Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke

Study Overview
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Brief Summary
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Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.

Official Title
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Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Biological: bone marrow-derived mesenchymal stem cells
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated, radiologically confirmed, and with either diameter >15 mm or volume > 4cc. 2. The index stroke has clinical deficits that are moderate-severe (NIHSS score 7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring, and was not associated with a concomitant STelevation myocardial infarction. 3. Age 18-80 years, inclusive 4. Reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy. Exclusion Criteria: 1. No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2). 2. Females of child-bearing potential will be excluded unless (1) a negative urine pregnancy test is obtained and (2) the patient has been effectively using contraceptive method with known failure rate <1 % for at least 90 days. 3. Lactating mothers 4. If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion. 5. Known allergy to penicillin or to fetal bovine serum 6. Active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse. 7. Any diagnosis that makes survival to 1-year post-stroke unlikely. 8. Participation in any other experimental therapeutic clinical trial concurrently or in the prior three months. 9. Contraindication to undergoing MRI scanning.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mesenchymal stem cells<br>bone marrow-derived mesenchymal stem cells | Biological: bone marrow-derived mesenchymal stem cells<br>* bone marrow-derived mesenchymal stem cells<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 1 month after transfusion |