A Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Severe Acute Respiratory Distress Syndrome (ARDS)

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

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 Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Biological: 1 vial containing a total of 5×10^7 cells; Biological: 2 vial containing a total of 1×10^8 cells; Biological: 3 vial containing a total of 1.5×10^8 cells; Biological: 4 vial containing a total of 2×10^8 cells

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shi Cheng; Phone Number: +8618504341228; Email: thswcs@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Zhiyong Peng; Phone Number: +8627-67811807; Email: pengzy5@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human Umbilical Cord Mesenchymal Stem Cells Injection; single-dose	Biological: 1 vial containing a total of 5×10^7 cells; venous reinfusion; Biological: 2 vial containing a total of 1×10^8 cells; venous reinfusion; Biological: 3 vial containing a total of 1.5×10^8 cells; venous reinfusion; Biological: 4 vial containing a total of 2×10^8 cells; venous reinfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT incidence rate	Safety Indicator	within 28 days after administration
Maximum Tolerated Dose	Safety Indicator	Periprocedural
Any adverse events related to MSCs therapy	Safety Indicato	within 28 days after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Clinically Significant Changes in Vital Signs from Baseline	Safety Indicato	within 28 days after administration
Incidence of clinically significant changes in laboratory tests from baseline	Safety Indicato	within 28 days after administration
male/female tumor marker positive rate	Safety Indicato	within 28 days after administration
all-cause mortality	Efficacy Endpoint	within 28 days after administration
Time of non-mechanical ventilation (days)	Efficacy Endpoint	within 28 days after administration
Non-intensive care time (days)	Efficacy Endpoint	within 28 days after administration
Time without organ failure (days)	Efficacy Endpoint	within 28 days after administration
PaO2/FiO2 varies from baseline	Efficacy Endpoint	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	Efficacy Endpoint	24 hours, 3, 7, 14, 28 days after infusion of test drug
Lung injury score changes from baseline	The minimum score is 0, and the maximum score is 4. A higher score indicates a more severe condition. Efficacy Endpoint	Days 7, 14, 28
Sequential organ failure score changes from baseline	Minimum score 0, maximum score 24. The higher the score, the worse the prognosis Efficacy Endpoint	Days 3, 7, 14, 28

Collaborators and Investigators

• Sponsor: Changchun Tuohua Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Zhiyong Peng, Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ARDS; Acute respiratory distress syndrome; Human Umbilical Cord Mesenchymal Stem Cells
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: TH-MSC-ARDS-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No