MIAMI, March 15, 2017 /PRNewswire/ -- Longeveron, a leading stem cell research company focused on biological solutions for age-associated diseases, announced today the successful completion of enrollment in the first phase of its clinical research trial of Longeveron allogeneic human mesenchymal stem cells (LMSCs®) to treat Alzheimer's disease.
The fifth and final patient needed for the initial safety "run-in" phase was infused last week. The Company will review the safety data prior to proceeding with the second phase: a 25-subject randomized, placebo-controlled, double-blind study evaluating the safety, tolerability and efficacy of LMSCs in early-stage Alzheimer's disease. The trial is taking place at the University of Miami's Miller School of Medicine.
"The impact of Alzheimer's disease is vast, far exceeding the medical community's current ability to treat it," said Joshua M. Hare, M.D., Longeveron's Co-Founder and Chief Science Officer. "Regenerative medicine and cell-based therapies offer a promising new approach to close this gap and address the urgent need for effective therapies to combat the condition."
An important component in the progression of Alzheimer's disease is neuroinflammation. Longeveron was recently awarded a $1 million Part the Cloud Challenge on Neuroinflammation grant from the Alzheimer's Association to help support this research.
"Adult stem cells are very potent anti-inflammatories. The characteristic amyloid plaques found in the brains of Alzheimer's disease patients produce inflammation, and stem cells can reduce inflammation," explained Bernard S. Baumel, M.D., Principal Investigator for the trial. "Alzheimer's also impairs the brain's ability to adequately produce new brain cells in the memory area known as the hippocampus. Stem cells can stimulate the brain to produce these new cells needed to form memory. We believe that an infusion of LMSCs may improve the condition or at least halt the progression of the disease."
Prior research shows that adult MSCs target and reduce inflammation, promote tissue repair and improve brain function in mouse models of Alzheimer's disease. Longeveron's trial is the first U.S. clinical study of exogenously administered mesenchymal stem cells derived from the bone marrow of healthy adult donors for treating Alzheimer's disease.
To learn about participating in the clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT02600130
Longeveron 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 include Alzheimer's disease, Aging Frailty and the Metabolic Syndrome. Longeveron produces LMSCs in its own state-of-the-art cGMP cell processing facility. www.longeveron.com
Suzanne Liv Page