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

NCT06740149 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-12-18

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection (hereinafter referred to as CG-BM1) can treat acute-on-chronic liver failure (ACLF) patients. Main purposes of this clinical trial are:

* To evaluate the safety and tolerability of CG-BM1 for the treatment of adult patients with ACLF.
* To observe the preliminary effectiveness of CG-BM1 in treating adult ACLF patients, and to provide a basis for subsequent clinical trial protocol design.

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.

Sponsors & Collaborators

  • Guangzhou Cellgenes Biotechnology Co.,Ltd

    collaborator UNKNOWN

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-10-31
Completion
2026-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06740149 on ClinicalTrials.gov