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Can a single stem cell infusion rewire the brain after stroke?

NCT ID NCT03545607

Disease control Sponsor: Healios K.K. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether a single infusion of MultiStem, an experimental stem cell product, can improve recovery in adults who have had a moderate-to-severe ischemic stroke within the past 18 to 36 hours. The study compares the stem cell treatment against a placebo to see if it reduces long-term disability and improves daily functioning. Participants are adults with a confirmed stroke affecting the brain's cortex, and the main goal is to assess their level of disability three months later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MultiStem, an experimental allogeneic adult stem cell product given as a single intravenous infusion
What this could lead to
If successful, this could provide a new treatment to reduce disability and improve functional recovery after a stroke, potentially helping many patients regain independence.
What could go wrong
This is a phase 3 trial, but the treatment is still experimental. It may not prove more effective than placebo, and there are risks associated with any infusion, including allergic reactions or immune responses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

206 people

The number who actually took part.

Started

Jul 2018

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke

Contacts and locations

Locations

  • Athersys Investigational Site 101

    Houston, Texas, 77030, United States

  • Athersys Investigational Site 102

    Portland, Oregon, 97239, United States

  • Athersys Investigational Site 103

    Augusta, Georgia, 30912, United States

  • Athersys Investigational Site 104

    Cleveland, Ohio, 44195, United States

  • Athersys Investigational Site 105

    Houston, Texas, 77030, United States

  • Athersys Investigational Site 106

    Pittsburgh, Pennsylvania, 15213, United States

  • Athersys Investigational Site 107

    Hershey, Pennsylvania, 17033, United States

  • Athersys Investigational Site 108

    Miami, Florida, 33136, United States

  • Athersys Investigational Site 109

    Akron, Ohio, 44304, United States

  • Athersys Investigational Site 110

    Salt Lake City, Utah, 84112, United States

  • Athersys Investigational Site 111

    Jackson, Mississippi, 39216, United States

  • Athersys Investigational Site 113

    Boston, Massachusetts, 02114, United States

  • Athersys Investigational Site 115

    Chattanooga, Tennessee, 37403, United States

  • Athersys Investigational Site 118

    Columbia, South Carolina, 29203, United States

  • Athersys Investigational Site 119

    Kansas City, Kansas, 66160, United States

  • Athersys Investigational Site 121

    Chicago, Illinois, 60201, United States

  • Athersys Investigational Site 122

    Palo Alto, California, 94304, United States

  • Athersys Investigational Site 124

    Wichita, Kansas, 67214, United States

  • Athersys Investigational Site 125

    Minneapolis, Minnesota, 55455, United States

  • Athersys Investigational Site 127

    Sacramento, California, 95817, United States

  • Athersys Investigational Site 128

    Phoenix, Arizona, 85013, United States

  • Athersys Investigational Site 129

    Clearwater, Florida, 33756, United States

  • Athersys Investigational Site 130

    Toledo, Ohio, 43606, United States

  • Athersys Investigational Site 601

    Taipei, 10002, Taiwan

  • Athersys Investigational Site 602

    Taoyuan City, 33305, Taiwan

  • Athersys Investigational Site 603

    Taichung, 40402, Taiwan

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