The 29-member governing board of the California
Institute for Regenerative Medicine (CIRM)adopted the plan on a 19-1 vote. The negative vote came from Joan Samuelson, who questioned
whether the plan was premature and whether existing scientific research justified development of the clinics.
Sherry Lansing, a patient advocate board member and
former head of a Hollywood studio, said the proposal is “one of the
most exciting proposals that we have ever had in front of us.” She
said it was the “beginning of this dream coming true.”
Under the far-reaching proposal, which
CIRM President Alan Trounson has been promoting for two years, the
agency will finance five stem cell clinics at established
institutions in California with grants of up to $11 million. Another
$15 million will be allotted for a stem cell information and
coordination center. Major matching contributions will be expected
from award winners over the five-year terms of the grants.
The effort is aimed at drawing in
clinical trials and patients from the around the world and creating a
central bank of knowledge, know-how and regulatory expertise. It
will also guide efforts to build profits into stem cell therapies
and to develop strategies to attract investors and philanthropists.
(For more information on the plan, see here, here, here, here and
here.)
Trounson said in a statement,
“These clinics have the potential to revolutionize how we deliver stem cell therapies to patients. Stem cell therapies are a completely new way of treating diseases and disorders so we need a completely new way of delivering those in a safe and effective manner. These clinics will help us do just that and the clinical trials carried out in this network will fulfill the agency’s promise of bringing new therapies to patients who need them.”
The journal Nature Medicine has
reported that the Alpha clinics would be the first-ever “clinical
trials network focused around a broad therapeutic platform.”
The CIRM board heard no negative
comment on the plan other than the remarks by Samuelson. . However,
not everyone sees a need for it. Mahendra Rao, director of the Center
for Regenerative Medicine at the National Institutes of
Health(NIH) , says its surveys of researchers have not shown a demand
for such centers. In May, a researcher at institution that likely
would be an applicant filed a blistering, anonymous comment on the
California Stem Cell Report, describing it as a "boondoggle" and "irresponsible." The scientist said,
“Another boondoggle for some medical schools but made to order for private operators like for-profit cancer, dialysis, and laser eye specialty clinics that do one procedure. I can see each of the medical schools gifted with one as they each were gifted with about 25 million dollars for stem cell institute buildings.”
The researcher continued,
“The NIH at various times has tried to organize clinical trials groups with infrastructure, like quick reaction forces, ready to gear up for a new trial at the drop of a hat. They mainly did nothing but suck money, kept staff employed, because there are generally few drugs ready for early human trials and each treatment that is brought along requires a unique contract, ethics reviews, and different facilities, equipment and staff than planned for. The latest incarnation are CTSAs or CTSIs, clinical and translational science centers funded by the federal NIH that most if not all California medical schools already have.”
The RFA for the proposal is expected to
go out in October and approval of funding coming one year from now. Here is the link to today's CIRM press release on the plan.
It would be nice to have an overall update on how much as been spent on California's stem cell research project and what progress has been made.
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