Open
Actively Recruiting
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
20-000881
Category
Neurology
Urology
Principal Investigator
Contact
Location
- UCLA Westwood