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Monitoring of intraportal liver cell application in children
Jochen Meyburg1, Friederike Hoerster, Jan Schmidt
1Department of General Pediatrics, University Children's Hospital, Heidelberg, Germany. jochen.meyburg@med.uni-heidelberg.de
Insights
Liver cell transplantation (LCT) in children is experimental but feasible. A safety protocol monitoring vital signs, portal vein flow, and pressure showed no adverse events in four pediatric patients.
Area of Science:
- Hepatology
- Pediatric Gastroenterology
- Regenerative Medicine
Background:
- Liver cell transplantation (LCT) shows promise in pediatric liver disease but lacks comprehensive safety data.
- Complications are known from animal and individual patient studies, highlighting the need for safety evaluations in children.
Purpose of the Study:
- To evaluate the safety and feasibility of LCT in pediatric patients.
- To establish and apply a monitoring protocol to mitigate potential risks during LCT.
Main Methods:
- LCT was performed in four children with diverse liver conditions.
- Continuous monitoring of vital signs, portal vein flow (PVF), portal vein pressure (PVP), and liver enzymes was conducted.
- An application protocol with specific discontinuation criteria based on PVF and PVP changes was implemented.
Main Results:
- LCT was successfully applied in all four pediatric patients, including one with acute liver failure.
- No application-related changes in vital signs were observed.
- No clinical signs of portal vein thrombosis, pulmonary embolism, or anaphylactic reactions occurred.
Conclusions:
- LCT is a feasible experimental therapy in children.
- A structured monitoring protocol, particularly for portal vein pressure and flow, enhances the safety of pediatric LCT.
Abstract:
Despite recent advances and promising results in children, liver cell transplantation (LCT) should still be regarded as an experimental therapy. Several substantial complications are known from animal studies and individual patients. However, safety data on liver cell infusion in children are scarce. We used LCT in four children of different ages (3 weeks to 11 years, 3-40 kg) and underlying diseases [acute liver failure (n = 1), urea cycle disorders (n = 2), and Crigler-Najjar syndrome (n = 1)]. Vital parameters, portal vein flow (PVF), portal vein pressure (PVP), and liver enzymes were measured every 5 min during cell application and hourly thereafter between applications. An application protocol with discontinuation rules depending on changes in PVF and PVP was developed and successfully applied. Application was feasible in all children despite the catastrophic overall condition of the patient with acute liver failure. No application-related changes in vital parameters were found, and none of the children experienced clinical signs of portal vein thrombosis, pulmonary embolism, or anaphylactic reactions. Time courses for changes in PVF, PVP, and liver enzymes were obtained. Thorough monitoring of portal vein pressure and duplex sonography according to a defined protocol is likely to increase safety of cell application in pediatric LCT.
