Actively Recruiting
A Phase I-II Open-label Dose-escalation Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for Moderate to Severe Acute Respiratory Distress Syndrome
Led by Changchun Tuohua Pharmaceutical Co., Ltd. · Updated on 2026-02-17
36
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and tolerability of human umbilical cord mesenchymal stem cell injections for adults aged 18 to 80 with moderate to severe acute respiratory distress syndrome ARDS caused by infection. This Phase I-II open-label trial also explores the appropriate dosage, potential effects on the immune system, and how the treatment behaves in the body over time. Participants receive a single dose of stem cells delivered through a vein, with doses ranging from 5 x 107 to 2 x 108 cells. The study does not include a placebo group and focuses on dose escalation to assess safety. The trial is sponsored by Changchun Tuohua Pharmaceutical Co., Ltd. During the 28 days following treatment, participants will have their vital signs, lab tests, lung function, organ failure status, and oxygen levels monitored regularly. Researchers will track any side effects, mortality rates, and time spent without mechanical ventilation or intensive care. Long-term follow-up is also part of the study to further assess safety and effects.
CONDITIONS
Brief 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)
- Diagnosed with moderate or severe Acute Respiratory Distress Syndrome caused by infection
- No improvement after 24 hours of standard treatment (or 8 hours for severe cases) with persistent low oxygen levels
- Ability to understand the study and provide written informed consent
- Willingness to comply with study procedures and good compliance
- Agreement to participate in long-term follow-up
You will not qualify if you...
- ARDS caused by COVID-19 infection
- Current hepatitis B, hepatitis C, active or latent tuberculosis, AIDS, syphilis, immunodeficiency, or other immune diseases
- Severe cardiovascular diseases including NYHA class III or higher, uncontrolled myocarditis or valvular disease, malignant arrhythmia needing treatment
- Abnormal liver or kidney function (ALT/AST ≥ 5x ULN, bilirubin ≥ 3x ULN, creatinine ≥ 3x ULN, or undergoing renal replacement therapy)
- Receiving extracorporeal membrane oxygenation (ECMO) therapy
- Severe blood disorders such as bleeding, low platelets, severe anemia, DIC, leukemia
- Severe end-stage respiratory diseases
- Pulmonary hypertension with artery pressure > 70 mmHg
- History of deep vein thrombosis or pulmonary embolism within 6 months
- Post lung transplantation
- Severe cardiopulmonary malformations
- Severe psychiatric disorders
- Pregnant, breastfeeding, planning pregnancy, or unwilling to practice contraception during and 12 months after study
- Use of high-dose corticosteroids recently or irregular long-term use affecting evaluation
- Allergy to stem cell injection components or history of severe allergies
- Participation in another interventional clinical trial within 3 months
- History or current malignancy or precancerous lesions
- Any condition risking safety or data quality as judged by investigator
Research Team
S
Shi Cheng
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