First Longeveron Mesenchymal Stem Cell Treatment Administered to an Infant with Rare Heart Condition as Part of Groundbreaking Clinical Trial
February 27, 2018
Longeveron announced that its pioneering clinical trial to treat infants with Hypoplastic Left Heart Syndrome officially started with the first patient receiving the company’s mesenchymal stem cell therapy in a procedure performed at the University of Maryland Medical Center in Baltimore
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Feb. 27, 2018 14:57 ET
MIAMI, Feb. 27, 2018 /PRNewswire/ — Longeveron announced that its pioneering clinical trial to treat infants with Hypoplastic Left Heart Syndrome officially started with the first patient receiving the company’s mesenchymal stem cell therapy in a procedure performed at the University of Maryland Medical Center in Baltimore.
Hypoplastic Left Heart Syndrome (HLHS) is a rare and often fatal heart condition caused by an underdeveloped heart. One aim of the clinical trial is to determine if the stem cell treatment can improve the ventricular function of the heart in affected infants.
“The hope is the stem cell therapy available through this clinical trial will be a game-changer for these infants, an effective way to improve their outcomes and allow them to live longer lives,” said Dr. Sunjay Kaushal, Director of Pediatric Cardiac Surgery at the University of Maryland. Dr. Kaushal performed the procedure.
The Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome (ELPIS) is an open-label clinical trial enrolling 30 infants with HLHS. The study is a partnership between Longeveron, a Miami-based regenerative medicine company, the University of Maryland and Johns Hopkins University. The Maryland Stem Cell Research Fund (MSCRF) provided a $750,000 grant to support this groundbreaking stem cell research.
The grant was part of the MSCRF’s Accelerating Cure initiative. The Maryland Governor and the state’s General Assembly established the MSCRF through the Maryland Stem Cell Research Act of 2006 to accelerate research using human stem cells and advance medical treatment.
Longeveron is researching treatments based on its Mesenchymal Stem Cells for a variety of aging-related diseases. In 2017, Longeveron published positive Phase I and Phase 2 clinical studies in the Journals of Gerontology that evaluated the safety and efficacy of its Mesenchymal Stem Cells in patients with Aging Frailty, a serious geriatric syndrome that can lead to other severe health conditions, such as heart disease. The company is now recruiting for an expanded Phase 2b Aging Frailty study.
Longeveron is also recruiting for a Phase 1 Alzheimer’s trial, and Phase 1 and 2 trials to evaluate the safety and efficacy of its stem cells for improving flu vaccine immune response in Aging Frailty patients. Longeveron’s MSC product is derived from the bone marrow of young, healthy adult donors.
Longeveron’s MSCs are also approved for use in the Bahamas. As the only company to have a locally-approved allogeneic stem cell treatment, Longeveron currently is conducting a single-arm open label clinical trial for Aging Frailty in the Bahamas and is planning to add other indications to its Bahamas trial including cognitive disorders and orthopedic conditions.
Longeveron (www.longeveron.com) is a regenerative medicine therapy company founded in 2014. Longeveron’s goal is to provide the first of its kind biological solution for aging-related diseases, and is dedicated to developing safe cell-based therapeutics to revolutionize the aging process and improve quality of life. The company’s research focus areas Aging Frailty, the Metabolic Syndrome and Alzheimer’s Disease and gratefully acknowledges the generous support of the National Institutes of Health, the Alzheimer’s Association and Maryland Stem Cell Research Fund. Longeveron is also conducting a Phase 1 trial to study Hypoplastic Left Heart Syndrome, a rare indication that affects infants, supported through a grant from the Maryland Stem Cell Research Fund.
For more information about the clinical trials
Longeveron is sponsoring, visit ClinicalTrials.gov
SOURCE Longeveron LLC