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:
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.
To assess the preliminary efficacy of hMSCs versus placebo in subjects with Alzheimer’s-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.
|Alzheimer Dementia||Drug: Human Mesenchymal Stem Cells and Lactated Ringer’s Solution
|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|
- Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Safety assessments measured by adverse events
- Efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Efficacy assessments measures by neurological examinations
|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)|
|Experimental: Stem Cells
|Drug: Human Mesenchymal Stem Cells and Lactated Riunger’s Solution
|Placebo Comparator: Placebo
Lactated Ringer’s Solution
Please refer to this study by its ClinicalTrials.gov identifier: NCT02833792
|Contact: Becky Byram, M.Ed.||firstname.lastname@example.org|
|Contact: Durk Thompsonemail@example.com|
|United States, Georgia|
|Emory University School of Medicine||Recruiting|
|Atlanta, Georgia, United States, 30329|
|Contact: Becky Byram, M.Ed. 404-712-0195 firstname.lastname@example.org|
|Study Director:||Lev Verkh, PhD||Stemedica Cell Technologies|