Stem cell scientists in California who have benefited from a $3 billion state research agency created in 2004, at the height of federal limits on working with cells from human embryos, have long known that it would eventually run out of money. That reality set in last month, when the California Institute for Regenerative Medicine (CIRM) in Oakland announced it is no longer taking grant applications.
Ongoing payments for approved projects continue, but scientists are already tightening their belts for a funding gap. They are also contemplating the end of a boom in stem cell research in the state. California’s voters may be asked to renew CIRM with another bond initiative next year, “but there’s no guarantee,” says Arnold Kriegstein, who heads a stem cell center at the University of California (UC), San Francisco, and has received CIRM funding in the past.
Longtime CIRM grantee Jeanne Loring, who retired in June from the Scripps Research Institute in San Diego, California, and runs a biotech startup to advance one of her projects, says the agency has made the state the “center of the stem cell universe. It would be tragic to unravel [that infrastructure] now. But the funding in 2004 was so dependent on the politics and interest at the time, and I don’t know if those circumstances can be replicated.”
That year 59% of California voters approved CIRM, which had been placed on the ballot as a response to restrictions imposed by then-President George W. Bush’s administration on the use of federal funding for studies of stem cells derived from human embryos. At the time, the National Institutes of Health (NIH) could only fund work on a small number of preexisting human embryonic cell lines. (Former President Barack Obama’s administration later lifted those restrictions.)
CIRM initially expected to focus on human embryonic stem cells, but later expanded its remit to more specialized adult stem cells such as those that form blood or the increasingly popular induced pluripotent stem (iPS) cells, created by reprogramming adult cells to an embryolike state. CIRM’s money led to the creation of major stem cell centers in California and lured several biotech companies to set up shop in the state. Although CIRM supported infrastructure, basic research, and training early on, in the past 3 years it has poured most of its remaining $759 million into clinical trials—a total of 55 of which are ongoing or completed to date—as the agency faced pressure to produce the medical treatments its supporters were initially promised.
In a memo to its board released on 20 June, CIRM said it had received applications totaling $88 million in its latest funding call but had only $33 million left to distribute. The agency announced the next day that it was taking no new grant applications as of 28 June, aside from a sickle cell disease program jointly funded with NIH. “There is no money available for new projects,” CIRM communications director Kevin McCormack wrote in a 1 July blog post.
Some researchers who explore the basic science of stem cells had already been looking for other funding sources as CIRM began to emphasize clinical work and their support wound down. But others, especially those planning clinical trials, will be hit hard. “It’s going to be a huge impact on my lab and many others if they end,” says April Pyle of UC Los Angeles (UCLA), whose 11-person group works on using muscle stem cells to treat muscular dystrophy. Her last CIRM grant ends in March 2020 and although she also has some NIH funding, it does not support the animal testing and other studies needed to move her work toward a clinical trial.
Future clinical work will face “at best significant delays, and many projects to identify new therapies will stop” if the agency doesn’t continue, says gene therapy researcher Donald Kohn, who heads several such trials at UCLA.
CIRM’s efforts to raise $200 million in bridge funding from private sources have been unsuccessful to date. Now, CIRM boosters are looking to a $5.5 billion bond initiative that real estate developer Robert Klein, who led the original push to create the agency, hopes to add to the November 2020 ballot.
If approved, “We would hope there would be very little gap” in funding, McCormack says. But if the voters reject the initiative, he expects CIRM’s staff to dwindle and the agency to fold by about 2023.