Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis
NCT ID: NCT05121870
Last Updated: 2021-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
240 participants
INTERVENTIONAL
2021-09-01
2023-12-31
Brief Summary
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Detailed Description
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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 (6.0×10E7 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Human Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs)
standard of care (SOC) plus UC-MSCs
UC-MSCs
3 does of UC-MSCs(6.0×10E7cells per time) intravenously at week 0, week 4, week 8.
Placebo
SOC plus placebo.
Saline containing 1% Human serum albumin（solution without UC-MSCs）
3 does of placebo intravenously at week 0, week 4, week 8.
Interventions
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UC-MSCs
3 does of UC-MSCs(6.0×10E7cells per time) intravenously at week 0, week 4, week 8.
Saline containing 1% Human serum albumin（solution without UC-MSCs）
3 does of placebo intravenously at week 0, week 4, week 8.
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 75 years (including 18 and 75 years), male or female;
3. 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);
4. Child-Turcotte-Pugh (CTP) score 7 to 12 points.
Exclusion Criteria
2. Uncontrolled severe infection within 2 weeks of screening.
3. Hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening.
4. 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.
5. 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.
6. Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
7. Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.
8. Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.
9. Severe jaundice (serum total bilirubin level ≥ 170μmol/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).
10. Patients with biliary obstruction, hepatic vein, portal vein, splenic vein thrombosis and portal vein spongiosis.
11. Patients with surgical history such as splenic cut-off flow and portal body shunt.
12. Patients with confirmed or suspected malignancies.
13. Patients with a prior history of major organ transplantation or complicated with significant disease of heart, lung, kidney, blood, endocrine and other systems.
14. Drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.
15. HIV seropositivity.
16. Those who have received blood transfusion or other blood products within 1 month prior to screening visit.
17. Pregnancy, lactation or with recent fertility plan.
18. Highly allergic or have a history of severe allergies.
19. Participants in other clinical trials within the last 3 months.
20. Any other clinical condition which the investigator considers would make the patient unsuitable for the trial.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Changzheng Hospital
OTHER
LanZhou University
OTHER
Renmin Hospital of Wuhan University
OTHER
Chinese PLA General Hospital
OTHER
Vcanbio Cell and Gene Engineering Corp., Ltd.
INDUSTRY
Beijing 302 Hospital
OTHER
Responsible Party
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Fu-Sheng Wang
Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor
Principal Investigators
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Fu-Sheng Wang, MD, PhD
Role: STUDY_CHAIR
Beijing 302 Hospital
Locations
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The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Hainan hospital of Chinese PLA General Hospital
Sanya, Hainan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Beijing 302 Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Xun Li
Role: primary
Ya-Li Zhao
Role: primary
Ying-an Jiang
Role: primary
Wei-Fen Xie, MD, PhD
Role: primary
Lei Shi, MD,PhD
Role: primary
Other Identifiers
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NCRC-ID202105
Identifier Type: -
Identifier Source: org_study_id