MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

Study Overview
=================
Brief Summary
-----------------
A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.

Official Title
-----------------
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Biological: MultiStem
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Male or female subjects ≥18 years of age Clinical diagnosis of ischemic stroke involving cerebral cortex Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke Primary Exclusion Criteria: Presence of a lacunar or a brainstem infarct Comatose state Brain hemorrhage Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MultiStem<br>1.2 billion cells | Biological: MultiStem<br>* single intravenous infusion 18-36 hours after stroke<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* single intravenous infusion 18-36 hours after stroke<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: | mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100] | 365 days | 
| proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: | mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100] | 90 days | 
| proportion of subjects with a mRS score of less than or equal to 2 [scale range 0 to 6] demonstrating the ability to function independently |  | 90 days | 

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