Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

Condition
Alzheimer Dementia
Intervention / Treatment

-

Contacts and Locations

Santa Monica

John Wayne Cancer Institute @ Providence St. John's Health Center, Santa Monica, California, United States, 90404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

55 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stemedica Cell Technologies, Inc.,

Lev Verkh, PhD, STUDY_CHAIR, Stemedica Cell Technologies

Study Record Dates

2024-12-31