Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, announced today that the U.S. Food & Drug Administration (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.
FDA’s Expanded Access program, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. The Lurie Children’s Hospital Internal Review Board (IRB) also reviewed and approved the protocol.
Dr. Kaushal was the first surgeon in the United States to administer allogeneic MSCs to a baby with HLHS. "The rationale for this approach is to improve the functioning of the right ventricle, the only ventricle in these babies, through regeneration of cardiac tissue. Our goal is to make it pump as strongly as a normal left ventricle," says Dr. Kaushal. "We are grateful to FDA, Lurie Children’s Hospital IRB, and Longeveron for making this happen, and we are hoping this therapy will be a game-changer for this baby and others in the future.”
“Our goal is to provide a new way to treat HLHS and we believe, based on previous studies, that the MSCs in Lomecel-B may improve ventricular and vascular function,” stated Geoff Green, CEO of Longeveron.
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