Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

January 31, 2026

Conditions
Acute-On-Chronic Liver Failure
Interventions
DRUG

Bone marrow mesenchymal stem cells (low dose)

Administered intravenously. For phase I: single infusion, 1.0×10\^6 cells/kg. For phase II: 1.0×10\^6 cells /kg once a week for a total of 4 times.

DRUG

Solvent of CG-BM1

Administered intravenously, once a week for a total of 4 doses.

DRUG

Bone marrow mesenchymal stem cells (medium dose)

Administered intravenously. For phase I: single infusion, 2.0×10\^6 cells /kg. For phase II: 2.0×10\^6 cells /kg once a week for a total of 4 times.

DRUG

Bone marrow mesenchymal stem cells (high dose)

Administered intravenously. For phase I: single infusion, 4×10\^6 cells /kg.

Trial Locations (1)

510630

RECRUITING

Third Affliated Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
collaborator

Guangzhou Cellgenes Biotechnology Co.,Ltd

UNKNOWN

lead

Sun Yat-sen University

OTHER