Longeveron Announces Publication of Phase 1 Safety and Efficacy Trial Results for Allogeneic Stem Cell Treatment in Frailty Patients
May 15, 2017
Longeveron LLC, a leading regenerative medicine company developing innovative therapies for age-related diseases, announced the publication of Phase 1 safety, tolerability and efficacy data of its proprietary allogeneic mesenchymal stem cell (MSC) product in patients with Aging Frailty. The results were published on April 21st online in the Journals of Gerontology
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May 15, 2017
MIAMI, Fl., May 15, 2017 – Longeveron LLC, a leading regenerative medicine company developing innovative therapies for age-related diseases, announced the publication of Phase 1 safety, tolerability and efficacy data of its proprietary allogeneic mesenchymal stem cell (MSC) product in patients with Aging Frailty. The results were published on April 21st online in the Journals of Gerontology.
According to the senior author, Samuel Golpanian, M.D., of the Department of Surgery at the University of Miami’s Miller School of Medicine/Jackson Memorial Hospital, “This study is ground-breaking, not only by demonstrating that MSC treatment in this patient population is safe, but the treatment has led to improvements in functional and immunologic status.“ Golpanian added, “These findings are critically important, since they suggest that ongoing clinical development of cell-based therapy is warranted for Aging Frailty.” These findings are reported in the Journals of Gerontology ahead of print at https://doi.org/10.1093/gerona/glx056
Aging Frailty is a common geriatric syndrome characterized by impaired strength, mobility and endurance, and increased weight loss and fatigue, leading to overall decline, loss of independence and mortality. This serious and life threatening condition currently has no FDA-approved therapy, and Longeveron is leading the effort to develop a safe and effective treatment for this unmet medical need.
Longeveron, building on its Phase 1 and Phase 2 trial results, will initiate a multicenter, randomized Phase 2b clinical trial of three different doses of its proprietary allogeneic MSCs compared to placebo in Aging Frailty subjects this month. Longeveron has exclusively licensed data from the Phase 1 and Phase 2 trials completed at the University of Miami’s Miller School of Medicine.
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 (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