NCT07413978

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
31mo left

Started Apr 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Apr 2025Dec 2028

Study Start

First participant enrolled

April 25, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

February 2, 2026

Last Update Submit

February 9, 2026

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute respiratory distress syndromeARDSHuman Umbilical Cord Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

Human Umbilical Cord Mesenchymal Stem Cells Injection

EXPERIMENTAL

single-dose

Biological: 1 vial containing a total of 5×10^7 cellsBiological: 2 vial containing a total of 1×10^8 cellsBiological: 3 vial containing a total of 1.5×10^8 cellsBiological: 4 vial containing a total of 2×10^8 cells

Interventions

1 vial containing a total of 5×10^7 cellsBIOLOGICAL

venous reinfusion

Human Umbilical Cord Mesenchymal Stem Cells Injection
2 vial containing a total of 1×10^8 cellsBIOLOGICAL

venous reinfusion

Human Umbilical Cord Mesenchymal Stem Cells Injection
3 vial containing a total of 1.5×10^8 cellsBIOLOGICAL

venous reinfusion

Human Umbilical Cord Mesenchymal Stem Cells Injection
4 vial containing a total of 2×10^8 cellsBIOLOGICAL

venous reinfusion

Human Umbilical Cord Mesenchymal Stem Cells Injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Zhiyong Peng

    Zhongnan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shi Cheng

CONTACT

+8618504341228thswcs@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 17, 2026

Study Start

April 25, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)