Status:
RECRUITING
Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure
Lead Sponsor:
Beijing 302 Hospital
Collaborating Sponsors:
Shulan (Hang Zhou) Hospital
BeijingYouan Hospital
Conditions:
Acute-On-Chronic Liver Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the...
Detailed Description
Acute-on-chronic liver failure (ACLF) has been proposed to define a distinct syndrome which is characterized by an intense systemic inflammatory response, single- or multiple organ system failures, an...
Eligibility Criteria
Inclusion
- 18 years old ≤ age ≤ 70 years old, gender is not limited.
- Meet the APASL definition of ACLF: acute liver injury in patients with previously diagnosed or undiagnosed chronic liver disease or cirrhosis, manifested as jaundice (total bilirubin levels of 5 mg/dl or more) and coagulopathy (INR of 1.5 or more, or prothrombin activity of less than 40%） complicated within 4 weeks by clinical ascites, encephalopathy, or both.
- Willing to sign the informed consent form.
Exclusion
- Patients with acute kidney injury, upper gastrointestinal hemorrhage, hepatic encephalopathy above grade II (inclusive) or uncontrolled infection at baseline;
- Before the onset of liver failure, the previous indicators of the patient included PLT\<50×10\^9/L or Child-Pugh score\>9;
- Combined with liver cancer or other malignant tumors;
- Patients with previous liver transplantation or planned liver transplantation within 3 months;
- Severe organic disease of primary extrahepatic organs;
- Those who have a history of venous thrombosis or pulmonary embolism are judged by the investigator to be ineligible to participate in this trial;
- Pregnant, breastfeeding women or those who plan to have a baby in the near future;
- Those who are highly allergic or have a history of severe allergies;
- Those who have received immunosuppressant and immune enhancer treatment within 1 month;
- Drug abuse in the past 5 years;
- Alcohol withdrawal symptoms;
- A history of severe mental disorders within 24 months before screening, including uncontrolled major depression or controlled or uncontrolled psychosis;
- Those who have participated or are participating in other clinical trials within three months before screening, or have previously received stem cell therapy;
- Other conditions that the investigator thinks that the patient is not suitable to participate in this study.
Key Trial Info
Start Date :
September 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05985863
Start Date
September 30 2023
End Date
December 30 2028
Last Update
May 7 2024
Active Locations (1)
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1
the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039