Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRenJi Hospital
About this trial
This is a prospective single-center dose escalation study of the administration of the microencapsulated hepatocyte therapy in adult liver failure. The purpose of the study is to determine the maximum tolerated dose of microencapsulated hepatocytes in liver failure patients and its effectiveness in treating the disease. We previously generated proliferating human hepatocytes (ProliHH) through dedifferentiation of PHH and engineered them into encapsulated liver organoids (eLO), providing an unlimited cell source for hepatocyte transplantation.
Eligibility criteria
Qualifiers
Body weight>40kg;
Aged between 18 to 65 years old;
Serum Total bilirubin was higher than the normal range and lower than 10 times the upper limit of normal value (ULN);
With or without significantly decreased serum albumin value, lower than 35;
Disqualifiers
With obvious brain edema, cerebral hernia, or indicated intracranial hemorrhage;
Diagnosed or suspected as primary or metastatic liver cancer;
With uncorrectable oxygenation index (PaO2/FiO2)<200;
With disseminated intravascular coagulation;
Trial design
Treatments tested in this trial
- a single course of micro-encapsulated hepatocytes intraperitoneal transplantation therapy
Treatment groups
10 Participants
are divided into 4 treatment groupsSponsors and collaborators
RenJi Hospital
Lead sponsor
Shanghai Institute of Biochemistry and Cell Biology
Collaborator
Source ClinicalTrials.gov