Micro‑encapsulated hepatocyte transplant into the abdominal cavity for adults with liver failure

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

This trial will try a single dose of micro‑encapsulated human hepatocytes placed into the abdominal cavity to see if it is safe and helps adults with chronic or acute‑on‑chronic liver failure.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05727722 on ClinicalTrials.gov

What this trial studies

This single‑center, open‑label Phase 1 study uses a dose‑escalation design (accelerated titration followed by 3+3 cohorts) to determine the maximum tolerated dose of micro‑encapsulated hepatocytes delivered intraperitoneally. Investigational cells are proliferating human hepatocytes (ProliHH) engineered into encapsulated liver organoids (eLO) to provide an unlimited cell source for transplantation. Eligible adults with chronic liver failure or acute‑on‑chronic liver failure who have not improved after regular treatment will receive a single course of intraperitoneal transplantation and be followed closely for safety and preliminary efficacy at days 1, 3, 7, 14, 28, and 60. Patients may continue standard clinical care, including listing for or receiving liver transplantation if needed.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–65 who weigh over 40 kg with chronic liver failure or acute‑on‑chronic liver failure who have not improved after at least 3 days of standard treatment and who meet the study's laboratory limits (for example bilirubin under 10×ULN).

Not a fit: Patients unlikely to benefit include those outside the 18–65 age or weight criteria, children, and people with rapidly progressive multi‑organ failure or very severe liver disease beyond the inclusion criteria (for example advanced hepatic encephalopathy or uncontrolled coagulopathy).

Why it matters

Potential benefit: If successful, the therapy could provide a temporary boost to liver function and serve as a bridge to recovery or to definitive treatments like liver transplant.

How similar studies have performed: Prior hepatocyte transplantation and encapsulated‑cell approaches have shown encouraging safety signals and short‑term laboratory improvements in small series, but using ProliHH‑derived encapsulated organoids is a novel approach without large‑scale proof yet.

Eligibility criteria

Inclusion Criteria:

A. Chronic liver failure (CLF) group:

The progressive liver function decline or decompensation after liver cirrhosis:

1. Body weight\>40kg;
2. Aged between 18 to 65 years old;
3. Serum Total bilirubin was higher than the normal range and lower than 10 times the upper limit of normal value (ULN);
4. With or without significantly decreased serum albumin value, lower than 35;
5. With or without significantly decreased platelet (PLT) value, prothrombin activity (PTA)≤40% (or international normalized ratio (INR)≥1.5), other reasons excluded;
6. With or without refractory ascites or portal hypertension;
7. With or without a stage I or II hepatic encephalopathy;
8. 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).

1. Body weight\>40kg;
2. Aged between 18 to 65 years old;
3. With obvious fatigue, accompanied by other gastrointestinal symptoms such as anorexia, vomiting, and abdominal distension;
4. Complicated with ascites and/or hepatic encephalopathy within 4 weeks after being diagnosed;
5. Progressive aggravation of jaundice, total serum bilirubin≥85umol/L；
6. Coagulation disorders, INR\>1.5 or PTA\<40%;
7. No obvious improvement after more than 3 days' regular clinical treatments.

Exclusion Criteria:

1. With obvious brain edema, cerebral hernia, or indicated intracranial hemorrhage;
2. Diagnosed or suspected as primary or metastatic liver cancer;
3. With uncorrectable oxygenation index (PaO2/FiO2)\<200;
4. With disseminated intravascular coagulation;
5. Active hemorrhage;
6. Uncontrollable infection, including ascites infection such as spontaneous bacterial peritonitis;
7. Uncorrectable decrease in PLT (\<20×109/L);
8. HIV and/or SARS-CoV-Ⅱ positive;
9. Drug abuse within 1 year;
10. Systemic hemodynamic instability;
11. Combined with pregnancy or lactation;
12. Other situations excluded by clinician;

Where this trial is running

Shanghai

• Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)

Conditions Acute-On-Chronic Liver Failure; Chronic Liver Failure; cell transplantation; hepatocyte transplantation; micro-encapsulate