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Cord blood stem cells aim to tame COVID-19 lung crisis

NCT ID NCT04565665

Disease control Sponsor: M.D. Anderson Cancer Center 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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study tests whether infusions of cord blood stem cells can help people with moderate to critical COVID-19 pneumonia. The trial includes 65 adults with COVID-19-related acute respiratory distress syndrome (ARDS). Researchers will compare stem cell treatment plus standard care against standard care alone to see if it improves survival and reduces the need for ventilators.

What this could mean

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

Active substance
cord blood derived mesenchymal stem cells
What this could lead to
If it works, this could point toward a new treatment for severe COVID-19 pneumonia that reduces the need for ventilators and improves survival.
What could go wrong
This is an early phase 1/2 trial with only 65 participants, so results may not apply broadly. Stem cell infusions carry risks of infusion reactions or other serious 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Inclusion Criteria: 1. Age greater than or equal 18 years. 2. Participants with chest x-ray findings concerning for pneumonia from any cause, with clinical signs suggestive of at least moderate illness such as respiratory rate \>20 breaths per minute or with oxygen saturation less than 93% on room air\*\* 3. Participants with COVID-19 associated pneumonia must meet baseline categorization of Moderate, Severe or Critical COVID-19 per FDA Guidance for Industry COVID-19: Developing Drugs and Biologics Products for Treatment or Prevention, February 2021. 4. Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 5. Participant or legally authorized representative consent. Participants with diminished mental capacity may be allowed on to enroll on the study. 6. Because of the nature of COVID-19, participants enrolled on this study with COVID-19 associated pneumonia may have been previously enrolled in other IND trials for their cancer diagnosis or for COVID-19. These enrollments will not exclude them from enrollment to this study. Exclusion Criteria: * Moribund participants not expected to survive up to 48 hours * Participants with severe chronic liver disease (Childs-Pugh score \> 10) * Pregnant and/or lactating women * Participants on extracorporeal membrane oxygenation

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome cancer COVID-19 hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm pneumonia

As listed by the trial registrant

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

COVID-19 infection COVID-19-associated acute respiratory distress syndrome Hematopoietic and lymphoid cell neoplasm Malignant solid neoplasm Symptomatic COVID-19 infection laboratory-confirmed

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

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