In other awards, the sole clinical trial application for $12 million went toJana Portnowat theBeckman Research InstituteofCity of Hopefor a phase one trial involving the development of a delivery vehicle for a cancer-killing virus that targets brain tumor cells (application number CLIN2-13162 #2). It was the second try by Portnow for CIRM funding.

Another $3 million was awarded toBoris MinevofCalidi Biotherapeuticsof La Jolla, Ca., for work to initiate a clinical trial involving skin cancer (application number CLIN1-14080).

The $50 million shared labs planwas approved by directors but does not immediately involve individual awards. CIRM plans a deadline of next spring for applications. They are scheduled to be approved in late 2023.

The aim of the labs effort is to overcome hurdles in stem cell research. Not all research laboratorieshave local access to relevant infrastructure and training, nor do all have the opportunity to collaborate with a stem cell-based modeling laboratory, CIRM said in the plan proposal.

Laboratories well-versed in stem cell-based modeling that share their expertise and/or provide models collaboratively cant meet demand, as it is time-consuming and costly to divert resources to educating and supporting other researchers.

Regarding the Alpha awards, below are the names of the recipient institutions and principal scientists, along with their application numbers. The numbers are needed to locate the specific application review summaries, which do not identify the applicants. The review summaries include both positive and negative comments about the applications. All of the awards are for $8 million.All of the review summaries can be found at this link.

Cedars Sinai Michael Lewis, INFR-13586

City of Hope Leo Wang, INFR4-13587

Stanford University Matthew Porteus,INFR4-13579

UC Davis Mehrdad Abedi, INFR4-13596

UC Irvine Daniela Bota,INFR4-13952

UC Los Angeles Noah Federman, INFR4-13685

UC San Diego Catriona Jamieson,INFR4-13597

UC San Francisco Mark Walters, INFR4-13581Editors Note: David Jensenis a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report,where this story first appeared.He has published thousands of items on California stem cell matters.

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