Longeveron has announced that their Phase 1 Alzheimer’s disease trial will proceed with enrolment 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, 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 (Miami, USA) states, “The first five patients in our program have so far shown that the use of LMSCs in Alzheimer’s disease is safe.” Baumel continues, “We are now going to continue to enrol 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 US 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.