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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
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
20-000881
Category
Neurology
Contact
David Liebeskind
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03545607
For detailed technical eligibility, visit ClinicalTrials.gov.