Human umbilical cord mesenchymal stem cell injection for moderate to severe ARDS

A Phase I-II, Open-label, Single-arm, Dose-escalation Clinical Trial to Evaluate the Safety and Tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Moderate to Severe Acute Respiratory Distress Syndrome

This will test whether a single injection of human umbilical cord mesenchymal stem cells can help adults with moderate to severe ARDS that hasn't improved after standard treatment.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Changchun Tuohua Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07413978 on ClinicalTrials.gov

What this trial studies

Adults aged 18–80 with infectious moderate or severe ARDS that fails to improve after standard care receive a single intravenous dose of human umbilical cord mesenchymal stem cells at one of four escalating dose levels (5×10^7, 1×10^8, 1.5×10^8, or 2×10^8 cells). The phase 1/2 interventional protocol is primarily focused on safety and tolerability, with secondary objectives to explore signals of efficacy and optimal dosing and exploratory objectives to measure immunogenicity and PK/PD. Key exclusions include ARDS caused by COVID-19 and patients with certain active infections or immunodeficiency. Participants are followed for safety and long-term outcomes at Zhongnan Hospital of Wuhan University.

Who should consider this trial

Good fit: Adults 18–80 years old with infectious moderate or severe ARDS whose oxygenation remains poor after at least 24 hours of standard supportive care (or 8 hours for severe ARDS) and who can provide informed consent are the intended participants.

Not a fit: Patients with ARDS caused by COVID-19 or with active infections such as hepatitis B/C, tuberculosis, HIV/AIDS, syphilis, or documented immunodeficiency are excluded and would not be eligible for potential benefit from this protocol.

Why it matters

Potential benefit: If successful, the injection could reduce lung injury, improve oxygenation, and shorten time on ventilatory support or decrease mortality in patients with severe ARDS.

How similar studies have performed: Previous small trials of mesenchymal stem cells in ARDS have generally shown acceptable safety and some preliminary signs of benefit, but evidence is still limited and not definitive.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Zhiyong Peng — Zhongnan Hospital
• Study coordinator: Shi Cheng

Conditions Acute Respiratory Distress Syndrome; Acute respiratory distress syndrome; ARDS; Human Umbilical Cord Mesenchymal Stem Cells