Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT05727722

Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults

Led by RenJi Hospital · Updated on 2025-06-27

10

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

R

RenJi Hospital

Lead Sponsor

S

Shanghai Institute of Biochemistry and Cell Biology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body weight greater than 40 kg
  • Age between 18 and 65 years old
  • For chronic liver failure group: progressive liver function decline or decompensation after cirrhosis
  • Serum total bilirubin above normal but less than 10 times the upper limit of normal
  • May have decreased serum albumin below 35
  • May have decreased platelet count or prothrombin activity ≤40% (or INR ≥1.5) excluding other causes
  • May have refractory ascites or portal hypertension
  • May have stage I or II hepatic encephalopathy
  • No improvement after more than 3 days of regular clinical treatment
  • For acute-on-chronic liver failure group: acute liver failure syndrome with known or unknown liver disease
  • Obvious fatigue with gastrointestinal symptoms like anorexia, vomiting, or abdominal distension
  • Ascites and/or hepatic encephalopathy within 4 weeks of diagnosis
  • Progressive worsening of jaundice with total serum bilirubin ≥85 µmol/L
  • Coagulation disorders with INR >1.5 or prothrombin activity <40%
  • No improvement after more than 3 days of regular clinical treatment
Not Eligible

You will not qualify if you...

  • Presence of brain edema, cerebral hernia, or intracranial hemorrhage
  • Diagnosis or suspicion of primary or metastatic liver cancer
  • Uncorrectable oxygenation index (PaO2/FiO2) less than 200
  • Disseminated intravascular coagulation
  • Active bleeding
  • Uncontrollable infection including spontaneous bacterial peritonitis
  • Uncorrectable platelet count decrease (<20 x 10⁹/L)
  • Positive for HIV or SARS-CoV-1
  • Drug abuse within the past year
  • Systemic hemodynamic instability
  • Pregnancy or breastfeeding
  • Other conditions excluded by the clinician

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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