The California Institute of Regenerative Medicine’s board signed off on the allocation of $70M to begin setting up clinics and to bring a number of developing stem cell therapies into clinical trials.
The network, called the Alpha stem cell clinics network, will consist of five sites at established academic institutions and a coordinating center that will help streamline patient enrolment, management of regulatory procedures and data sharing.
“The vote last week was simply to approve the concept. Next we will put together a list of the criteria we are looking for in these clinics and then invite people to apply for funding to set up a site,” Kevin McCormack, spokesman for CIRM, told Outsourcing-pharma.com.
“Once we have a group of applications we'll send those out to an independent review panel of experts and they'll make recommendations about which ones to approve, and then we'll go back to our Board to get them to approve or reject those applications.”
McCormack estimated the process of reviewing the applications will take until spring of next year “and even after that it could be another year before the clinics are actually up and running.”
Possible CRO Opportunities
The opportunity to run trials under the well-funded CIRM could be a boon for CROs (contract research organizations).
Within the concept statement approved by the board, the request for application process is described as geared towards “an existing profit or non-profit CRO-like entity, with appropriate organization, management, and general expertise, and an excellent track record in seeing clinical trials in biomedical research through fruition with successful outcomes.”
But the difficulties of handling the stem cells and gathering enough patients to enrol in a trial may prove daunting for whatever company tries to conduct the trials.
“No one has reached out to us yet because the specific details of what we are looking for in the clinics have not yet been decided,” McCormack said.
“Typically companies and academic institutions interested in applying to us for funding wait until we have posted the criteria for the particular grants and then they contact us to see if they would be eligible. But that is likely to be several months away.”