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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
134
frequency of dose limiting adverse events
Time frame: 7 days
Stroke recovery based on global test analysis including modified Rankin Scale (mRS), NIHSS, and Barthel Index (BI)
Time frame: 90 days
proportion of subjects with a mRS score of less than or equal to 2
Time frame: 90 days
change in functional outcome throughout range of mRS scores
Time frame: 90 days
changes in outcome measures (mRS, NIHSS, BI) over time
Time frame: 365 days
proportion of subjects with an excellent functional outcome
* mRS score = 0 to 1; and * NIHSS score = 0 to 1; and * Barthel Index score = greater than or equal to 95
Time frame: 90 days
frequency of adverse events
Time frame: 365 days
change in vital signs
Time frame: 365 days
change in safety labs
Time frame: 365 days
frequency of secondary infections
Time frame: 365 days
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...and 22 more locations