MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

Last updated: February 8, 2022
Sponsor: Athersys, Inc
Overall Status: Active - Recruiting

Phase

3

Condition

Thrombosis

Cerebral Ischemia

Cardiac Ischemia

Treatment

N/A

Clinical Study ID

NCT03545607
B01-04
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 neurologicdeficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4points during the initial screening period
  • A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke

Exclusion

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 6months of enrollment into the study

Study Design

Total Participants: 300
Study Start date:
July 28, 2018
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • Athersys Investigational Site 603

    Taichung, 40402
    Taiwan

    Active - Recruiting

  • Athersys Investigational Site 601

    Taipei City, 10002
    Taiwan

    Active - Recruiting

  • Athersys Investigational Site 602

    Taoyuan City, 33305
    Taiwan

    Active - Recruiting

  • Athersys Investigational Site 128

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Athersys Investigational Site 122

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Athersys Investigational Site 127

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Athersys Investigational Site 129

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Athersys Investigational Site 108

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Athersys Investigational Site 103

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Athersys Investigational Site 121

    Chicago, Illinois 60201
    United States

    Active - Recruiting

  • Athersys Investigational Site 119

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Athersys Investigational Site 124

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Athersys Investigational Site 113

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Athersys Investigational Site 125

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Athersys Investigational Site 111

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • Athersys Investigational Site 109

    Akron, Ohio 44304
    United States

    Active - Recruiting

  • Athersys Investigational Site 104

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Athersys Investigational Site 130

    Toledo, Ohio 43606
    United States

    Active - Recruiting

  • Athersys Investigational Site 102

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Athersys Investigational Site 107

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Athersys Investigational Site 106

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Athersys Investigational Site 118

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • Athersys Investigational Site 115

    Chattanooga, Tennessee 37403
    United States

    Active - Recruiting

  • Athersys Investigational Site 101

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Athersys Investigational Site 105

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Athersys Investigational Site 110

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

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