Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    240
  • sponsor
    Beijing 302 Hospital
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Updated on 21 November 2021
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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.

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, multicentre, randomised trial to assess treatment with three intravenous doses of MSCs compared with placebo. 240 decompensated cirrhosis patients will be recruited in China.120 patients will receive i.v. transfusion 3 times of MSCs (6.010E7 cells per time) and the standard of care as the treated group. In addition, the 120 patients will receive placebo and standard of care as control group.

Details
Condition Decompensated Cirrhosis
Treatment UC-MSCs, Saline containing 1% Human serum albumin（solution without UC-MSCs）
Clinical Study IdentifierNCT05121870
SponsorBeijing 302 Hospital
Last Modified on21 November 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Willing to provide written informed consent
Aged 18 to 75 years (including 18 and 75 years), male or female
Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and/or representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one serious complication, including esophageal and gastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications)
Child-Turcotte-Pugh (CTP) score 7 to 12 points

Exclusion Criteria

Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to screening visit
Uncontrolled severe infection within 2 weeks of screening
Hepatitis B virus (HBV) DNA detection limit at the time of screening
Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months
Patients with hepatitis C virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HCV for less than 12 months
Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months
Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion
Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion
Severe jaundice (serum total bilirubin level 170mol/L); Significant renal insufficiency (serum creatinine 1.2 times upper normal limit); Severe electrolyte abnormality (serum sodium level < 125 mmol/L); Severe leukopenia (white blood cell count < 1 10E9/L)
Patients with biliary obstruction, hepatic vein, portal vein, splenic vein thrombosis and portal vein spongiosis
Patients with surgical history such as splenic cut-off flow and portal body shunt
Patients with confirmed or suspected malignancies
Patients with a prior history of major organ transplantation or complicated with significant disease of heart, lung, kidney, blood, endocrine and other systems
Drug abuse, drug dependence and patients who receive methadone treatment or with psychosis
HIV seropositivity
Those who have received blood transfusion or other blood products within 1 month prior to screening visit
Pregnancy, lactation or with recent fertility plan
Highly allergic or have a history of severe allergies
Participants in other clinical trials within the last 3 months
Any other clinical condition which the investigator considers would make the patient unsuitable for the trial
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