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Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

Primary Purpose

Alzheimer Dementia

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Human Mesenchymal Stem Cells and Lactated Riunger's Solution

Placebo

About this trial

This is an interventional treatment trial for Alzheimer Dementia

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or females between 55-80 years of age.
Diagnosed with mild to moderate dementia for at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative
Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) Alzheimer's criteria.
MMSE between 12-24 (inclusive) at time of enrollment.
Amyloid-positive florbetapir PET scan.

Exclusion Criteria:

Prior treatment with stem cells.
History of intracranial, subdural, or subarachnoid hemorrhage.
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.
History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
History of seizure disorder.
Diagnosis of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL).
History of cerebral neoplasm.
Myocardial infarction within six months of enrollment.

Sites / Locations

John Wayne Cancer Institute @ Providence St. John's Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stem Cells

Placebo

Arm Description

Stem cells

Lactated Ringer's Solution

Outcomes

Primary Outcome Measures

Safety of aMBMC administration

Number of patients with adverse events will be reported

Secondary Outcome Measures

Efficacy of aMBMC administration

Changes is scores relatively to baseline using NIHSS system will be reported for each patient

Full Information

NCT ID

NCT02833792

First Posted

June 20, 2016

Last Updated

October 27, 2022

Sponsor

Stemedica Cell Technologies, Inc.

Collaborators

Stemedica International SA

1. Study Identification

Unique Protocol Identification Number

NCT02833792

Brief Title

Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2016 (Actual)

Primary Completion Date

July 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stemedica Cell Technologies, Inc.

Collaborators

Stemedica International SA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Dementia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stem Cells

Arm Type

Experimental

Arm Description

Stem cells

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Lactated Ringer's Solution

Intervention Type

Drug

Intervention Name(s)

Human Mesenchymal Stem Cells and Lactated Riunger's Solution

Intervention Description

Intravenous administration

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Intravenous administration

Primary Outcome Measure Information:

Title

Safety of aMBMC administration

Description

Number of patients with adverse events will be reported

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Efficacy of aMBMC administration

Description

Changes is scores relatively to baseline using NIHSS system will be reported for each patient

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females between 55-80 years of age. Diagnosed with mild to moderate dementia for at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) Alzheimer's criteria. MMSE between 12-24 (inclusive) at time of enrollment. Amyloid-positive florbetapir PET scan. Exclusion Criteria: Prior treatment with stem cells. History of intracranial, subdural, or subarachnoid hemorrhage. 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. History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma. History of seizure disorder. Diagnosis of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL). History of cerebral neoplasm. Myocardial infarction within six months of enrollment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lev Verkh, PhD

Phone

858-658-0910

lverkh@stemedica.com

First Name & Middle Initial & Last Name or Official Title & Degree

Marcie Frank, RN BSN

Phone

858-658-0910

mfrank@stemedica.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lev Verkh, PhD

Organizational Affiliation

Stemedica Cell Technologies

Official's Role

Study Chair

Facility Information:

Facility Name

John Wayne Cancer Institute @ Providence St. John's Health Center

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mini Gill, RN BSN

Phone

310-582-7437

Jaya.Gill@providence.org

First Name & Middle Initial & Last Name & Degree

Santosh Kesari, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://stemedica.com

Description

Sponsor information

Learn more about this trial

Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

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