FDA approves stem cell for first-in-human use in clinical trial

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The FDA has approved a stem cell therapy that will work to repair damage caused by heart attacks, according to a release from the California Institute for Regenerative Medicine (CIRM). The approval will be the first-in-human use for the therapy in clinical trials.

According to the release, Los Angeles-based Capricor, which uses cardiosphere derived cells, will carry out the therapy, which aims to reduce scarring and repair the cells affected by heart attack. The biotechnology company stated on its website that its research only involves adult cells.

“This is the first time that research by a CIRM-funded disease team has resulted in an Investigational New Drug approval from the FDA, a critical step in testing promising therapies in patients,” Ellen Feigal, MD, senior vice president for research and development at the stem cell agency, said in a release. “It’s a reflection of the initial progress being made in advancing scientific discoveries towards potential therapies for patients.”

The therapy was funded by CIRM with a $5.5 million disease team award that was granted to a team at Cedars-Sinai Heart Institute in Los Angeles.