Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

NCT02833792 | Unknown Phase 2 DMC

• 1 other identifier: STEM105-M-AD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety of aMBMC administration

  Number of patients with adverse events will be reported

  18 months

Secondary Outcomes (1)

• Efficacy of aMBMC administration

  18 months

Study Arms (2)

Stem Cells

EXPERIMENTAL

Stem cells

Drug: Human Mesenchymal Stem Cells and Lactated Riunger's Solution

Placebo

PLACEBO COMPARATOR

Lactated Ringer's Solution

Other: Placebo

Interventions

Human Mesenchymal Stem Cells and Lactated Riunger's Solution DRUG

Intravenous administration

Stem Cells

Placebo OTHER

Intravenous administration

Placebo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stemedica Cell Technologies, Inc.: lead
• Stemedica International SA: collaborator

Study Sites (1)

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

Santa Monica, California, 90404, United States

RECRUITING

Related Links

• Sponsor information

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lev Verkh, PhD

  Stemedica Cell Technologies

  STUDY CHAIR

Central Study Contacts

Lev Verkh, PhD

CONTACT

858-658-0910; lverkh@stemedica.com

Marcie Frank, RN BSN

CONTACT

858-658-0910; mfrank@stemedica.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: July 14, 2016
• Study Start: June 1, 2016
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 28, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)