NCT02600130

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Longeveron Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Longeveron Mesenchymal Stem Cells	via peripheral intravenous infusion
BIOLOGICAL	Placebo	via peripheral intravenous infusion

Timeline

• Start date: 2016-10-10
• Primary completion: 2020-09-01
• Completion: 2021-09-01
• First posted: 2015-11-09
• Last updated: 2021-12-14

Locations

3 sites across 1 country: United States