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Could umbilical cord stem cells save lungs in ARDS?

NCT ID NCT03042143

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This trial tests whether a single infusion of stem cells from donated umbilical cords can help people with acute respiratory distress syndrome (ARDS), a severe lung condition often seen in intensive care. The study first finds a safe dose, then randomly gives either stem cells or a placebo to 129 patients on ventilators. Researchers will measure lung function and side effects to see if the treatment is promising.

What this could mean

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

Active substance
umbilical cord stem cells
What this could lead to
If it works, this could point toward a new treatment for ARDS, a life-threatening lung condition with few effective options.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants. The stem cell treatment may not improve outcomes or could cause unexpected 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

129 people

The number who actually took part.

Started

Jan 2019

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

16 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. ARDS as defined by the Berlin definition. 1. Onset within 1 week of identified insult. 2. Within the same 24-hour time period i. Hypoxic respiratory failure (PaO2/ FiO2 ratio ≤ 27kPa on PEEP ≥ 5 cmH20) ii. Bilateral infiltrates on chest X-ray consistent with pulmonary oedema not explained by another pulmonary pathology iii. Respiratory failure not fully explained by cardiac failure or fluid overload 2. Patient is receiving invasive mechanical ventilation 3. COVID-19 based on clinical diagnosis or PCR result or other causes of ARDS. Exclusion Criteria: 1. More than 72 hours from the onset of ARDS. 2. Age \< 16 years. 3. Patient is known to be pregnant 4. Major trauma in the prior 3 days. 5. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year. 6. WHO Class III or IV pulmonary hypertension. 7. Venous thromboembolism currently receiving anti-coagulation or within the past 3 months 8. Currently receiving extracorporeal life support (ECLS). 9. Severe chronic liver disease with Child-Pugh score \> 12. 10. DNAR (Do Not Attempt Resuscitation) order (excluding advance directives) in place. 11. Treatment withdrawal imminent within 24 hours. 12. Consent declined. 13. Prisoners. 14. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available. 15. Previously enrolled in the REALIST trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Belfast Health and Social Care Trust, Royal Hospitals

    Belfast, Northern Ireland, BT12 6BA, United Kingdom

More trials for these conditions

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