Study to Examine the Effects of MultiStem in Ischemic Stroke

Study Overview
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Brief Summary
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A study to examine the safety and potential effectiveness of the adult stem cell investigational product, MultiStem, in adults who have suffered an ischemic stroke. The hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.

Official Title
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Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Biological: MultiStem
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects between 18 and 83 years of age (inclusive) Clinical diagnosis of cortical cerebral ischemic stroke Occurrence of a moderate to moderately severe stroke Exclusion Criteria: Presence of a lacunar or a brainstem infarct Reduced level of consciousness Major neurological event such as stroke or clinically significant head trauma within 6 months of study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 83 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 |
| --- | --- |
| Experimental: Cohort 1<br>Low dose MultiStem or Placebo | Biological: MultiStem<br>* single infusion 1-2 days following ischemic stroke<br>Biological: Placebo<br>* single infusion 1-2 days following ischemic stroke<br>|
| Experimental: Cohort 2<br>High dose MultiStem or Placebo | Biological: MultiStem<br>* single infusion 1-2 days following ischemic stroke<br>Biological: Placebo<br>* single infusion 1-2 days following ischemic stroke<br>|
| Experimental: Cohort 3<br>Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo | Biological: MultiStem<br>* single infusion 1-2 days following ischemic stroke<br>Biological: Placebo<br>* single infusion 1-2 days following ischemic stroke<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of dose limiting adverse events |  | 7 days | 
| Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI) |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects with a mRS score of less than or equal to 2 |  | 90 days | 
| change in functional outcome throughout range of mRS scores |  | 90 days | 
| changes in outcome measures (mRS, NIHSS, BI) over time |  | 365 days | 
| proportion of subjects with an excellent functional outcome | mRS score = 0 to 1; and NIHSS score = 0 to 1; and Barthel Index score = greater than or equal to 95 | 90 days | 
| frequency of adverse events |  | 365 days | 
| change in vital signs |  | 365 days | 
| change in safety labs |  | 365 days | 
| frequency of secondary infections |  | 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, adult stem cells