Clinical Trials Logo

Clinical Trial Summary

Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions. This clinical trial is to inspect the efficiency and safety of mesenchymal stem cells (MSCs) therapy for decompensated cirrhosis.


Clinical Trial Description

Decompensated cirrhosis has a high overall mortality rate. Liver transplantation is still the most effective treatment for decompensated cirrhosis. However, the shortage of matched liver sources, high costs, and rejection after liver transplantation restrict the development of liver transplantation. Mesenchymal stem cells (MSC) are a kind of pluripotent stem cells belonging to mesoderm, which mainly exist in connective tissue and organ interstitium. At present, MSC can be isolated and prepared from bone marrow, fat, synovium, bone, muscle, lung, liver, pancreas and amniotic fluid and umbilical cord blood . Due to its wide range of sources and self-proliferation and differentiation ability, MSCs have therapeutic potential for many diseases, including acute and chronic liver diseases. In recent years, our team has carried out a series of clinical trials using umbilical cord-derived MSCs to treat patients with end-stage liver disease, decompensated cirrhosis, primary biliary cholangitis, and status after liver transplantation and found that MSCs therapy can significantly improve patient liver function, reduce post-transplantation rejection, reduce complications, improve quality of life, and improve survival. Other investigators have also found in clinical trials with MSCs from different sources that treatment with MSCs can improve MELD scores or liver function levels to varying degrees. However, some studies have found no significant difference between the treatment group and the control group, and MSCs may differentiate into hepatic stellate cells and have the risk of promoting liver fibrosis, it is believed that MSCs do not favor the improvement of liver function in these studies. Therefore, the therapeutic effects of MSCs need to be further validated by larger multicenter randomized controlled clinical trials. The investigators will do a prospective, double-blind, muliticenter, randomised trial to assess treatment with three intravenous doses of MSCs compared with placebo. 140 decompensated cirrhosis patients will be recruited in China. 70 patients will receive i.v. transfusion 3 times of MSCs and the standard of care as the treated group. In addition, the 70 patients will receive placebo and standard of care as control group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05224960
Study type Interventional
Source Beijing 302 Hospital
Contact Lei Shi, MD,PhD
Phone 86-10-66949623
Email shilei302@126.com
Status Not yet recruiting
Phase Phase 2
Start date June 20, 2024
Completion date June 20, 2026

See also
  Status Clinical Trial Phase
Completed NCT01701687 - Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease N/A
Recruiting NCT05121870 - Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis Phase 2
Recruiting NCT05421351 - Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
Not yet recruiting NCT05086536 - Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis
Recruiting NCT03820271 - New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation N/A
Recruiting NCT06134544 - Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis N/A
Recruiting NCT06223893 - CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis N/A
Completed NCT02219477 - A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis Phase 3
Recruiting NCT05734001 - Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures. N/A
Terminated NCT04775329 - Primary Prophylaxis for Spontaneous Bacterial Peritonitis Phase 2/Phase 3
Recruiting NCT04422223 - Prospective Cohort Study of Disease and Outcomes in Cirrhosis
Recruiting NCT02786017 - Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis Phase 1/Phase 2
Completed NCT01326949 - Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis N/A
Recruiting NCT06396897 - Hospital @ Home Model of Care for Cirrhosis
Not yet recruiting NCT06306781 - A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis N/A
Recruiting NCT05227846 - Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-1) Phase 1
Not yet recruiting NCT05937048 - Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D). N/A
Active, not recruiting NCT03205345 - Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis Phase 2
Terminated NCT03462576 - Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17
Terminated NCT04112199 - A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites Phase 2