Mesenchymal Stem Cells Treatment for Decompensated Liver Cirrhosis
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|ClinicalTrials.gov Identifier: NCT03945487|
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Decompensated Liver Cirrhosis||Biological: umbilical cord-derived mesenchymal stem cell Other: Comprehensive treatment||Phase 2|
Liver cirrhosis represents a late stage of progressive hepatic fibrosis characterized by the formation and accumulation of an extracellular matrix, which leads to the progressive distortion of the hepatic architecture. In China, the most important cause of liver cirrhosis is chronic hepatitis B virus (HBV) infection. Liver cirrhosis usually progresses irreversibly into advanced stage, such as a decompensated stage which is characterized by a series of clinical manifestations, including ascites, variceal hemorrhage, and hepatic encephalopathy with high mortality. Liver transplantation is the only option that can improve the survival of these decompensated liver cirrhosis patients; however, this procedure is associated with several limitations, such as the severe shortage of donor livers, long waiting lists, multiple complications, and high cost. Therefore, it is urgent to find a safe and effective therapeutic approach to decompensated liver cirrhosis.
Animal models have shown that bone marrow-derived MSC (BM-MSC) can ameliorate liver fibrosis and reverse fulminant hepatic failure. In clinical, autologous BM-MSC have significantly improved liver function in patients with liver cirrhosis. A recent research also found that autologous BM-MSC therapy safely improved histological fibrosis and liver function in patients with alcoholic cirrhosis. Allogeneic MSC therapy, such as umbilical cord-derived MSC (UC-MSC), have shown to be safe and beneficial for the patients with liver cirrhosis caused by autoimmune diseases. Our previous studies showed that infusions of UC-MSC significantly improved liver function in decompensated liver cirrhosis and primary biliary cirrhosis (PBC) patients and increased the survival rate in acute-on-chronic liver failure (ACLF) patients. However, the single-center clinical study, the relative small size of the patient cohorts, absence of evaluation on long-term efficacy prevent firm conclusions being made with regard to the safety and efficacy of this treatment in liver diseases.
The purpose of this study is to investigate whether and how UC-MSC can improve the liver function, and the incidence of serious complications in patients with decompensated liver cirrhosis through a multi-center clinical study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Human Unbilical Cord Derived-mesenchymal Stem Cells Treatment for Patients With Decompensated Liver Cirrhosis|
|Estimated Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2023|
|Experimental: Comprehensive treatment plus UC-MSC treatment||
Biological: umbilical cord-derived mesenchymal stem cell
Taken a dose of 1.0*10E6 UC-MSC/kg body weight intravenously three times at 3-week intervals, in addition to comprehensive treatment.
Other: Comprehensive treatment
- Liver function [ Time Frame: 96 weeks ]including the levels of albumin [ALB], prothrombin activity [PTA], total bilirubin [TBIL, and cholinesterase [CHE].
- The incidence of serious complications [ Time Frame: 96 weeks ]including infection, gastrointestinal bleeding, encephalopathy, and hepatorenal syndrome.
- The incidence of adverse events [ Time Frame: 96 weeks ]e.g. fever, allergy, rash, infection
- Disease-free survival time [ Time Frame: 96 weeks ]The length of survival time after first UC-MSC treatment for the patient during the follow-up period.
- Incidence of hepatocellular carcinoma (HCC) events [ Time Frame: 96 weeks ]HCC deveopled in the patient during the follow-up period.
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|Ages Eligible for Study:||18 Years to 69 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 18-69 years;
- Decompensated liver cirrhosis (manifestations including gastrointestinal bleeding, hepatic encephalopathy, and ascites, based on previously stable cirrhosis);
- Positive testing for serum hepatitis B surface antigen (HBsAg) for more than 6 months (chronic hepatitis B patients);
- Written consent.
- Hepatocellular carcinoma or other malignancies;
- Liver cirrhosis caused by other reasons, such as autoimmune diseases, alcocal, drugs and so on;
- Pregnant women;
- The presence of other vital organ severe dysfunction;
- Participate in other studies;
- Lack of a supportive family;
- Refusal to sign the informed consent form.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945487
|Contact: Ming Shiemail@example.com|
|Beijing 302 Hospital||Recruiting|
|Beijing, China, 100039|
|Contact: Ming Shi|
|Study Chair:||Fu-Sheng Wang||Beijing 302 Hospital|
|Responsible Party:||Fu-Sheng Wang, Treatment and Research Center for Infectious Diseases, Beijing 302 Hospital|
|Other Study ID Numbers:||
|First Posted:||May 10, 2019 Key Record Dates|
|Last Update Posted:||May 10, 2019|
|Last Verified:||May 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
mesenchymal stem cells
Digestive System Diseases