NCT02833792

Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

A Phase IIa Study of Allogeneic Human Mesenchymal Stem Cells in Subjects With Mild to Moderate Dementia Due to Alzheimer's Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Stemedica Cell Technologies, Inc. · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

STUDY OBJECTIVES Primary: To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to subjects with mild to moderate dementia due to Alzheimer's disease. Secondary: To assess the preliminary efficacy of hMSCs versus placebo in subjects with Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.

Detailed description

This is a Phase IIa multi-center, randomized, single-blind, placebo-controlled, crossover study in subjects with mild to moderate dementia due to Alzheimer's disease. Only the subject and their caregiver will be blinded to the study treatment. The study will consist of two cohorts of subjects (20 subjects per cohort), randomized in a 1:1 allocation to receive active study drug or placebo. Cohort 1 will receive a single intravenous dose of hMSCs of 1.5 million cells per kilogram body weight on their Study Day 1, and Cohort 2 will receive equal volume of Lactated Ringer's Solution on their Study Day 1. At the six-month time point for each subject after their first infusion, Cohort 1 will receive a single intravenous dose of Lactated Ringer's Solution and Cohort 2 will receive a single intravenous dose of hMSCs at 1.5 million cells per kilogram of the subject's body weight. Approximately 40 subjects will be enrolled in this study. An independent Data and Safety Monitoring Board will conduct periodic safety reviews.

Conditions

• Alzheimer Dementia

Interventions

Type	Name	Description
DRUG	Human Mesenchymal Stem Cells and Lactated Riunger's Solution	Intravenous administration
OTHER	Placebo	Intravenous administration

Timeline

• Start date: 2016-06-01
• Primary completion: 2024-07-30
• Completion: 2024-12-31
• First posted: 2016-07-14
• Last updated: 2022-10-28

Locations

1 site across 1 country: United States