Looking For Ways to Avoid the Stem Cell Egg Problem

A $25 million proposal to develop new lines of pluripotent human stem cells, including ones that do not require the use of human embryos or eggs, will come before the Oversight Committee of the California stem cell agency next week in San Diego.

The plan calls for as many as 16 research grants for periods of three years. Funding could come as early as next spring with the release of RFAs as early as this fall.

A CIRM staff report said,

"The ability to derive pluripotent stem cells from new sources will enable scientists to generate disease-specific and genotype-specific cells of many phenotypes. Such cells have great value for drug discovery and understanding specific disease mechanisms. Importantly, methods that will not require the donation or use of either human embryos or eggs will significantly reduce the moral and ethical concerns that surround methods currently in use. Finally, new methods of producing pluripotent stem cells will be particularly important because it may be difficult to obtain excess embryos from many racial groups.

"This RFA will support the generation of new lines of pluripotent human stem cells including:

"• new clinical grade lines of hESCs and other pluripotent human stem cells suitable for future clinical use or other biomedical applications

"• new hESC lines generated using improved methods that may be optimal for differentiation along selective lineages or for studies of disease

"• disease-specific, pluripotent stem cell lines to support the study of the effects of genetic variation on disease development and response to treatment

"• the discovery and implementation of alternative methods for generating pluripotent human cells"

The report also said,

"Awards will be made to support two areas of derivation: the generation of new human lines using excess embryos from in vitro fertilization, and derivations from other sources using new and novel methods."

$122 Million Disease Team Proposal

Preliminary plans for an innovative research effort that could possibly even involve scientists from outside California will be aired publicly at a meeting next Wednesday of the Grants Working Group of the California stem call agency.

The Disease Team initiative is part of CIRM's strategic plan, which was approved last year. That document said the initiative is designed to organize "the highest quality basic, translational and clinical research with the specific aim of producing a therapy for a particular disease or group of diseases whose research is poised for development of therapies."

The plan said out-of-state activities could be included if funding were available from other sources. The initial grants would total about $100,000 each and go for one-year planning efforts. Later grants would run as high as $20 million over eight years. Total size of the program is estimated at $122 million.

Next week's session in San Francisco is aimed at generating input from members of the Grants group, the public or other interested parties. Planning grants are likely to go out next year.

CIRM Grant Oversight Question

Lawrence Ebert has posted the following question:

"Of the procedure on grants given by CIRM, I was wondering "who" has the authority to conduct oversight. Directly, this comes up as to "who" might have been responsible for vetting the Cha proposal. Down the road, "who" would conduct any investigation of alleged research impropriety. In a different research area, this issue is currently looming large. See
http://ipbiz.blogspot.com/2007/03/more-about-congress-reviewing-purdue.html

"Separately, how much of the CIRM grants are going directly to the conduct of research, and how much are going to overhead of the respective institutions?"

Here is what we know. Re the questions of oversight of grants given by CIRM, it is CIRM itself that has oversight and the agency vets the proposal and monitors its execution. It is unclear who might conduct an investigation of research impropriety beyond CIRM, although the state Department of Justice has wide authority to investigate and prosecute violations of state law. CIRM's research regulations have the force of law.

We can't tell you the split on overhead vs. actual research, but we learned at the March 15 meeting of the Oversight Committee that comparing size of NIH grants and CIRMs for the same project is not accurate. CIRM grants apparently include funds that are not usually included in the announced figures for equivalent NIH grants.

The $80 Million Stem Cell Grant Proposals

The public summaries and scores of the applications for $80 million in embryonic stem cell research grants are now available on the web site of the California Institute for Regenerative Medicine.

You can find them directly by using this URL: http://www.cirm.ca.gov/publicsummaries/RFA_06-02/PublicList.html.

The grant recipients will formally be approved next Friday at the meeting of the CIRM Oversight Committee in Los Angeles.