Liver Cirrhosis | Human Fetal Liver Cell Transplantation in Chronic Liver Failure
Liver Cirrhosis research study
What is the primary objective of this study?
The herein study consists in the transplantation of liver progenitor cells isolated from human fetal liver tissue with the aim of improving conventional liver therapy and broadening therapeutical options other than liver transplantation.
Who is eligible to participate?
Inclusion Criteria: - Clinical diagnosis (evidence of chronic liver disease, presence of ascites and/or esophageal varices upon superior digestive endoscopy and/or ultrasound evidence of portal hypertension) or histological diagnosis of liver cirrhosis with any etiology. - Serious liver failure documented by a score ≥ B8 based on the Child-Pugh-Turcotte classification and/or MELD score ≥ 14. - Informed consent to the study signed by the patient. Exclusion Criteria: - MELD score ≥ 25 - 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 (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 - Active gastrointestinal bleeding or recent gastrointestinal bleeding episode (in the previous 4 weeks) - Active alcohol abuse - Severe alcoholic hepatitis - Pulmonary hypertension (PAP > 35 mmHg) - History of neoplasia - Pregnancy - Non Sicilian residency - HBV DNA positive - HIV infection - Drug addiction - Age < 18 years - Transjugular intrahepatic portosystemic shunt (TIPS) placed in the previous month - Contraindications to the procedure (e.g., related to the splenic artery: aneurysm, kinking, thrombosis, splenic-renal shunt; related to the spleen: large angioma).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Human Fetal Liver Cell TransplantationHuman Fetal Liver Cell Transplantation. Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation. Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance. Cell infusion: between 5 and 10x10^8 cells. Number of sessions: up to 2.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Treated patientsCirrhotic patients treated with Human Fetal Liver Cell Transplantation.
Control patientsCirrhotic patients on Standard therapy.
Start Date: February 2007
Completed Date: July 2011
Phase: Phase 1/Phase 2
Primary Outcome: Patient Survival
Secondary Outcome: Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up
Study sponsors, principal investigator, and references
Principal Investigator: Bruno Gridelli, MD
Lead Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Collaborator: University of Pittsburgh