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Study to Examine the Effects of MultiStem in Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01436487
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : August 2, 2016
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Athersys, Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Ischemic Stroke Biological: MultiStem Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
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
Study Start Date : October 2011
Primary Completion Date : March 2015
Study Completion Date : December 2015

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. proportion of subjects with a mRS score of less than or equal to 2 [ Time Frame: 90 days ]
  2. change in functional outcome throughout range of mRS scores [ Time Frame: 90 days ]
  3. changes in outcome measures (mRS, NIHSS, BI) over time [ Time Frame: 365 days ]
  4. 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

  5. frequency of adverse events [ Time Frame: 365 days ]
  6. change in vital signs [ Time Frame: 365 days ]
  7. change in safety labs [ Time Frame: 365 days ]
  8. frequency of secondary infections [ Time Frame: 365 days ]


Information from the National Library of Medicine

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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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Athersys, Inc
ClinicalTrials.gov Identifier: NCT01436487     History of Changes
Other Study ID Numbers: B01-02
First Posted: September 19, 2011    Key Record Dates
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