Longeveron Begins Enrollment of Second Cohort of Phase 1 Trial of Allogeneic Mesenchymal Stem Cells to Treat Alzheimer’s Disease Patients
May 10, 2017
Longeveron, a regenerative medicine company, today announced that their Phase 1 Alzheimer’s disease trial will proceed with enrollment at the recommendation of an independent Data Monitoring Committee (DMC) which reviewed data from the trial’s safety run-in phase
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May 10, 2017
Data Monitoring Committee Confirms Safety and Recommends Trial Proceed
MIAMI, Fl., May 10, 2017 – Longeveron, a regenerative medicine company, today announced that their Phase 1 Alzheimer’s disease trial will proceed with enrollment at the recommendation of an independent Data Monitoring Committee (DMC) which reviewed data from the trial’s safety run-in phase.
The clinical trial is designed to assess the safety, tolerability and efficacy of intravenous infusion of two different doses of Longeveron mesenchymal stem cells (LMSCs) compared to placebo. The DMC reviewed safety data from a five-patient run-in phase where subjects diagnosed with Alzheimer’s disease were given a single infusion of either LMSCs or placebo. Longeveron now has the green light to continue the trial.
Barry Baumel, M.D. Principal Investigator and Director of the Memory Disorders Clinical Trials Group of the Department of Neurology at the University of Miami’s Miller School of Medicine stated, “The first five patients in our program have so far shown that the use of LMSCs in Alzheimer’s disease is safe.” Baumel continued, “We’re now going to continue to enroll and treat patients to see if stem cell treatment is effective in changing the typical worsening course of Alzheimer’s disease.”
The DMC is an independent group of experts that regularly reviews data from ongoing clinical trials and reports their findings to the trial sponsor regarding continued safety of trial subjects and potential subjects as well as the validity and scientific merit of the trial.
This trial is the first U.S. clinical study for treating Alzheimer’s disease with the use of exogenously administered mesenchymal stem cells derived from the bone marrow of healthy adult donors. Longeveron acknowledges the generous support of the Alzheimer’s Association through its Part of the Cloud Challenge on Neuroinflammation Grant.
To learn about participating in the clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT02600130
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 () 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