Phase II Study reveals the efficacy of Mesenchymal Stem Cells treating age-related disabilities.

Building on Phase I and Phase II studies, Miami-based Longeveron LLC announced it is progressing with the development of a therapeutic stem cell treatment based on transplanting allogenic Mesenchymal Stem Cells (MSCs) to treat aging frailty. Conducted by the University Of Miami Miller School Of Medicine, the tolerability and efficacy results of the studies were published October 12 in the Oxford University Press Journals of Gerontology.

According to Longeveron, based on reviews of the submitted papers, the editors of Journals of Gerontology offered an editorial affirming that "MSC transplantation is a promising and innovative approach for the treatment of frailty in older humans" and "stem cells might be the vehicles for youthful regeneration of aged tissues."

Longeveron notes that for aging populations stem cells hold great promise to treat age-related disabilities and frailty, the goal being to improve people’s physical capacity and quality of life. “There is no FDA approved treatment for aging frailty and an enormous unmet need that will only increase with the changing demographics,” said Joshua M. Hare, Longeveron Chief Science Officer and Co-Founder and Director of the Interdisciplinary Stem Cell Institute at the University of Miami, Miller School of Medicine.

Longeveron said it derives allogeneic human MSCs from human adult donor bone marrow. The company said its Phase II study of MSCs consisted of a randomized, double-blinded trial involving 30 frail patients with an average age of 76. According to Longeveron, patients were administered two doses of 100 million or 200 million cells versus placebo. “Participants showed marked improvement in physical performance, lung function and inflammation biomarkers, all major aspects of frailty, with no serious adverse events attributable to the product,” said the company.

Hare explained Longeveron is following a very careful, very rigorous testing process in its efforts to get the FDA’s approval of its stem cell therapies. Lead author of the Phase I trial, University of Miami Miller School of Medicine/Jackson Memorial Hospital’s Dr. Samuel Golpanian said, "This pioneering Phase II study has shown that MSC treatment is safe in this patient population and produces remarkable improvement in function and immunologic levels, confirming the outcomes shown in the company's Phase I clinical trial. The positive results demonstrated by the research are also extremely significant in that they clearly point to the need for continued clinical development of cell-based therapy for aging frailty."