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Study to Examine the Effects of MultiStem in Ischemic Stroke

This study is currently recruiting participants.
Verified October 2011 by Athersys, Inc
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Athersys, Inc
ClinicalTrials.gov Identifier:
NCT01436487
First received: September 15, 2011
Last updated: October 21, 2011
Last verified: October 2011
History of Changes

September 15, 2011
October 21, 2011
October 2011
October 2013   (final data collection date for primary outcome measure)
  • frequency of dose limiting adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • proportion of subjects with a modified Rankin Scale (mRS) score of less than or equal to 2 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01436487 on ClinicalTrials.gov Archive Site
  • change in functional outcome throughout range of mRS scores [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • proportion of subjects with an excellent functional outcome [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: Yes ]
  • change in vital signs [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
  • change in safety labs [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
  • frequency of secondary infections [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Examine the Effects of MultiStem in Ischemic Stroke
Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
  • Biological: MultiStem
    single infusion 1-2 days following ischemic stroke
  • Biological: Placebo
    single infusion 1-2 days following ischemic stroke
  • Experimental: Cohort 1
    Low dose MultiStem or Placebo
    Interventions:
    • Biological: MultiStem
    • Biological: Placebo
  • Experimental: Cohort 2
    High dose MultiStem or Placebo
    Interventions:
    • Biological: MultiStem
    • Biological: Placebo
  • Experimental: Cohort 3
    Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
    Interventions:
    • Biological: MultiStem
    • Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
November 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects between 18 and 79 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
Both
18 Years to 79 Years
No
Contact: Medpace Inc (866) 872-2349 recruitment@medpace.com
United States
 
NCT01436487
B01-02
Yes
Athersys, Inc
Athersys, Inc
Medpace, Inc.
Study Director: Robert W Mays, PhD Athersys, Inc
Athersys, Inc
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP