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Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

NCT02833792 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-10-28

No results posted yet for this study

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.

Conditions

  • Alzheimer Dementia

Interventions

DRUG

Human Mesenchymal Stem Cells and Lactated Riunger's Solution

Intravenous administration

OTHER

Placebo

Intravenous administration

Sponsors & Collaborators

  • Stemedica International SA

    collaborator UNKNOWN

  • Stemedica Cell Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Lev Verkh, PhD · Stemedica Cell Technologies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2024-07-30
Completion
2024-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02833792 on ClinicalTrials.gov