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  • MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

Principal Investigator

Erika Marulanda-Londono

Enrollment Status

Closed

Clinical Trial ID

Institutional Protocol # 20180916
National Clinical Trials Identifier NCT03545607

Clinical Trial 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.


Phase

Phase 3


Funding Agency/Sponsor

Industry


Disease

Other


Enrollment Eligibility

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


Contact Information

Study Contact Paramjot Kaur
Phone Number +1 (754) 3041996
Email pxk325@miami.edu
Get detailed information on ClinicalTrials.Gov

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