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

ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE0 个研究点目标入组 40 人开始时间: 2013年1月11日最近更新: 2018年2月26日

适应症

试验速览

暂无简介。

•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

•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).

发起方

ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE