Actively Recruiting
Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients
Led by Sun Yat-sen University · Updated on 2024-12-18
90
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
G
Guangzhou Cellgenes Biotechnology Co.,Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily agree to join the study and sign informed consent.
- Age 18 years or older, male or female.
- Diagnosis consistent with Guidelines for Diagnosis and Treatment of Liver Failure (2018 edition), including chronic liver disease with serum total bilirubin (TBIL) ≥171 µmol/L or mean daily rise ≥17.1 µmol/L, and at least one of bleeding tendency, hepatic encephalopathy, or hepatorenal syndrome.
- For phase II: liver failure caused by Hepatitis B.
- Model for End Stage Liver Disease (MELD) score below 30.
- No conception or sexual partner conception during the study period and within 6 months after last infusion, with use of effective contraception methods or abstinence as applicable.
- Female participants must have persistent spontaneous menopause >12 months or undergone sterilization, or have a negative pregnancy test within 7 days before first infusion and agree to contraception requirements.
- Male participants must agree to use effective contraception methods or abstain from sexual intercourse during the study and for 6 months after last infusion.
You will not qualify if you...
- Allergy to known components of the study drug or history of severe allergies.
- Severe infections such as septic shock.
- Gastrointestinal bleeding at screening.
- Hepatic encephalopathy grade 4.
- Failure of three or more organs.
- Pregnancy or breastfeeding.
- History of malignant tumors.
- Imaging showing intrahepatic nodular or solid space-occupying lesions.
- History of immunodeficiency diseases including HIV.
- Previous liver transplantation.
- Deep vein thrombosis or pulmonary embolism within 3 months.
- Pulmonary hypertension.
- Myocardial infarction within past 6 months.
- Previous stem cell therapy.
- Participation in another interventional clinical trial within 3 months or 5 half-lives of experimental drugs.
- For phase II: received artificial liver therapy within 7 days before first dose.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
Research Team
B
Bingliang Lin, MD
CONTACT
J
Junfeng Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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