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Study to Examine the Effects of MultiStem in Ischemic Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01436487
First Posted: September 19, 2011
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Athersys, Inc
  Purpose
A study to examine the safety and potential effectiveness of the adult stem cell investigational product, MultiStem, in adults who have suffered an ischemic stroke. The hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.

Condition Intervention Phase
Ischemic Stroke Biological: MultiStem Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke

Further study details as provided by Athersys, Inc:

Primary Outcome Measures:
  • frequency of dose limiting adverse events [ Time Frame: 7 days ]
  • Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI) [ Time Frame: 90 days ]

Secondary Outcome Measures:
  • proportion of subjects with a mRS score of less than or equal to 2 [ Time Frame: 90 days ]
  • change in functional outcome throughout range of mRS scores [ Time Frame: 90 days ]
  • changes in outcome measures (mRS, NIHSS, BI) over time [ Time Frame: 365 days ]
  • proportion of subjects with an excellent functional outcome [ Time Frame: 90 days ]
    • mRS score = 0 to 1; and
    • NIHSS score = 0 to 1; and
    • Barthel Index score = greater than or equal to 95

  • frequency of adverse events [ Time Frame: 365 days ]
  • change in vital signs [ Time Frame: 365 days ]
  • change in safety labs [ Time Frame: 365 days ]
  • frequency of secondary infections [ Time Frame: 365 days ]

Enrollment: 134
Study Start Date: October 2011
Study Completion Date: December 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Low dose MultiStem or Placebo
Biological: MultiStem
single infusion 1-2 days following ischemic stroke
Biological: Placebo
single infusion 1-2 days following ischemic stroke
Experimental: Cohort 2
High dose MultiStem or Placebo
Biological: MultiStem
single infusion 1-2 days following ischemic stroke
Biological: Placebo
single infusion 1-2 days following ischemic stroke
Experimental: Cohort 3
Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
Biological: MultiStem
single infusion 1-2 days following ischemic stroke
Biological: Placebo
single infusion 1-2 days following ischemic stroke

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 83 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects between 18 and 83 years of age (inclusive)
  • Clinical diagnosis of cortical cerebral ischemic stroke
  • Occurrence of a moderate to moderately severe stroke

Exclusion Criteria:

  • Presence of a lacunar or a brainstem infarct
  • Reduced level of consciousness
  • Major neurological event such as stroke or clinically significant head trauma within 6 months of study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436487


  Show 32 Study Locations
Sponsors and Collaborators
Athersys, Inc
Medpace, Inc.
Investigators
Study Director: Robert W Mays, PhD Athersys, Inc
  More Information

Responsible Party: Athersys, Inc
ClinicalTrials.gov Identifier: NCT01436487     History of Changes
Other Study ID Numbers: B01-02
First Submitted: September 15, 2011
First Posted: September 19, 2011
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Athersys, Inc:
ischemic stroke
adult stem cells

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia