Clinical Trial of CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection in the Treatment of Acute Respiratory Distress Syndrome

NCT07892950 | Completed Phase 1

• 1 other identifier: CGBM1-ARDS-I01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Acute Respiratory Distress Syndrome.
2. 2.To observe the preliminary effectiveness of CG-BM1 in treating Acute Respiratory Distress Syndrome patients.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (2)

• Incidence of DLT.

  14 days after administration

• Incidence of CG-BM1-related AEs and SAEs .

  6 months after administration

Study Arms (3)

CG-BM1- 1.0 × 10^6 cells/kg

EXPERIMENTAL

Administration procedure of CG-BM1: 1.0 × 10\^6 cells/kg as a single administration. Conventional treatment includes, but is not limited to: infection control; respiratory support (e.g., lung-protective ventilation, lung recruitment maneuvers, prone positioning); conservative fluid therapy; hemodynamic management (e.g., vasoactive agents, inotropic agents); corticosteroids; nutritional support; and prevention of complications.

Biological: CG-BM1

CG-BM1- 2.0 × 10^6cells/kg

EXPERIMENTAL

Administration procedure of CG-BM1: 2.0 × 10\^6 cells/kg as a single administration. Conventional treatment includes, but is not limited to: infection control; respiratory support (e.g., lung-protective ventilation, lung recruitment maneuvers, prone positioning); conservative fluid therapy; hemodynamic management (e.g., vasoactive agents, inotropic agents); corticosteroids; nutritiona support; and prevention of complications.

Biological: CG-BM1

CG-BM1- 5.0 × 10^6cells/kg

EXPERIMENTAL

Administration procedure of CG-BM1: 5.0 × 10\^6 cells/kg as a single administration. Conventional treatment includes, but is not limited to: infection control; respiratory support (e.g., lung-protective ventilation, lung recruitment maneuvers, prone positioning); conservative fluid therapy; hemodynamic management (e.g., vasoactive agents, inotropic agents); corticosteroids; nutritiona support; and prevention of complications.

Biological: CG-BM1

Interventions

CG-BM1 BIOLOGICAL

CG-BM1 is administered as a single dose of 1.0 × 10\^6 cells/kg.

CG-BM1- 1.0 × 10^6 cells/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years; male or female.
• Currently receiving mechanical ventilation; confirmed or clinically diagnosed infection-induced moderate-to-severe ARDS; diagnosis of moderate-to-severe ARDS meets the 2012 Berlin Definition.
• No improvement in moderate-to-severe ARDS after 24 hours of conventional clinical treatment. No improvement is defined as PaO2/FiO2 remaining ≤200 mmHg after 24 hours of the above conventional conservative treatment, or from a value above 200 mmHg to ≤200 mmHg; for severe ARDS, this period may be shortened to 8 hours.
• No possibility of conception (or impregnating a sexual partner), childbearing, or breastfeeding during the study period and for 6 months after cell infusion.

You may not qualify if:

• More than 7 days since first meeting ARDS criteria (2012 Berlin Definition) at enrollment.
• Pregnancy or breastfeeding.
• History of malignancy requiring treatment within the past 2 years or malignancy requiring treatment at screening.
• At screening, grade 3 or 4 pulmonary hypertension or severe chronic respiratory disease with PaCO2 \>50 mmHg; history of severe end-stage lung disease.
• At screening, large pleural effusion or atelectasis that is not promptly resolved or rapidly recurs after resolution (chest X-ray showing \>50% unilateral lung atelectasis).
• At screening, severe cardiopulmonary malformation affecting cardiopulmonary function.
• Prior lung transplantation.
• Deep vein thrombosis at screening or history of pulmonary embolism within 3 months before screening.
• Transfusion-related adverse reaction within 4 weeks before admission.
• Active bleeding within the past 24 hours requiring massive transfusion support.
• Cardiac arrest within 4 weeks before admission.
• Positive HIV antibody or positive Treponema pallidum antibody at screening.
• Hepatic failure at screening (MELD score \>30).
• Long-term hemodialysis, known severe renal impairment (estimated glomerular filtration rate \<30 mL/min/1.73 m2), or current use of extracorporeal membrane oxygenation (ECMO).
• Severe cerebral herniation at screening.

Sponsors & Collaborators

• GuangZhou Cellgenes Biotechnology Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

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

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: January 4, 2023
• Primary Completion: June 20, 2024
• Study Completion: December 20, 2025
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

CN (1)