NCT07413978
Recruiting
Phase 1
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
Changchun Tuohua Pharmaceutical Co., Ltd.1 site in 1 country36 target enrollmentStarted: April 25, 2025Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Changchun Tuohua Pharmaceutical Co., Ltd.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- DLT incidence rate
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Human Umbilical Cord Mesenchymal Stem Cells Injection
Experimental
single-dose
Intervention: 3 vial containing a total of 1.5×10^8 cells (Biological)
Human Umbilical Cord Mesenchymal Stem Cells Injection
Experimental
single-dose
Intervention: 1 vial containing a total of 5×10^7 cells (Biological)
Human Umbilical Cord Mesenchymal Stem Cells Injection
Experimental
single-dose
Intervention: 2 vial containing a total of 1×10^8 cells (Biological)
Human Umbilical Cord Mesenchymal Stem Cells Injection
Experimental
single-dose
Intervention: 4 vial containing a total of 2×10^8 cells (Biological)
Outcomes
Primary Outcomes
DLT incidence rate
Time Frame: within 28 days after administration
Safety Indicator
Maximum Tolerated Dose
Time Frame: Periprocedural
Safety Indicator
Any adverse events related to MSCs therapy
Time Frame: within 28 days after administration
Safety Indicato
Secondary Outcomes
- Incidence of Clinically Significant Changes in Vital Signs from Baseline(within 28 days after administration)
- Incidence of clinically significant changes in laboratory tests from baseline(within 28 days after administration)
- male/female tumor marker positive rate(within 28 days after administration)
- all-cause mortality(within 28 days after administration)
- Time of non-mechanical ventilation (days)(within 28 days after administration)
- Non-intensive care time (days)(within 28 days after administration)
- Time without organ failure (days)(within 28 days after administration)
- PaO2/FiO2 varies from baseline(24 hours, 3, 7, 14, 28 days after infusion of test drug)
- Arterial blood gas analysis (pH, PaO _ 2, PaCO _ 2, Lac) changed from baseline(24 hours, 3, 7, 14, 28 days after infusion of test drug)
- Lung injury score changes from baseline(Days 7, 14, 28)
- Sequential organ failure score changes from baseline(Days 3, 7, 14, 28)
Investigators
Study Sites (1)
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