Longeveron LLC, a biopharmaceutical company that develops stem cell therapies for age-related diseases, announced that it is currently recruiting for a Phase 1 clinical trial to evaluate the safety and efficacy of its allogeneic Mesenchymal Stem Cells (MSCs) in patients with Alzheimer’s disease. The randomized, placebo-controlled, double-blinded trial is seeking up to 30 participants and is being conducted at the University of Miami Miller School of Medicine, Miami Jewish Health Systems, and Brain Matters Research in Delray Beach, Florida.
Eligible participants should be between 50 and 80 years old, be diagnosed with Alzheimer’s in accordance with established criteria, and have an identified adult caregiver. Longeveron’s research is supported by the Alzheimer’s Association Part the Cloud Challenge on Neuroinflammation.
Longeveron’s MSC product is derived from the bone marrow of young, healthy donors and is currently being tested in a variety of indications in clinical trials, including Aging Frailty. In 2017, the company published positive Phase I and Phase 2 Aging Frailty study results in the Journals of Gerontology. Frail patients showed marked improvement in physical performance, lung function and inflammation biomarkers, with no serious adverse effects attributed to the treatment.
“Regenerative medicine is the future. Controlling inflammation in Alzheimer’s disease is the key to a breakthrough,” noted Mark Brody, M.D. of Brain Matters Research in Delray Beach, Florida, a site for the clinical trial.
Marc Agronin, M.D., geriatric psychiatrist and vice president of Behavioral Health and Clinical Research at Miami Jewish Health, said, “Alzheimer’s disease is one of the most pressing health care issues for aging individuals, and we need an effective treatment, if not a cure. An innovative study such as the Longeveron stem cell clinical trial is an important and promising step forward.”
In addition to the Alzheimer’s trial, Longeveron is recruiting nationally for an expanded Phase 2b Aging Frailty study, as well as Phase 1 and Phase 2 trials to evaluate the safety and efficacy of its stem cells for improving flu vaccine immune response in aging frailty patients. For more information about the Alzheimer’s trial and other trials Longeveron is sponsoring, visit ClinicalTrials.gov or Longeveron’s Web site www.longeveron.com