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COMPLETED
NCT07892950
PHASE1

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

Sponsor: GuangZhou Cellgenes Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Allogeneic Human Bone Marrow Mesenchymal Stem Cell (CG-BM1) Injection in the Treatment of Moderate-to-Severe Acute Respiratory Distress Syndrome in Adults

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-01-04

Completion Date

2025-12-20

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

CG-BM1

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

BIOLOGICAL

CG-BM1

CG-BM1 is administered as a single dose of 2.0 × 10\^6 cells/kg.

BIOLOGICAL

CG-BM1

CG-BM1 is administered as a single dose of 5.0 × 10\^6 cells/kg.

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China