Acute Respiratory Distress Syndrome
Conditions
Keywords
acute respiratry distress syndrome, human umbilical cord derived mesenchymal stem cell, clinical study
Brief summary
The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases.
Detailed description
The secondary objectives are to observe the preliminary efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. Phase One is an open-label, dose-escalation clinical study. Following safety and tolerability conclusions from Phase One, and upon evaluation and approval by the data safety committee and ethics committee, conduct Phase Two study, which will be a randomized, double-blind, placebo-controlled study. Dosage selection will be based on the safest and most effective dosage determined from Phase One results.
Interventions
umbilical cord mesenchymal stem cell
DRUGPlacebo
non-cell-containing placebo
Sponsors
Zhongda Hospital
Yinguan Biologics, Shenzheng
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than 18 years, regardless of gender; 2. Meeting the ARDS Berlin diagnostic criteria; 3. Definite diagnosis within 72 hours; 4. P/F \< 150mmHg; 5. Understanding and signing informed consent.
Exclusion criteria
1. Women of childbearing potential with a positive serum pregnancy test before medication, pregnant women, or lactating women; 2. ARDS directly caused by physical or chemical factors; 3. Moderate to severe liver damage (Child-Pugh score \>12); 4. Chronic heart failure, New York Heart Association functional class IV; 5. Severe kidney disease undergoing renal replacement therapy; 6. Severe lung disease, Grade III or IV pulmonary hypertension, receiving oxygen therapy or ventilator support for more than one month in the six months prior to screening, end-stage lung disease, or severe physical limitations due to chest wall deformity; 7. Immunodeficiency, receiving immunosuppressive therapy within 2 weeks (except for low-dose corticosteroids), or with lymphoma, leukemia, or acquired immune deficiency syndrome; history of organ transplantation, bone marrow transplantation, or autologous hematopoietic stem cell suppression; 8. Expected survival time of less than 48 hours due to terminal illness; 9. Patients diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past three months; 10. Patients receiving ECMO therapy; 11. Hepatitis B, hepatitis C, syphilis, or HIV infection. 12. eGFR \< 30ml/min/BSA; 13. ALT \> 5 × ULN; 14. Absolute neutrophil count \< 1500/μL; 15. Subjects who have participated in other clinical studies within the past month (excluding those who have not received intervention), or are currently participating in other experimental treatments; 16. Subjects deemed unlikely to benefit from the study by the investigator, or deemed unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. | The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection. | The 28-day mortality of patients receiving umbilical cord mesenchymal stem cell therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. | The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection. | Oxygenation index situation change (PaO2/FiO2) of patients receiving umbilical cord mesenchymal stem cell therapy |
Outcome results
None listed