Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title: A Phase, I Prospective, Randomized, Double-Blinded, Placebo-controlled, Trial to Evaluate the Safety and Potential Efficacy of Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease

Status Completed

Clinical Trial Summary

This is a Phase I, prospective, randomized, placebo-controlled, double-blinded study designed to test the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) for the treatment of subjects with clinically diagnosed Alzheimer's disease.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

• NCT number: NCT02600130
• Study type: Interventional
• Source: Longeveron Inc.
• Status: Completed
• Phase: Phase 1
• Start date: October 10, 2016
• Completion date: September 2021