Actively Recruiting
A Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Severe Acute Respiratory Distress Syndrome
Led by Changchun Tuohua Pharmaceutical Co., Ltd. · Updated on 2026-02-17
36
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary Objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Secondary Objectives: To explore the efficacy and appropriate dosage of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Exploratory Objective: To explore the immunogenicity and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single dose of human umbilical cord mesenchymal stem cell injection in patients with moderate/severe acute respiratory distress syndrome.
CONDITIONS
Official Title
A Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Severe Acute Respiratory Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 80 years (inclusive).
- Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) with an infectious cause.
- No improvement after 24 hours of conventional treatment, defined as persistent low oxygenation (PaO2/FiO2 ratio 60;200 mmHg) or deterioration after therapy; for severe ARDS, assessment may be shortened to 8 hours.
- Ability to fully understand the study and provide written informed consent.
- Willingness to follow all study procedures and show good compliance.
- Agreement to participate in long-term follow-up.
You will not qualify if you...
- ARDS caused by COVID-19 infection.
- Active infections such as hepatitis B, hepatitis C, active or latent tuberculosis, AIDS, syphilis, immunodeficiency disorders, or other immune diseases.
- Severe cardiovascular diseases including NYHA class III or higher, uncontrolled myocarditis or valvular disease, malignant arrhythmia needing treatment.
- Significant liver or kidney dysfunction (ALT or AST 65 5 times upper limit, bilirubin 65 3 times upper limit, serum creatinine 65 3 times upper limit, or on renal replacement therapy).
- Receiving extracorporeal membrane oxygenation (ECMO) therapy at screening.
- Severe blood abnormalities such as bleeding, low platelet count, severe anemia, disseminated intravascular coagulation, leukemia, or other disqualifying hematological conditions.
- Severe end-stage respiratory diseases.
- Pulmonary hypertension with artery pressure over 70 mmHg.
- History of deep vein thrombosis or pulmonary embolism within 6 months.
- Post lung transplantation.
- Severe cardiopulmonary malformations.
- Severe psychiatric disorders.
- Pregnancy, breastfeeding, planning pregnancy, unwillingness to use contraception during study and 12 months after.
- Recent use of high-dose corticosteroids or irregular long-term use affecting evaluation.
- Allergy to study drug components or history of severe allergies.
- Participation in another interventional trial currently or within past 3 months.
- History or current cancer or precancerous lesions.
- Other medical or social factors that may cause early study termination or safety risks.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
Research Team
S
Shi Cheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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