Alzheimer Dementia
Conditions
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.
Interventions
DRUGHuman Mesenchymal Stem Cells and Lactated Riunger's Solution
Intravenous administration
OTHERPlacebo
Intravenous administration
Sponsors
Stemedica International SA
Stemedica Cell Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of aMBMC administration | 18 months | Number of patients with adverse events will be reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of aMBMC administration | 18 months | Changes is scores relatively to baseline using NIHSS system will be reported for each patient |
Countries
United States
Contacts
Primary ContactLev Verkh, PhD
Backup ContactMarcie Frank, RN BSN
Outcome results
None listed