Status:
NOT_YET_RECRUITING
Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDS
Lead Sponsor:
Southeast University, China
Collaborating Sponsors:
Zhongda Hospital
Yinguan Biologics, Shenzheng
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 cl...
Eligibility Criteria
Inclusion
- Age greater than 18 years, regardless of gender;
- Meeting the ARDS Berlin diagnostic criteria;
- Definite diagnosis within 72 hours;
- P/F \< 150mmHg;
- Understanding and signing informed consent.
Exclusion
- Women of childbearing potential with a positive serum pregnancy test before medication, pregnant women, or lactating women;
- ARDS directly caused by physical or chemical factors;
- Moderate to severe liver damage (Child-Pugh score \>12);
- Chronic heart failure, New York Heart Association functional class IV;
- Severe kidney disease undergoing renal replacement therapy;
- 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;
- 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;
- Expected survival time of less than 48 hours due to terminal illness;
- Patients diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past three months;
- Patients receiving ECMO therapy;
- Hepatitis B, hepatitis C, syphilis, or HIV infection.
- eGFR \< 30ml/min/BSA;
- ALT \> 5 × ULN;
- Absolute neutrophil count \< 1500/μL;
- 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;
- Subjects deemed unlikely to benefit from the study by the investigator, or deemed unsuitable for participation in this study.
Key Trial Info
Start Date :
July 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06505941
Start Date
July 20 2024
End Date
February 20 2027
Last Update
July 17 2024
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