A Phase 2 interventional study of MultiStem and Placebo in Ischemic Stroke, sponsored by Healios K.K.. Completed at 32 sites in 2 countries. Open to participants aged 18 Years to 83 Years. Per ClinicalTrials.gov, last updated 2016-08-02.
Sponsored by Healios K.K. · Phase 2, Interventional, and Treatment
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 134 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Healios K.K. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Low dose MultiStem or Placebo
Biological: MultiStem · Biological: Placebo
High dose MultiStem or Placebo
Biological: MultiStem · Biological: Placebo
Highest, safe MultiStem dose (from Cohorts 1 and 2) or Placebo
Biological: MultiStem · Biological: Placebo
single infusion 1-2 days following ischemic stroke
single infusion 1-2 days following ischemic stroke
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
Plan to share: No
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Invimestrocel
Healios K.K.