The d-LIVER project originates from clinical needs and applies a scenario driven development methodology in response to European Commission FP7 ICT Objective ICT-2011.5.1: Personal Health Systems. This emphasizes research that aims for disease management and also targets rehabilitation and treatment at the point of need with a focus on specific diseases and in particular the requirement to address the need for ICT‑enabled artificial liver systems to facilitate detoxification as remote transient therapy at the point of need, offering continuous care from hospital to home settings, as stated in Target Outcome a3) Liver Failure.
There is a clear, unmet need for an ICT-enabled bio-artificial liver (BAL) in combination with liver patient management and support systems with associated monitoring and control for the remote management of patients with chronic liver disease outside the hospital. The overall goal of the project is to provide safe and cost-effective systems for continuous, context-aware, multi-parametric monitoring of both patient and BAL system parameters in order to: enhance the quality of medical treatment and management; improve the quality of life for patients; reduce the incidence and duration of hospitalization and consequently reduce the health economic burden of chronic liver disease. d-LIVER will facilitate improved treatment whilst enabling patients to spend more time at home under constant, albeit remote, medical supervision.
The vision and mission of the d-LIVER concept is shown in the figure. Central to this mission is the pursuit of more efficient bio-artificial liver support devices, with significant detoxification capability and synthetic metabolic activity, as well as high biocompatibility and safety. These systems will be capable of constantly communicating the status of both the patient and the BAL remotely to central clinical services, in a secure and confidential manner, such that patient monitoring is continuous and intervention can be both swift and beneficial.
The specific objectives of d-LIVER are to:
- Define the clinical requirements for patient management and bio-artificial liver unit operation in the chosen clinical scenarios (Month 7)
- Develop wearable sensing technologies for remote continuous monitoring of patient physical status (Month 32)
- Develop biochemical sensor technologies for accurate analytical measurements of patient blood biochemistry and bio-artificial liver unit quality parameters (Month 32)
- Produce model bio-artificial liver unit based on primary human or porcine hepatocytes integrated with multi-parametric sensor systems and closed loop control (Month 36)
- Develop instrumentation hardware platforms (Month 36)
- Develop Liver Patient Management System (LPMS) and integrate with hardware platform (Month 40)
- Clinically evaluate d-LIVER system for use at Point-of-Need in a clinical environment according to the defined scenarios (Month 42)
- Develop and evaluate clinically high risk bio-artificial liver technology (Month 42)
- Encompass innovation management ensuring exploitation of the developed technology (Month 48)
- Promote wide sectoral and geographical dissemination of the project results (Continuous)
- Integrate multidisciplinary education, training and skills development with research activities (Continuous)