Longeveron, a Florida-based biotech and regenerative medicine company, is moving forward with a clinical trial studying the safety and efficacy of stem cell treatments for aging-related diseases.
Who is Longeveron?
A life sciences company developing biological solutions for aging and aging-associated diseases through the use of Allogeneic Human Mesenchymal Stem Cells, harvested and grown at their facility in Miami, Florida from adult-donor bone marrow. The Longeveron-grown Mesenchymal Stem Cells (LMSCs) are multipotent stem cells. Founded in 2014, they have raised approximately $7 million.
Longeveron Clinical Trials
They are currently conducting clinical trials. We include a couple examples of Longeveron stem cell trials listed in Clinicaltrials.gov.
Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty. The objectives of this Phase 2b study are to assess safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) compared to placebo on 1) functional mobility and exercise tolerance, 2) patient-reported physical function, and 3) the inflammatory cytokine biomarker tumor necrosis factor (TNF-a).
Target Participants: 150
Planned Completion: September, 2020
Allogeneic Human Mesenchymal Stem Cell Infusion Versus Placebo in Patients with Alzheimer’s Disease.
This is a randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) or placebo in subjects with Alzheimer’s Disease. Following a successful Safety Run-In Phase, a total of twenty-five (25) subjects will be randomized to (2:2:1) to receive low-dose LMSCs, high-dose LMSCs or placebo. After randomization, baseline imaging, and study product infusion, subjects will be followed up at 2,4,13, 26, 39- and 52-week post study product infusion. Intention-to-treat study population will be used for the purpose of the endpoint analysis and safety evaluations.
Total Participants: 30
Planned Completion: March, 2020