Could umbilical cord stem cells save lungs in ARDS?
NCT ID NCT03042143
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
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129 people
The number who actually took part.
- Started
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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
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16 years and older
- Sex
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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 Hide 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.
- Can donated immune cells calm the cytokine storm?
- Steroid dose showdown: can more dexamethasone save lives in respiratory failure?
- Breathing machine settings put to the test in severe lung injury
- The hidden breath: how a mismatch between patient and machine may shape ARDS recovery
- Scientists hunt for hidden subgroups in sudden respiratory failure
- AI plus ultrasound could catch heart and lung decline before it turns critical