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A Phase I Safety and Tolerability Dose Escalation Study of Micro-encapsulated Hepatocytes Intraperitoneal Transplantation Therapy for Adult Liver Failure Patients.

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ A. Chronic liver failure (CLF) group:

⁃ The progressive liver function decline or decompensation after liver cirrhosis:

• 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;

• With or without significantly decreased platelet (PLT) value, prothrombin activity (PTA)≤40% (or international normalized ratio (INR)≥1.5), other reasons excluded;

• With or without refractory ascites or portal hypertension;

• With or without a stage I or II hepatic encephalopathy;

• No obvious improvement after more than 3 days' regular clinical treatments.

⁃ OR B. Acute-on-chronic liver failure (ACLF) group:

⁃ With known or unknown basic liver diseases, subjects undergoing acute liver failure syndrome (clinical manifestations indicated as an early stage liver failure).

• Body weight\>40kg;

• Aged between 18 to 65 years old;

• With obvious fatigue, accompanied by other gastrointestinal symptoms such as anorexia, vomiting, and abdominal distension;

• Complicated with ascites and/or hepatic encephalopathy within 4 weeks after being diagnosed;

• Progressive aggravation of jaundice, total serum bilirubin≥85umol/L;

• Coagulation disorders, INR\>1.5 or PTA\<40%;

• No obvious improvement after more than 3 days' regular clinical treatments.

Locations
Other Locations
China
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 10
Treatments
Experimental: Micro-encapsulated Hepatocyte Intraperitoneal Transplantation Cohort 1
Participants will each be administered the dosage of 0.15×10\^9 for one time, with 60 days follow-up after the cell infusion.
Experimental: Micro-encapsulated Hepatocyte Intraperitoneal Transplantation Cohort 2
Participants will each be administered the dosage of 0.5×10\^9 for one time, with 60 days follow-up after the cell infusion.
Experimental: Micro-encapsulated Hepatocyte Intraperitoneal Transplantation Cohort 3
Participants will each be administered the dosage of 1.5×10\^9 for one time, with 60 days follow-up after the cell infusion.
Experimental: Micro-encapsulated Hepatocyte Intraperitoneal Transplantation Cohort 4
Participants will each be administered the dosage of 4.5×10\^9 for one time, with 60 days follow-up after the cell infusion.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Institute of Biochemistry and Cell Biology
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov