Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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)

Keywords

Ischemic Stroke adult stem cells Stroke MultiStem

Eligibility

For people ages 18 years and up

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

Locations

  • Athersys Investigational Site 127 accepting new patients
    Sacramento California 95817 United States
  • Athersys Investigational Site 122 accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Athersys, Inc
Links
Sign up for this study
ID
NCT03545607
Phase
Phase 3
Study Type
Interventional
Last Updated