Clinical Trials

One in 85 persons worldwide will be living with Alzheimer’s disease (AD), according to forecasts by Johns Hopkins University. To date, there is no cure for AD. Current FDA-approved therapies are symptomatic treatments that only modestly improve cognitive functions and do not stop the progression of the disease.

Stemedica International’s unique, disease-modifying treatment combines itMSCs, itNSCs and related stem cell factors to improve the quality of life for AD patients. The company has conducted extensive pre-clinical studies to assess the technology’s safety and efficacy on amyloid pathology and brain function in preparation for clinical applications in patients with mild to moderate AD. The data strongly supports that Stemedica International’s therapy safely removes cerebral amyloid plaques, bringing new hope to patients and families affected by the condition. Pre-clinical data also supports the therapy’s potential application for patients with mild cognitive impairment (MCI).

Stemedica Cell Technologies, Inc. and Stemedica International S.A. are conducting the first clinical trial in the United States using adult allogeneic stem cells to treat Alzheimer’s disease. Enrollment is open at Emory University in Atlanta and University of California, Irvine (UCI). The study is entitled, “A Phase IIa Multicenter, Randomized, Single-blind, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer’s Disease.”

The study will enroll approximately 40 subjects diagnosed with mild to moderate dementia due to Alzheimer’s disease (AD) 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 (NINCDS-ADRDA) Alzheimer’s criteria.

More information about this clinical trial, including enrollment details, can be found at:

https://clinicaltrials.gov/ct2/show/NCT02833792?term=stemedica&rank=1. or see below.

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.


Condition Intervention Phase
Alzheimer Dementia Drug: Human Mesenchymal Stem Cells and Lactated Ringer’s Solution
Other: Placebo		 Phase 2

 
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase IIa Study of Allogeneic Human Mesenchymal Stem Cells in Subjects With Mild to Moderate Dementia Due to Alzheimer’s Disease

Resource links provided by NLM:

 

U.S. FDA Resources

Further study details as provided by Stemedica Cell Technologies, Inc.:

 

Primary Outcome Measures:
  • Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Safety assessments measured by adverse events

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Efficacy assessments measures by neurological examinations
Estimated Enrollment: 40
Study Start Date: June 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem Cells
Stem cells
 Drug: Human Mesenchymal Stem Cells and Lactated Riunger’s Solution
Intravenous administration
Placebo Comparator: Placebo
Lactated Ringer’s Solution
 Other: Placebo
Intravenous administration

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.

  Eligibility
Ages Eligible for Study: 55 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02833792

Contacts
Contact: Becky Byram, M.Ed. 404-712-0195 rbyram@emory.edu
Contact: Durk Thompson 949-824-1114 durkt@uci.edu

Locations
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30329
Contact: Becky Byram, M.Ed.    404-712-0195    rbyram@emory.edu
Sponsors and Collaborators
Stemedica Cell Technologies, Inc.
Stemedica International SA
Investigators
Study Director: Lev Verkh, PhD Stemedica Cell Technologies

  More Information

Additional Information:
Sponsor information  This link exits the ClinicalTrials.gov site
Responsible Party: Stemedica Cell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02833792     History of Changes
Other Study ID Numbers: STEM105-M-AD
Study First Received: June 20, 2016
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data
Plan to Share IPD: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases		 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders