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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Dementia
• Intervention / Treatment: Drug: Human Mesenchymal Stem Cells and Lactated Riunger's Solution; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lev Verkh, PhD; Phone Number: 858-658-0910; Email: lverkh@stemedica.com
• Study Contact Backup: Name: Marcie Frank, RN BSN; Phone Number: 858-658-0910; Email: mfrank@stemedica.com

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Recruiting
      • John Wayne Cancer Institute @ Providence St. John's Health Center
      • Contact: Mini Gill, RN BSN; Phone Number: 310-582-7437; Email: Jaya.Gill@providence.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stem Cells; Stem cells	Drug: Human Mesenchymal Stem Cells and Lactated Riunger's Solution; Intravenous administration
PLACEBO_COMPARATOR: Placebo; Lactated Ringer's Solution	Other: Placebo; Intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of aMBMC administration	Number of patients with adverse events will be reported	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of aMBMC administration	Changes is scores relatively to baseline using NIHSS system will be reported for each patient	18 months

Collaborators and Investigators

• Sponsor: Stemedica Cell Technologies, Inc.
• Collaborators: Stemedica International SA
• Investigators: Study Chair: Lev Verkh, PhD, Stemedica Cell Technologies

Publications and helpful links

Helpful Links

• Sponsor information

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ANTICIPATED): July 30, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (ESTIMATE): July 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: STEM105-M-AD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO