Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)
Key facts
- Where
- Beijing, Guangzhou, Kashgar, Lanzhou, Sanya, Shanghai, and Wuhan, ChinaSee the 7 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05224960, who can take part
Where in China
- Beijing 302 HospitalBeijing, ChinaContact: Lei Shi, MD, PhDTaking people
- Third Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Qi ZhangNot yet recruiting
- Xinjiang Kashi Area Number 1 HospitalKashgar, ChinaContact: Fei XiaoNot yet recruiting
- The First Hospital of Lanzhou UniversityLanzhou, ChinaContact: Xun LiNot yet recruiting
- Hainan hospital of Chinese PLA General HospitalSanya, ChinaContact: Ya-Li ZhaoTaking people
- Shanghai Changzheng HospitalShanghai, ChinaContact: Wei-Fen Xie, MD, PhDTaking people
- Jin Yin-tan HospitalWuhan, ChinaContact: Chaolin HuangNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing 302 Hospital
- Trial code
- NCT05224960
- Record updated
- 18 October 2024
- Original description
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.Read full original descriptionShow less
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Decompensated Cirrhosis Patients(MSC-DLC-2)
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.
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; 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; 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; Highly allergic, or have a history of severe allergies, known severe allergies to the investigational drug or any of the excipients; Patients who had previously received stem cell therapy or were intolerant to cell therapy; 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); Against the human immunodeficiency virus antibody (Anti - HIV) or syphilis antibody test results were positive; History of pulmonary embolism; Any other clinical condition which the investigator considers would make the patient unsuitable for the trial; 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); Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion; Patients with biliary obstruction, or portal vein spongiosis; Pregnancy, lactation or with recent fertility plan during the test and 6 months after the test; The proposed line of liver transplants within three months; Participants in other clinical trials within the last 3 months.