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Phase 1 enrollment completed in groundbreaking stem cell trial for Alzheimer's disease



Longeveron, a stem cell research company focused on biological solutions for age-associated diseases, has announced the 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 in early March.  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 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 MSCs derived from the bone marrow of healthy adult donors for treating Alzheimer's disease.  

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