Study to Examine the Effects of MultiStem in Ischemic Stroke
- Conditions
- Ischemic Stroke
- Interventions
- Biological: MultiStemBiological: Placebo
- Registration Number
- NCT01436487
- Lead Sponsor
- Healios K.K.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 MultiStem High dose MultiStem or Placebo Cohort 1 MultiStem Low dose MultiStem or Placebo Cohort 1 Placebo Low dose MultiStem or Placebo Cohort 2 Placebo High dose MultiStem or Placebo Cohort 3 MultiStem Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo Cohort 3 Placebo Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 * mRS score = 0 to 1; and
* NIHSS score = 0 to 1; and
* Barthel Index score = greater than or equal to 95frequency of adverse events 365 days change in vital signs 365 days change in safety labs 365 days frequency of secondary infections 365 days
Trial Locations
- Locations (32)
Summa Health System
🇺🇸Akron, Ohio, United States
Palmetto Health Richland
🇺🇸Columbia, South Carolina, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
University of Miami
🇺🇸Miami, Florida, United States
Boston University
🇺🇸Boston, Massachusetts, United States
The Pennsylvania State University
🇺🇸Hershey, Pennsylvania, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Case Western Reserve University School of Medicine
🇺🇸Cleveland, Ohio, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
University of Pittsburgh Medical Center Health System
🇺🇸Pittsburgh, Pennsylvania, United States
University of Glasgow - Southern General Hospital
🇬🇧Glasgow, United Kingdom
St. Georges Healthcare NHS Trust
🇬🇧London, United Kingdom
Chattanooga Center for Neurologic Research
🇺🇸Chattanooga, Tennessee, United States
University Hospital of North Staffordshire
🇬🇧Stoke-on-Trent, United Kingdom
University of Glasgow - Western Infirmary
🇬🇧Glasgow, United Kingdom
The Newcastle upon Tyne Hospitals, NHS Foundation Trust
🇬🇧Newcastle upon Tyne, United Kingdom
University College London Hospitals - Thames Stroke Research Network
🇬🇧London, United Kingdom
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Stanford, California, United States
Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
The University of Texas Health Science Center
🇺🇸Houston, Texas, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Hospital for the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States