Ischemic Stroke
Conditions
Keywords
ischemic stroke, adult stem cells
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.
Interventions
BIOLOGICALMultiStem
single intravenous infusion 18-36 hours after stroke
BIOLOGICALPlacebo
single intravenous infusion 18-36 hours after stroke
Sponsors
Healios K.K.
Medpace, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Inclusion Criteria: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| proportion of subjects achieving an excellent functional outcome defined by all of the following criteria: | 365 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 \[scale range 0 to 100\] |
| 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 | — |
Countries
Taiwan, United States
Contacts
STUDY_DIRECTORRobert W Mays, PhD
Healios K.K.
Outcome results
None listed