Status:
UNKNOWN
Clinical Study of Hepatocyte Transplantation for Liver Cirrhosis
Lead Sponsor:
RenJi Hospital
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The Primary Objective: To observe and determine the safety and tolerance of allogeneic hepatocyte transplantation in patients with liver cirrhosis and to establish the maximum-tolerated dose (MTD) and...
Detailed Description
* A traditional 3 + 3 dose escalation design will be implemented. * Successive cohorts of participants (3 or 3+3 participants /cohort) will start on a fixed cell numbers of allogeneic hepatocyte in th...
Eligibility Criteria
Inclusion
- Key
- The age at the time of signing the informed consent from 18 to 70 years old (including the boundary value), both male and female;
- Clinical diagnosis of liver cirrhosis;
- Be able to understand and sign informed consent.
- Key
Exclusion
- Combined with liver cancer or other malignant tumors;
- Patients who can't cooperate;
- Prothrombin time (PT) exceeded the upper limit of normal control for 3-5 seconds or more;
- International normalized ratio (INR) \>1.5;
- PLT\<60×109/L；
- Recently use of anticoagulant or antiplatelet drugs (last 7 days);
- Recently (last 4 weeks) had upper gastrointestinal bleeding or spontaneous celiac inflammation;
- Moderate or large amount of ascites;
- The investigator assesses that the patient is unable or unwilling to comply with the protocol.
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04806581
Start Date
April 20 2021
End Date
March 31 2025
Last Update
March 19 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China, 200127