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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Factors that affect how well mesenchymal stromal cell (MSC) therapy works for hepatitis B–related acute-on-chronic liver failure.

  This project will look back at people with hepatitis B–related ACLF who received MSC infusions to see which factors affect whether the treatment helps.

  Recruiting Sun Yat-sen University · Guangzhou, Guangdong · NCT07198854

• AS1501 in ACLF: a two-stage dose study in adults with acute-on-chronic liver failure

  This Phase II study tests AS1501 given by injection in adults with early ACLF to see if it’s safe and tolerable and to guide dosing.

  Recruiting Phase 2 Shenzhen Third People's Hospital · Shenzhen, Guangdong · NCT06916585

• TAK-242 and G-CSF in ACLF: a new treatment approach for adults with acute-on-chronic liver failure

  This trial tests whether adding TAK-242, with or without G-CSF, to standard ACLF care helps patients with severe alcoholic hepatitis and ACLF.

  Recruiting Phase 2 Yaqrit Ltd · London, Greater London · NCT06890039

• Using different ROTEM cut-offs to guide blood transfusions before procedures in cirrhosis and ACLF

  This will test whether using relaxed ROTEM cut-offs to decide on blood transfusions reduces the number of transfusions without raising bleeding risk for people with cirrhosis or ACLF and severe coagulopathy who need invasive procedures.

  Recruiting Institute of Liver and Biliary Sciences, India · New Delhi, National Capital Territory of Delhi · NCT06831565

• Ceftazidime-avibactam vs high-dose meropenem for ACLF patients with hospital-acquired infections

  This trial tests whether ceftazidime-avibactam can better treat infections in ACLF patients than high-dose meropenem given in extended infusions, aiming to spare carbapenems if possible.

  Recruiting Institute of Liver and Biliary Sciences, India · New Delhi, National Capital Territory of Delhi · NCT06818565

• Evaluating a new treatment for liver failure and sepsis

  This study is testing a new treatment for people with liver failure and sepsis to see if it can help them survive and improve their organ function.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT06562803

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.