Transplantation of Human Fetal Liver Cells for the Treatment of Patients with Chronic Liver Disease

Transplantation of Human Fetal Liver Cells for the Treatment of Patients with Decompensated Liver Cirrhosis - HFLTX

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005628-13-IT

Enrollment

Registered

2013-01-11

Start date

2012-12-19

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cirrhosis MedDRA version: 14.1 Level: HLT Classification code 10019669 Term: Hepatic fibrosis and cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 14.1 Level: PT Classification code 10019641 Term: Hepatic cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 14.1 Level: HLT Classification code 10019664 Term: Hepatic failure and associated disorders System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 14.1 Leve

Interventions

Product Name: human fetal hepatocytes Product Code: NA Pharmaceutical Form: Solution for infusion Other descriptive name: human fetal hepatocytes Concentration unit: ml millilitre(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Clinical diagnosis (evidence of chronic liver disease, presence of ascites and/or esophageal varices upon upper digestive endoscopy and/or ultrasound evidence of portal hypertension) or histological diagnosis of liver cirrhosis of any etiology. b) Liver failure documented by a score = B8 based on the Child-Pugh classification, and MELD score = 15. c) Informed consent to the study signed by the patient. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • MELD score > 28 • Hepatocellular carcinoma (HCC) • Portal vein thrombosis • Serious cardiovascular or respiratory disease, or other medical condition which may threaten patient’s life in the subsequent three months • Admission to the intensive care unit (ICU) • Hemodynamic instability (MAP 2 mg/dl and/or creatinine clearance 35 mmHg) • History of neoplasia • Pregnancy • Non-Sicilian residency • HBV DNA positive • HIV infection • Drug addiction • Age < 18 years • Partecipation in concomitant studies • Transjugular intrahepatic portosystemic shunt (TIPS) placed in the previous three months • Contraindications to the procedure (i.e., related to the splenic artery: aneurysm, kinking, thrombosis, thrombosis; related to the spleen: large angioma).

Design outcomes

Primary

Measure	Time frame
Main Objective: Verify the efficacy of human fetal liver progenitor cell transplantation by monitoring specific and standard parameters of liver function.;Secondary Objective: To evaluate the effects of fetal liver progenitor cell transplantation on portosystemic encephalopathy (also minimal) in patients with liver cirrhosis.;Primary end point(s): - Stabilization or reduction of the MELD score of 25% compared with pretreatment. Evaluation of the response will be made at intervals after the first infusion of hepatocytes, and at the end of the study.;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: Verify the efficacy of human fetal liver progenitor cell transplantation by monitoring specific and standard parameters of liver function.;Secondary Objective: To evaluate the effects of fetal liver progenitor cell transplantation on portosystemic encephalopathy (also minimal) in patients with liver cirrhosis.;Primary end point(s): - Stabilization or reduction of the MELD score of 25% compared with pretreatment. Evaluation of the response will be made at intervals after the first infusion of hepatocytes, and at the end of the study.;Timepoint(s) of evaluation of this end point: 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): Disappearance of systemic encephalopathy (also minimal).;Timepoint(s) of evaluation of this end point: 1 year	—

Countries

Italy

Contacts

Public ContactDipartimento di Medicina

ISMETT

fvenuti@ismett.edu00390912192111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026