FDA gives expanded access approval for Lomecel-B in Hypoplastic Left Heart Syndrome.- Longeveron Inc

Longeveron Inc. announced that the FDA has granted expanded access approval for the administration of Longeveron’s investigational cell therapy Lomecel-B to a child with Hypoplastic Left Heart Syndrome (HLHS). Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured under cGMP in Longeveron’s cell processing facility in Miami, Florida. Dr. Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery at Ann & Robert H. Lurie Children’s Hospital of Chicago will administer Lomecel-B during a reconstructive cardiac surgery procedure.Longeveron announced the successful completion of its Phase I clinical study of Lomecel-B intramyocardial injection in HLHS patients. The study was conducted by a consortium of leading pediatric cardiac surgeons at centers that included the University of Maryland Medical Center, University of Cincinnati/Children’s Hospital Medical Center and University of Utah Primary Children’s Hospital, and was supported in part by a Maryland Stem Cell Research Fund TEDCO Grant. The intramyocardial injection of Lomecel-B was well-tolerated, with no major cardiac events, and no serious adverse events related to Lomecel-B were reported. The Phase I safety results have enabled Longeveron to advance its HLHS program into a Phase II multi-center trial, with a randomized, double-blind, placebo-controlled trial scheduled to begin in the third quarter of 2021, and is led by Dr. Kaushal as the Principal Investigator, and funded by the National Heart, Lung and Blood Institute.