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
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Among 480 studies in Ischemic Stroke with a site in United States — 122 open to participants now, 146 under way, 13 of them phase 3. Ischemic Stroke · United States.
Among the 480 studies in Ischemic Stroke with a site in United States, this one is the 98th largest by enrollment of the 364 interventional ones that give a count, is one of 27 that started in 2018, is one of 33 in phase 3, and was the 216th registered.
2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.
Browse Ischemic Stroke studies →122 of the 480 studies in Ischemic Stroke with a site in United States are open now. Recruiting first, the newest first:
Casa Colina Hospital and Centers for Healthcare · Sites in United States
Ages 18+
Magnetic Tides · Sites in United States
Ages 18–80
Vanderbilt University Medical Center · Sites in United States
Ages 18+
Abrexa Pharmaceuticals, Inc. · Sites in United States
Ages 18–90
Medtronic Neurovascular Clinical Affairs · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
480 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 56 · Phase 2 103 · Phase 3 46 · Phase 4 11
First in 1993; this study’s year is marked. 27 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 206 is above the median of 120 across 1,780 interventional studies indexed under Ischemic Stroke.
Median enrollment 66 across the 364 interventional studies, 300 across the 111 observational. Of the 281 that completed or were terminated, 128 (46%) have results posted.
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154 of 480 have an industry lead sponsor. The 10 most frequent:
Healios K.K. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Healios K.K. has 2 studies filed under Ischemic Stroke — fewer than ten, so there is no comparison to draw.
48 of the studies in Ischemic Stroke with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT03223220Phase 3Lower Merion Neurology Research FoundationQuelling of Excitotoxicity in Acute Stroke With Ketamine | 2026-12-31 |
| NCT05691244Phase 3Pharmazz, Inc.Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | 2027-09 |
| NCT07649135University of MinnesotaFeasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke | 2026-11-30 |
| NCT05085210Beth Israel Deaconess Medical CenterImproving Visual Field Deficits With Noninvasive Brain Stimulation | 2026-12 |
Add all 48 to your calendar (.ics) → With an account.
Among the 480 studies in Ischemic Stroke with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Jul 2018 to primary completion in Oct 2024, 74 months.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Invimestrocel
Healios K.K.