Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

Alzheimer Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02833792
• Other study ID #: STEM105-M-AD
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2020
• Source: Stemedica Cell Technologies, Inc.
• Contact: Lev Verkh, PhD
• Phone: 858-658-0910
• Email: lverkh[@]stemedica.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Males or females between 55-80 years of age.

2. Diagnosed with mild to moderate dementia for at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative

3. Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) Alzheimer's criteria.

4. MMSE between 12-24 (inclusive) at time of enrollment.

5. Amyloid-positive florbetapir PET scan.

Exclusion Criteria:

1. Prior treatment with stem cells.

2. History of intracranial, subdural, or subarachnoid hemorrhage.

3. Subjects with baseline brain MRI showing more than four (4) cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), and/or one (1) or more areas of superficial siderosis, and/or evidence of a prior macrohemorrhage. MRI must include fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences.

4. History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.

5. History of seizure disorder.

6. Diagnosis of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL).

7. History of cerebral neoplasm.

8. Myocardial infarction within six months of enrollment.

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Dementia

Intervention

Drug:
• Human Mesenchymal Stem Cells and Lactated Riunger's Solution
Intravenous administration

Other:
• Placebo
Intravenous administration

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute @ Providence St. John's Health Center	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Stemedica Cell Technologies, Inc.	Stemedica International SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of aMBMC administration	Number of patients with adverse events will be reported	18 months
Secondary	Efficacy of aMBMC administration	Changes is scores relatively to baseline using NIHSS system will be reported for each patient	18 months

External Links

•   Sponsor information