The California Institute for Regenerative Medicine, or CIRM, has awarded City of Hope more than $880,000 to develop new methods for producing high-quality human embryonic stem cells.
The two-year Tools and Technologies Award will support the Center for Biomedicine & Genetics’ efforts to supply stem cells for use in preclinical research and clinical studies throughout the state.
“For the first time, we plan to grow large quantities of human embryonic stem cells that can meet the requirements of the U.S. Food and Drug Administration,” or FDA, said Larry Couture, Ph.D., senior vice president of the Sylvia R. and Isador A. Deutch Center for Applied Technology Development and principal investigator on the grant.
In late January, the FDA approved the first clinical trial of a therapy based on human embryonic stem cells. And others are soon to begin, said Couture, so researchers increasingly need a dependable, large-scale source of these cells. “The current methods of producing and storing these cells aren’t sufficient for supporting clinical studies,” he said.
Only a handful of research facilities produce human embryonic stem cells today, and those facilities focus on producing cells for use in laboratory studies rather than clinical trials. Researchers have no common standard to ensure cells’ quality and consistency, either.
Couture’s team aims to develop new ways to produce large amounts of high-quality, standardized cells. “The methods we develop and the cells we produce will benefit all investigators in the state of California,” he said. “By having centralized and accessible manufacturing capability in the state, we will be able to accelerate the progress of promising stem cell technologies into clinical reality,” said Couture.
The CIRM-funded project will focus on human embryonic stem cell lines currently approved for federally-funded research; however, Couture expects the technology to apply to all human cell lines should government restrictions on stem cell research be eased.
In August 2001, President George W. Bush prohibited any federal funding for research involving human embryonic stem cells outside of already existing cell lines. President Barack Obama is expected to loosen those restrictions.