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FDA Approves Clinical Trials for Stem Cell Treatment of Heart Attacks

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The therapy, which will be taken forward by Los Angeles-based biotechnology company Capricor, uses cardiosphere derived cells (CDCs) to reduce scarring and repair the damage caused to heart muscle by a heart attack. The cells are found in heart tissue and have the potential to change into a variety of different heart cell types.

Eduardo Marbán, MD, PhD, Director of the Cedars-Sinai Heart Institute, led the research into the therapy. Dr. Marbán said, "By funding our preclinical studies on adult stem cells from the heart, CIRM has shown its commitment to developing practical, here-and-now treatments. In the next phase of clinical testing we hope to achieve the shared goal of making regenerative medicine a reality for the millions of patients afflicted by 'irreversible' heart disease."

The Disease Team Awards fund research that includes basic scientists and clinicians from both academia and industry. The goal is to create collaborations that will speed up the process of moving promising therapies from the lab into clinical trials by insuring that clinically relevant issues are considered early and avoiding potential safety issues being discovered late in the process.

"This is the first time that research by a CIRM-funded Disease Team has resulted in an Investigational New Drug (IND) approval from the FDA, a critical step in testing promising therapies in patients," says Ellen Feigal, MD, CIRM's senior vice president for research and development. "It's a reflection of the initial progress being made in advancing scientific discoveries towards potential therapies for patients."

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