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Study to Examine the Effects of MultiStem in Ischemic Stroke

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.
 
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

Tracking Information
First Submitted Date  ICMJE September 15, 2011
First Posted Date  ICMJE September 19, 2011
Last Update Posted Date August 2, 2016
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2011)
  • frequency of dose limiting adverse events [ Time Frame: 7 days ]
  • proportion of subjects with a modified Rankin Scale (mRS) score of less than or equal to 2 [ Time Frame: 90 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2011)
  • change in functional outcome throughout range of mRS scores [ Time Frame: 90 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Examine the Effects of MultiStem in Ischemic Stroke
Official Title  ICMJE Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • Biological: MultiStem
    single infusion 1-2 days following ischemic stroke
  • Biological: Placebo
    single infusion 1-2 days following ischemic stroke
Study Arms  ICMJE
  • 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
Publications * Hess DC, Wechsler LR, Clark WM, Savitz SI, Ford GA, Chiu D, Yavagal DR, Uchino K, Liebeskind DS, Auchus AP, Sen S, Sila CA, Vest JD, Mays RW. Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 May;16(5):360-368. doi: 10.1016/S1474-4422(17)30046-7. Epub 2017 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2016)
134
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2011)
140
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 83 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01436487
Other Study ID Numbers  ICMJE B01-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Athersys, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Athersys, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Medpace, Inc.
Investigators  ICMJE
Study Director: Robert W Mays, PhD Athersys, Inc
PRS Account Athersys, Inc
Verification Date July 2016

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