Status:
RECRUITING
Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)
Lead Sponsor:
Beijing 302 Hospital
Collaborating Sponsors:
Chinese PLA General Hospital
Shanghai Changzheng Hospital
Conditions:
Decompensated Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 mese...
Detailed 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...
Eligibility Criteria
Inclusion
- 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);
- The Model for End-stage Liver Disease (MELD) score 15 to 30 points.
Exclusion
- 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.
- 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, or hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening.
- 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, or hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening (except HCV RNA\< detection limit without any antiviral treatment).
- 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.
- 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, or portal vein spongiosis.
- Patients with surgical history such as splenic cut-off flow.
- Patients with malignant tumors within 5 years, except those with basal cell carcinoma, squamous cell carcinoma and/or carcinoma in situ who had received curative treatment and curative resection.
- 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.
- Against the human immunodeficiency virus antibody (Anti - HIV) or syphilis antibody test results were positive.
- Pregnancy, lactation or with recent fertility plan during the test and 6 months after the test.
- Highly allergic, or have a history of severe allergies, known severe allergies to the investigational drug or any of the excipients.
- History of pulmonary embolism.
- Patients who had previously received stem cell therapy or were intolerant to cell therapy.
- The proposed line of liver transplants within three months.
- 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.
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05224960
Start Date
June 27 2024
End Date
June 20 2027
Last Update
October 18 2024
Active Locations (7)
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1
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
2
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
3
Hainan hospital of Chinese PLA General Hospital
Sanya, Hainan, China
4
Jin Yin-tan Hospital
Wuhan, Hubei, China