RECRUITING

Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

Talk to us

Conditions

Alzheimer Dementia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-06-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02833792

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.

Ages Eligible for Study:55 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males or females between 55-80 years of age.
  2. 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. 3. Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) Alzheimer's criteria.
  4. 4. MMSE between 12-24 (inclusive) at time of enrollment.
  5. 5. Amyloid-positive florbetapir PET scan.
  1. 1. Prior treatment with stem cells.
  2. 2. History of intracranial, subdural, or subarachnoid hemorrhage.
  3. 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. 4. History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
  5. 5. History of seizure disorder.
  6. 6. Diagnosis of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL).
  7. 7. History of cerebral neoplasm.
  8. 8. Myocardial infarction within six months of enrollment.

Contacts and Locations

Study Contact

Lev Verkh, PhD
CONTACT
858-658-0910
lverkh@stemedica.com
Marcie Frank, RN BSN
CONTACT
858-658-0910
mfrank@stemedica.com

Principal Investigator

Lev Verkh, PhD
STUDY_CHAIR
Stemedica Cell Technologies

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Stemedica Cell Technologies, Inc.

  • Lev Verkh, PhD, STUDY_CHAIR, Stemedica Cell Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-06-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2016-06-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer Dementia