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

Phase 1

Conditions: MedDRA version: 14.1Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders
liver cirrhosis
MedDRA version: 14.1Level: HLTClassification code 10019669Term: Hepatic fibrosis and cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.1Level: HLTClassification code 10019664Term: Hepatic failure and associated disordersSystem Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.1Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2012-005628-13-IT

Lead Sponsor: ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

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

• 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 < 55 mmHg) • Use of vasoactive drugs (e.g., epinephrine, norepinephrine, vasopressin, dopamine, terlipressine) • Type-1 (acute) hepatorenal syndrome • Levels of serum creatinine >2 mg/dl and/or creatinine clearance <30-40 ml/min • Sepsis, active infection or spontaneous bacterial peritonitis • Gastrointestinal bleeding or recent gastrointestinal bleeding episode (in the previous 4 weeks) • Consumption of alcohol • Serious alcoholic hepatitis • Pulmonary hypertension (PAP > 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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures