A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke
A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke
1 other identifier
interventional
38
1 country
3
Brief Summary
The purpose of this study is to assess the safety and tolerability of allogeneic adult mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2011
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2018
CompletedDecember 3, 2018
November 1, 2018
6.6 years
February 10, 2011
November 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period.
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations.
12 month
Secondary Outcomes (4)
National Institutes of Health Stroke Scale Score.
12 months
Mini Mental Status Exam score.
12 month
Barthel Index Score.
12 month
The Geriatric Depression Scale Score.
12 month
Study Arms (1)
Stem cells
EXPERIMENTALAll subjects will receive allogeneic adult mesenchymal bone marrow stem cells
Interventions
Patients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of ischemic stroke for longer than 6 months
- Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
- No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
- NIHSS score between 6-20
- Life expectancy greater than 12 months
- Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke
- Adequate organ function as defined by the following criteria:
You may not qualify if:
- History of uncontrolled seizure disorder
- History of cancer within the past 5 years.
- History of cerebral neoplasm
- Positive for hepatitis B, C or HIV
- Myocardial infarction withing six months of study entry
- Findings on baseline CT suggestive of subarachnoid or intracerebral hemorrhage within past 12 months.
- Allergies to Bovine or Porcine products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stemedica Cell Technologies, Inc.lead
- University of California, San Diegocollaborator
- Mercy Gilbert Medical Center at AZcollaborator
- Chandler Regional Medical Center at Chandler AZcollaborator
- UCI Medical Centercollaborator
Study Sites (3)
Mercy Gilbert and Chandler Medical Center
Gilbert, Arizona, 85224, United States
University of California Irvine Department of Neurology
Orange, California, 92868, United States
University of California San Diego Division of Neurological Surgery
San Diego, California, 92123, United States
Related Publications (1)
Levy ML, Crawford JR, Dib N, Verkh L, Tankovich N, Cramer SC. Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke. Stroke. 2019 Oct;50(10):2835-2841. doi: 10.1161/STROKEAHA.119.026318. Epub 2019 Sep 9.
PMID: 31495331DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lev Verkh, PhD
Stemedica Cell Technologies, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 16, 2011
Study Start
February 1, 2011
Primary Completion
September 1, 2017
Study Completion
November 15, 2018
Last Updated
December 3, 2018
Record last verified: 2018-11