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
1 other identifier
interventional
134
2 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Typical duration for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2011
CompletedFirst Posted
Study publicly available on registry
September 19, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 2, 2016
July 1, 2016
3.4 years
September 15, 2011
July 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
frequency of dose limiting adverse events
7 days
Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)
90 days
Secondary Outcomes (8)
proportion of subjects with a mRS score of less than or equal to 2
90 days
change in functional outcome throughout range of mRS scores
90 days
changes in outcome measures (mRS, NIHSS, BI) over time
365 days
proportion of subjects with an excellent functional outcome
90 days
frequency of adverse events
365 days
- +3 more secondary outcomes
Study Arms (3)
Cohort 1
EXPERIMENTALLow dose MultiStem or Placebo
Cohort 2
EXPERIMENTALHigh dose MultiStem or Placebo
Cohort 3
EXPERIMENTALHighest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healios K.K.lead
- Medpace, Inc.collaborator
Study Sites (32)
UCLA Medical Center
Los Angeles, California, 90095, United States
Stanford University
Stanford, California, 94305, United States
University of Miami
Miami, Florida, 33136, United States
Florida Hospital Orlando
Orlando, Florida, 32803, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Boston University
Boston, Massachusetts, 02118, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2045, United States
Summa Health System
Akron, Ohio, 44320, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Case Western Reserve University School of Medicine
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
The Pennsylvania State University
Hershey, Pennsylvania, 17033-0850, United States
Hospital for the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37403, United States
Methodist Hospital Research Institute
Houston, Texas, 77030, United States
The University of Texas Health Science Center
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Glasgow - Western Infirmary
Glasgow, G11 6NT, United Kingdom
University of Glasgow - Southern General Hospital
Glasgow, G12 8QQ, United Kingdom
St. Georges Healthcare NHS Trust
London, SW17 0QT, United Kingdom
University College London Hospitals - Thames Stroke Research Network
London, WC1E 6BT, United Kingdom
The Newcastle upon Tyne Hospitals, NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (1)
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.
PMID: 28320635DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert W Mays, PhD
Healios K.K.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2011
First Posted
September 19, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2015
Study Completion
December 1, 2015
Last Updated
August 2, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share