Study Identification Unique Protocol ID: B01-04 Brief Title: MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2) Official Title: MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2) Secondary IDs:

Study Status Record Verification: August 2019 February 2020 Overall Status: Recruiting Study Start: July 28, 2018 Primary Completion: December 2020 [Anticipated] Study Completion: September 2021 [Anticipated] First Submitted: May 23, 2018 First Submitted that

Met QC Criteria: May 23, 2018 First Posted: June 4, 2018 [Actual] Last Update Submitted that

Met QC Criteria: August 10, 2019 February 27, 2020 Last Update Posted: August 13, 2019 [Actual] February 28, 2020 [Actual]

Oversight U.S. FDA-regulated Drug: Yes U.S. FDA-regulated Device: No Data Monitoring: Yes

Study Description 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. Detailed Description:

Conditions Conditions: Ischemic Stroke Keywords: ischemic stroke

adult stem cells

Study Design Study Type: Interventional Primary Purpose: Treatment Study Phase: Phase 3 Interventional Study Model: Parallel Assignment Number of Arms: 2 Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Allocation: Randomized Enrollment: 300 [Anticipated]

Arms and Interventions Arms Assigned Interventions Experimental: MultiStem 1.2 billion cells Biological: MultiStem single intravenous infusion 18-36 hours after stroke Placebo Comparator: Placebo Biological: Placebo single intravenous infusion 18-36 hours after stroke

Outcome Measures Primary Outcome Measures: 1. 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: 2. 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]



[Time Frame: 365 days] 3. 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]



[Time Frame: 90 days] 4. 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

Eligibility Minimum Age: 18 Years Maximum Age: Sex: All Gender Based: Accepts Healthy Volunteers: No 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

IPDSharing Plan to Share IPD: Undecided