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# FDA Approves Celixir IND for Cell Therapy for Heart Failure
- URL: https://www.fdaweb.com/fda-approves-celixir-ind-for-cell-therapy-for-heart-failure/
- Published: 2018-06-08T12:00:00.000Z
- Updated: 2026-09-15T00:11:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141645

FDA has approved a Celixir IND for Heartcel, an immuno-modulatory progenitor (iMP) cell therapy for treating adult heart failure. The tissue-engineered product comprises allogeneic (off-the-shelf) iMP cells, which are a novel cell type engineered to reduce heart scarring and regenerate the heart in patients with heart failure, the company says. iMP cells are currently delivered during coronary artery bypass graft, but catheter delivery is in development to expand the indication to all heart failure and cardiomyopathy patients, the company says. “Heartcel Phase 2 results presented at the 2016 International Society of Stem Cell Research Annual Conference showed the study met all the endpoints with statistical and clinically significant results,” it says. Twelve-month endpoints included 100% major adverse cardiac event-free survival, 30% average improvement in left ventricular ejection fraction, 40% reduction in left ventricle scar size and 50% improved quality of life. The IND approval allows the expansion of an international trial in the U.S.