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Stem cell infusion may help severely ill COVID-19 patients breathe

NCT ID NCT04367077

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests whether an experimental stem cell therapy called MultiStem can help people with moderate to severe acute respiratory distress syndrome (ARDS) caused by infections like COVID-19. ARDS is a serious lung condition that often requires a breathing tube and ventilator. The study will compare MultiStem against a placebo to see if it increases the number of days patients are free from a ventilator and improves survival.

What this could mean

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

Active substance
MultiStem (a stem cell therapy given as an intravenous infusion)
What this could lead to
If it works, this could offer a new treatment to reduce time on ventilators and improve survival for people with severe lung injury from infections like COVID-19.
What could go wrong
This is an early-to-mid-stage trial, so the therapy may not prove effective or safe. Possible risks include infusion reactions or other side effects.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

206 people

The number who actually took part.

Started

Apr 2020

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 to 89 years

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.

Inclusion Criteria: Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria, requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or systemic infection Exclusion Criteria: Moribund subject who, in the opinion of the Investigator, is not expected to survive at least 48 hours and End-stage severe chronic lung disease

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome COVID-19 Dyspnea

As listed by the trial registrant

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

ARDS

Contacts and locations

Locations

  • Athersys Investigational Site 101

    Cleveland, Ohio, 44106, United States

  • Athersys Investigational Site 102

    Cleveland, Ohio, 44109, United States

  • Athersys Investigational Site 103

    Akron, Ohio, 44304, United States

  • Athersys Investigational Site 107

    Chicago, Illinois, 60601, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.