Cord stem cells tested for Life-Threatening lung failure
NCT ID NCT07413978
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether stem cells from umbilical cords are safe for people with moderate to severe acute respiratory distress syndrome (ARDS), a serious lung condition. About 36 adults will receive an injection of these cells to find the safest dose and check for side effects. The goal is to see if this approach can help control the disease and improve outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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: * Male or female patients aged 18 to 80 years (inclusive). * Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to A New Global Definition of Acute Respiratory Distress Syndrome, with an infectious etiology. * No improvement after 24 hours of conventional clinical treatment (defined as a persistent PaO₂/FiO₂ ratio ≤200 mmHg or a decrease from \>200 mmHg to ≤200 mmHg after 24 hours of conventional supportive therapy; for severe ARDS, this assessment period may be shortened to 8 hours). * Ability to fully understand the nature of the study and voluntarily provide written informed consent. * Willingness to comply with all study procedures and demonstrate good compliance during the study period. * Agreement to participate in long-term follow-up. Exclusion Criteria: * Patients with ARDS caused by COVID-19 infection. * Patients currently suffering from hepatitis B, hepatitis C, active or latent tuberculosis, AIDS, syphilis, immunodeficiency disorders, or other immune system diseases. * Presence of severe cardiovascular diseases at screening, including:Cardiac function classification of NYHA class III or higher.Uncontrolled myocarditis or valvular disease.Malignant arrhythmia requiring pharmacological treatment. * Abnormal liver or renal function at screening meeting any of the following criteria:ALT or AST ≥ 5 × ULN, or total bilirubin ≥ 3 × ULN.Serum creatinine ≥ 3 × ULN, or patients currently undergoing renal replacement therapy (CRRT). * Patients receiving extracorporeal membrane oxygenation (ECMO) therapy at the time of screening. * Severe hematological abnormalities at screening, including: hemorrhagic manifestations, PTA ≤ 40% (or INR ≥ 2.0), severe anemia (Hb \< 60 g/L), moderate or severe thrombocytopenia (PLT \< 50 × 10\^9/L), disseminated intravascular coagulation (DIC), leukemia, or other hematological abnormalities deemed ineligible for the study. * Severe end-stage respiratory diseases at screening. * Pulmonary hypertension with a pulmonary artery pressure \> 70 mmHg. * History of deep vein thrombosis or pulmonary embolism within the 6 months prior to enrollment. * Patients post lung transplantation. * Presence of severe cardiopulmonary malformations at screening. * Severe psychiatric disorders. * Patients who are pregnant (positive pregnancy test), breastfeeding, or have a pregnancy plan, are unwilling to practice contraception during the study and for 12 months after the infusion, or are of childbearing potential and unwilling to use effective contraception. * Use of high-dose corticosteroids equivalent to methylprednisolone \> 240 mg/day within 3 days prior to enrollment, or long-term irregular use of systemic corticosteroids for other diseases, which, in the investigator's judgment, may affect efficacy evaluation. * Allergy to any component of the Human Umbilical Cord Mesenchymal Stem Cell Injection (e.g., human albumin), or a history of severe allergies deemed by the investigator as unsuitable for participation. * Concurrent participation in another interventional clinical trial, or participation in another interventional clinical trial within the 3 months prior to screening. * History or current diagnosis of malignancy, or pathological confirmation of precancerous lesions. * Any other condition that, in the investigator's judgment, would lead to premature termination of the study, such as non-adherence to the protocol, concurrent severe illnesses requiring combined treatment, significant laboratory abnormalities, or social/family factors that could compromise the patient's safety or data collection.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongnan Hospital of Wuhan University
RECRUITINGWuhan, Hubei, China
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