A Phase 3 interventional study of MultiStem and Placebo in Ischemic Stroke, sponsored by Healios K.K.. Terminated at 26 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Healios K.K. · Phase 3, Interventional, and Treatment
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.
Primary Inclusion Criteria:
Primary Exclusion Criteria:
1.2 billion cells
Biological: MultiStem
Biological: Placebo
single intravenous infusion 18-36 hours after stroke
single intravenous infusion 18-36 hours after stroke
assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis
Time frame: 90 days
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
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 \[scale range 0 to 100\]
Time frame: 365 days
proportion of subjects achieving an excellent functional outcome defined by all of the following criteria:
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 \[scale range 0 to 100\]
Time frame: 90 days
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
Time frame: 90 days
Plan to share: Undecided
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Healios K.K.