Recruiting
Phase 2

Allogeneic Stem Cells

Sponsor:

Stemedica Cell Technologies, Inc.

Code:

NCT02833792

Conditions

Alzheimer Dementia

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Human Mesenchymal Stem Cells and Lactated Riunger's Solution

Placebo

Study Details

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.

Conditions

Alzheimer Dementia

Study ID

NCT02833792

Start date

Jun 1, 2016

Status verified date

Oct, 2020

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jul 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stem Cells

Stem cells

placebo comparator: Placebo

Lactated Ringer's Solution

Interventions

Human Mesenchymal Stem Cells and Lactated Riunger's Solution

Intravenous administration

Placebo

Intravenous administration

Primary outcome measure

  • Safety of aMBMC administration [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Santa Monica, California, United States, 90404

Contacts

Principal Investigator:

Santosh Kesari, MD, PhD

More Information

Sponsor

Stemedica Cell Technologies, Inc.

Last update posted

Oct 28, 2022

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stemedica Cell Technologies, Inc. on 2022-10-28.