Clinical Trials
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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 |
- 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
| 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:
Eligibility| Ages Eligible for Study: | 55 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02833792
| Contact: Becky Byram, M.Ed. | 404-712-0195 | rbyram@emory.edu | |
| Contact: Durk Thompson | 949-824-1114 | durkt@uci.edu |
| 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 | |
| Study Director: | Lev Verkh, PhD | Stemedica Cell Technologies |
More Information
Additional Information:
| 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 |