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MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

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ClinicalTrials.gov Identifier: NCT03545607
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Athersys, Inc

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 4, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE July 28, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
distribution of modified Rankin Scale (mRS) scores evaluated by shift analysis [ Time Frame: 90 days ]
Change History Complete list of historical versions of study NCT03545607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
  • proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: [ Time Frame: 365 days ]
    mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100]
  • proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: [ Time Frame: 90 days ]
    mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100]
  • proportion of subjects with a mRS score of less than or equal to 2 [scale range 0 to 6] demonstrating the ability to function independently [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
  • proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: [ Time Frame: 365 days ]
    mRS score = 0 to 1; and NIHSS score = 0 to 1; and Barthel Index score = greater than or equal to 95
  • proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: [ 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
  • proportion of subjects with a mRS score of less than or equal to 2 [ Time Frame: 90 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
Official Title  ICMJE MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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 intravenous infusion 18-36 hours after stroke
  • Biological: Placebo
    single intravenous infusion 18-36 hours after stroke
Study Arms  ICMJE
  • Experimental: MultiStem
    1.2 billion cells
    Intervention: Biological: MultiStem
  • Placebo Comparator: Placebo
    Intervention: 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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 6 months of enrollment into the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Athersys Clinical Trials Group (216) 426-3597 masters2@athersys.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03545607
Other Study ID Numbers  ICMJE B01-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Athersys, Inc
Study Sponsor  ICMJE Athersys, Inc
Collaborators  ICMJE Medpace, Inc.
Investigators  ICMJE
Study Director: Robert W Mays, PhD Athersys, Inc
PRS Account Athersys, Inc
Verification Date August 2019

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