MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
- Conditions
- Ischemic Stroke
- Interventions
- Biological: PlaceboBiological: MultiStem
- Registration Number
- NCT03545607
- Lead Sponsor
- Healios K.K.
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - MultiStem MultiStem 1.2 billion cells
- Primary Outcome Measures
Name Time Method assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis 90 days
- Secondary Outcome Measures
Name Time Method 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 90 days proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: 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 \[scale range 0 to 100\]
Trial Locations
- Locations (26)
Athersys Investigational Site 104
🇺🇸Cleveland, Ohio, United States
Athersys Investigational Site 129
🇺🇸Clearwater, Florida, United States
Athersys Investigational Site 121
🇺🇸Chicago, Illinois, United States
Athersys Investigational Site 127
🇺🇸Sacramento, California, United States
Athersys Investigational Site 111
🇺🇸Jackson, Mississippi, United States
Athersys Investigational Site 103
🇺🇸Augusta, Georgia, United States
Athersys Investigational Site 118
🇺🇸Columbia, South Carolina, United States
Athersys Investigational Site 602
🇨🇳Taoyuan City, Taiwan
Athersys Investigational Site 119
🇺🇸Kansas City, Kansas, United States
Athersys Investigational Site 109
🇺🇸Akron, Ohio, United States
Athersys Investigational Site 106
🇺🇸Pittsburgh, Pennsylvania, United States
Athersys Investigational Site 124
🇺🇸Wichita, Kansas, United States
Athersys Investigational Site 130
🇺🇸Toledo, Ohio, United States
Athersys Investigational Site 107
🇺🇸Hershey, Pennsylvania, United States
Athersys Investigational Site 108
🇺🇸Miami, Florida, United States
Athersys Investigational Site 113
🇺🇸Boston, Massachusetts, United States
Athersys Investigational Site 125
🇺🇸Minneapolis, Minnesota, United States
Athersys Investigational Site 101
🇺🇸Houston, Texas, United States
Athersys Investigational Site 105
🇺🇸Houston, Texas, United States
Athersys Investigational Site 122
🇺🇸Palo Alto, California, United States
Athersys Investigational Site 128
🇺🇸Phoenix, Arizona, United States
Athersys Investigational Site 110
🇺🇸Salt Lake City, Utah, United States
Athersys Investigational Site 601
🇨🇳Taipei City, Taiwan
Athersys Investigational Site 603
🇨🇳Taichung, Taiwan
Athersys Investigational Site 115
🇺🇸Chattanooga, Tennessee, United States
Athersys Investigational Site 102
🇺🇸Portland, Oregon, United States