Allogeneic bone marrow-derived mesenchymal stromal cells for hepatitis B virus-related acute-on-chronic liver failure: A randomized controlled trial.
Bing-Liang Lin, Jun-Feng Chen, Wei-Hong Qiu...
https://pubmed.ncbi.nlm.nih.gov/28370357Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
ID05985863
Clinical Research of Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure
Led by Beijing 302 Hospital · Updated on 2024-05-07
150
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Beijing 302 Hospital
Lead Sponsor
S
Shulan (Hang Zhou) Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for treating acute-on-chronic liver failure (ACLF). ACLF is a serious condition marked by severe inflammation, organ failure, and high risk of death within 28 days. Current treatments are limited, and liver transplantation faces challenges like donor shortages and high costs. This trial aims to provide scientific evidence on whether UC-MSC therapy can improve outcomes for ACLF patients. The study is a randomized, double-blind, placebo-controlled trial involving 150 patients with ACLF. Participants are divided into groups receiving either UC-MSC infusions or placebo alongside standard medical treatment. The treatment involves three weekly infusions initially, followed by a second stage where some patients receive two additional UC-MSC infusions or placebo. The UC-MSC doses are given through peripheral intravenous infusion at specific weeks during the treatment period. Participants will be monitored through regular visits for up to one year, with assessments including survival rates without transplantation and any side effects from treatment. Researchers will also measure blood tests such as bilirubin, albumin, blood urea nitrogen, and scores that evaluate liver disease severity. These checks occur at multiple time points to track changes and safety throughout and after the treatment period.
CONDITIONS
Brief Title
Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any gender
- Diagnosed with acute-on-chronic liver failure (ACLF) according to APASL criteria
- Jaundice with total bilirubin 5 mg/dL or higher and coagulopathy (INR 1.5 or more or prothrombin activity less than 40%)
- Complicated within 4 weeks by ascites, encephalopathy, or both
- Willing to sign the informed consent form
You will not qualify if you...
- Acute kidney injury, uncontrolled infection, upper gastrointestinal bleeding, or hepatic encephalopathy above grade II at baseline
- Platelet count below 50 x 10^9/L or Child-Pugh score over 9 before liver failure onset
- Presence of liver cancer or other malignant tumors
- Previous liver transplantation or planned liver transplantation within 3 months
- Severe disease of major organs outside the liver
- History of venous thrombosis or pulmonary embolism as judged ineligible by investigator
- Pregnant, breastfeeding, or planning pregnancy soon
- History of severe allergies or high allergy risk
- Use of immunosuppressants or immune enhancers within 1 month
- Drug abuse in past 5 years
- Alcohol withdrawal symptoms
- Severe mental disorders within 24 months before screening
- Participation in other clinical trials within 3 months or prior stem cell therapy
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 3 weeks
Participants receive standard medical treatment for acute-on-chronic liver failure plus either 3 weekly infusions of hUC-MSC or placebo at weeks 0, 1, and 2.
3 infusion visits (in-person) at weeks 0, 1, and 2
Treatment
Duration - 2 weeks
Surviving participants in the MSC group receive 2 additional weekly infusions of hUC-MSC or placebo at weeks 4 and 5.
2 infusion visits (in-person) at weeks 4 and 5
Follow-up
Duration - Up to 48 weeks after treatment
Participants are monitored for transplantation-free survival and treatment-emergent adverse events with ongoing assessments of liver function and clinical status.
Multiple follow-up visits up to week 53
Trial Site Locations
Total: 1 location
1
the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039
Actively Recruiting
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Research Team
T
Tao Yang, MD
Y
Yanhu Wang, MM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Fernando Comunello Schacher, Annelise Martins Pezzi da Silva, Lucia Mariano da Rocha Silla...
https://pubmed.ncbi.nlm.nih.gov/34395335Combination Treatments of Plasma Exchange and Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation for Patients with Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Clinical Trial in China.
Wen-Xiong Xu, Hong-Liang He, Shun-Wen Pan...
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Ming Shi, Zheng Zhang, Ruonan Xu...
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Yu-Hua Li, Ying Xu, Hua-Mei Wu...
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Deepanshu Maheshwari, Dhananjay Kumar, Rakesh Kumar Jagdish...
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Yulin He, Xingrong Guo, Tingyu Lan...
https://pubmed.ncbi.nlm.nih.gov/34256837Mesenchymal stem cells exosomal let-7a-5p improve autophagic flux and alleviate liver injury in acute-on-chronic liver failure by promoting nuclear expression of TFEB.
Dengna Lin, Hao Chen, Jing Xiong...
https://pubmed.ncbi.nlm.nih.gov/36224178