Study to Examine the Effects of MultiStem in Ischemic Stroke

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

Tracking Information

• First Submitted Date: September 15, 2011
• First Posted Date: September 19, 2011
• Last Update Posted Date: August 2, 2016
• Study Start Date: October 2011
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Study to Examine the Effects of MultiStem in Ischemic Stroke
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Ischemic Stroke

Intervention

• Biological: MultiStem
  single infusion 1-2 days following ischemic stroke
• Biological: Placebo
  single infusion 1-2 days following ischemic stroke

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2016): 134
• Original Estimated Enrollment (submitted: September 16, 2011): 140
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 83 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom, United States

Administrative Information

• NCT Number: NCT01436487
• Other Study ID Numbers: B01-02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Athersys, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Athersys, Inc
• Original Study Sponsor: Same as current
• Collaborators: Medpace, Inc.

Investigators

• Study Director: Robert W Mays, PhD; Athersys, Inc

• PRS Account: Athersys, Inc
• Verification Date: July 2016