Clinical Research Directory

Ex Vivo Perfusion of Gene-Edited Porcine Livers in Patients With Severe Hepatic Failure

The goal of this clinical trial is to evaluate whether extracorporeal perfusion using a gene-edited pig liver can significantly improve liver function and serve as a bridge-to-transplant therapy in patients with severe hepatic failure. It will also assess the survival and functionality of the xenogeneic liver and monitor the safety of the procedure. The main questions it aims to answer are: * Can extracorporeal perfusion with a gene-edited pig liver significantly improve liver function indicators (including biochemical, coagulation, and metabolic parameters) in patients with severe hepatic failure? * Is the gene-edited pig liver viable and functional during extracorporeal perfusion, as evidenced by bile secretion, adequate blood flow, and acceptable histopathological findings? * What adverse events occur in participants during and after extracorporeal xenogeneic liver perfusion? This is a single-arm study without a comparison group. Participants will: * Undergo screening assessments to confirm eligibility for severe hepatic failure diagnosis * Receive extracorporeal perfusion with a gene-edited pig liver for up to 14 days (or until transplantation/clinical improvement) * Receive intensive immunosuppressive therapy including tacrolimus, rituximab, ATG, mycophenolate mofetil, and other medications to prevent rejection Undergo hourly vital sign monitoring and daily blood tests (liver function, renal function, coagulation, inflammatory markers) during the perfusion period * Have daily abdominal ultrasounds and liver biopsies every other day to assess graft function and rejection

Perioperative Use of Amino Acids in Recipients of Orthotopic Liver Transplantation as a Renal Protective Factor

Orthotopic liver transplantation is the definitive treatment for end-stage liver failure, with renal failure being an important complication of this procedure that has implications for long- and short-term prognosis, affecting ICU stay and hospitalization time. Several studies have suggested that intravenous amino acids, particularly L-arginine, may have protective effects on renal function due to increased renal blood flow, which could be explained by enhanced production of nitric oxide among other mechanisms that are still unclear. In this context, we developed the hypothesis that the infusion of an amino acid solution in the perioperative period could reduce the incidence of acute renal failure in this group of patients; for this, we conducted a monocentric, analytical, prospective, interventional pilot study comparing standard treatment (in historically transplanted patients) with a group of patients who were administered amino acids in the perioperative period, considering that this medication is low-cost and has practically minimal side effects.