Study to Examine the Effects of MultiStem in Ischemic Stroke
NCT ID: NCT01436487
Last Updated: 2016-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
134 participants
INTERVENTIONAL
2011-10-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
NCT03545607
Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in Subacute Ischemic Stroke
NCT07197606
A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS
NCT07084012
Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
NCT02448641
Intraarterial Stem Cells in Subacute Ischemic Stroke
NCT03080571
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Low dose MultiStem or Placebo
MultiStem
single infusion 1-2 days following ischemic stroke
Placebo
single infusion 1-2 days following ischemic stroke
Cohort 2
High dose MultiStem or Placebo
MultiStem
single infusion 1-2 days following ischemic stroke
Placebo
single infusion 1-2 days following ischemic stroke
Cohort 3
Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
MultiStem
single infusion 1-2 days following ischemic stroke
Placebo
single infusion 1-2 days following ischemic stroke
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MultiStem
single infusion 1-2 days following ischemic stroke
Placebo
single infusion 1-2 days following ischemic stroke
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical diagnosis of cortical cerebral ischemic stroke
* Occurrence of a moderate to moderately severe stroke
Exclusion Criteria
* Reduced level of consciousness
* Major neurological event such as stroke or clinically significant head trauma within 6 months of study
18 Years
83 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medpace, Inc.
INDUSTRY
Healios K.K.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert W Mays, PhD
Role: STUDY_DIRECTOR
Healios K.K.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
University of Miami
Miami, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Boston University
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Summa Health System
Akron, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University School of Medicine
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
The Pennsylvania State University
Hershey, Pennsylvania, United States
Hospital for the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States
Palmetto Health Richland
Columbia, South Carolina, United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States
Methodist Hospital Research Institute
Houston, Texas, United States
The University of Texas Health Science Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Glasgow - Western Infirmary
Glasgow, , United Kingdom
University of Glasgow - Southern General Hospital
Glasgow, , United Kingdom
St. Georges Healthcare NHS Trust
London, , United Kingdom
University College London Hospitals - Thames Stroke Research Network
London, , United Kingdom
The Newcastle upon Tyne Hospitals, NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B01-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.