MIAMI, Dec. 20, 2019 — Longeveron LLC, a leading developer of adult stem cell technologies for chronic, aging-related and life-threatening conditions, announced today that it has completed enrollment in its Phase 1 Alzheimer’s disease trial. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of LMSCs in patients with mild Alzheimer’s disease (AD).
“This announcement marks a significant milestone for our company, the AD community, and our many supporters and stakeholders,” said Geoff Green, President of Longeveron. “We would particularly like to thank the Alzheimer’s Association for their continued support through the Part the Cloud Challenge on Neuroinflammation funding, which has enabled Longeveron to conduct this important clinical study.”
Alzheimer’s disease, the most common form of dementia, is a progressive disease in which symptoms gradually worsen over several years and ultimately lead to death. It is currently the sixth leading cause of death in the United States. There are no known cures for AD, and no approved therapies that can prevent, slow-down, or reverse the progression of the disease.
“The pathophysiology of Alzheimer’s disease is complex, and includes not only the hallmarks of beta-amyloid deposits and neurofibrillary tangles, but neuroinflammation, vascular dysfunction, and of course, neurodegeneration,” said Dr. Anthony Oliva, Senior Scientist at Longeveron and Principal Investigator of the grant. “LMSCs have multiple mechanisms of action that make them highly attractive candidates for treating neurodegenerative disorders such as AD. Previous animal and human studies have shown this cell type has powerful anti-inflammatory and pro-regenerative properties, and can treat amyloidosis, among many other highly desired properties that would be exactly what one would want for treating AD.”
It is anticipated that the final trial results will become available in late 2020. Thirty-three subjects were enrolled from 4 clinical trial sites and randomized to receive a single peripheral intravenous infusion of either LMSCs, or placebo. The primary objective of the study is to assess safety and tolerability of LMSC infusion, and to explore efficacy using a variety of neurocognitive assessment tools, Quality of Life assessment, and biomarker analyses that include Magnetic Resonance Imaging (MRI) of the brain.
Longeveron Allogeneic Mesenchymal Stem Cells (LMSCs) is a regenerative medicine product sourced from the bone marrow of young healthy adult donors. LMSCs are culture expanded under current good manufacturing practices (cGMP) to high purity, and maintained as individual “off-the-shelf” doses.
About Longeveron LLC
Longeveron (www.longeveron.com) is a regenerative medicine therapy company founded in 2014. Longeveron’s mission is to provide biological solutions for aging-related diseases and life-threatening conditions, and is dedicated to developing safe and effective cell-based therapeutics for unmet medical needs such as Aging Frailty, the Metabolic Syndrome, Alzheimer’s Disease and congenital heart defects in children (hypoplastic left heart syndrome).
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