Acute Respiratory Distress Syndrome
Conditions
Keywords
Acute respiratory distress syndrome, ARDS, Human Umbilical Cord Mesenchymal Stem Cells
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.
Interventions
BIOLOGICAL1 vial containing a total of 5×10^7 cells
venous reinfusion
BIOLOGICAL2 vial containing a total of 1×10^8 cells
venous reinfusion
BIOLOGICAL3 vial containing a total of 1.5×10^8 cells
venous reinfusion
BIOLOGICAL4 vial containing a total of 2×10^8 cells
venous reinfusion
Sponsors
Changchun Tuohua Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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. * Presence of severe cardiopulmonary malformations at screening. * Severe psychiatric disorders. * Patients who are pregnant (positive pregnancy test), breastfeeding, or have a pregnancy plan, are unwilling to practice contraception during the study and for 12 months after the infusion, or are of childbearing potential and unwilling to use effective contraception. * Use of high-dose corticosteroids equivalent to methylprednisolone \> 240 mg/day within 3 days prior to enrollment, or long-term irregular use of systemic corticosteroids for other diseases, which, in the investigator's judgment, may affect efficacy evaluation. * Allergy to any component of the Human Umbilical Cord Mesenchymal Stem Cell Injection (e.g., human albumin), or a history of severe allergies deemed by the investigator as unsuitable for participation. * Concurrent participation in another interventional clinical trial, or participation in another interventional clinical trial within the 3 months prior to screening. * History or current diagnosis of malignancy, or pathological confirmation of precancerous lesions. * Any other condition that, in the investigator's judgment, would lead to premature termination of the study, such as non-adherence to the protocol, concurrent severe illnesses requiring combined treatment, significant laboratory abnormalities, or social/family factors that could compromise the patient's safety or data collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose | Periprocedural | Safety Indicator |
| Any adverse events related to MSCs therapy | within 28 days after administration | Safety Indicato |
| DLT incidence rate | within 28 days after administration | Safety Indicator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| all-cause mortality | within 28 days after administration | Efficacy Endpoint |
| Time of non-mechanical ventilation (days) | within 28 days after administration | Efficacy Endpoint |
| Non-intensive care time (days) | within 28 days after administration | Efficacy Endpoint |
| Time without organ failure (days) | within 28 days after administration | Efficacy Endpoint |
| Incidence of Clinically Significant Changes in Vital Signs from Baseline | within 28 days after administration | Safety Indicato |
| 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 | Efficacy Endpoint |
| Lung injury score changes from baseline | Days 7, 14, 28 | The minimum score is 0, and the maximum score is 4. A higher score indicates a more severe condition. Efficacy Endpoint |
| PaO2/FiO2 varies from baseline | 24 hours, 3, 7, 14, 28 days after infusion of test drug | Efficacy Endpoint |
| Sequential organ failure score changes from baseline | Days 3, 7, 14, 28 | Minimum score 0, maximum score 24. The higher the score, the worse the prognosis Efficacy Endpoint |
| Incidence of clinically significant changes in laboratory tests from baseline | within 28 days after administration | Safety Indicato |
| male/female tumor marker positive rate | within 28 days after administration | Safety Indicato |
Countries
China
Contacts
CONTACTShi Cheng
PRINCIPAL_INVESTIGATORZhiyong Peng
Zhongnan Hospital
Outcome results
None listed