Development of a novel, low cost ceramic monolithic extracorporeal adsorption device for the treatment of life-threatening inflammatory diseases

点击翻译按钮获取中文摘要

This project will develop a new technology and manufacturing process for a device aimed at the treatment of patients with life-threatening inflammatory conditions. The device is targeted at the treatment of a family of diseases in which the normally protective immune system attacks the tissues and organs of the body. These diseases include Sepsis and COVID-19\. A family of molecules, called cytokines, which control the immune system play a key role in these conditions. Removing these molecules has been shown to prevent the destruction of the tissues that often results in death. Sepsis is responsible for the majority of admissions to ITUs and has a cost to healthcare system of over £80billion globally. One of the most promising approaches to reducing the impact of the dangerous "cytokine storm" in these diseases is to remove the cytokines from the patient's circulation. This can be achieved by exposing the patient's circulation to materials that can adsorb these molecules, but currently technology designed to achieve are expensive, of limited uptake and are notoriously difficult and environmentally damaging to manufacture. Some years ago we developed a new membrane material which incorporated activated ceramic beads which studies showed to have genuine promise as a potential clinical cytokine adsorbent treatment. However, it was found to be impossible to mass manufacture safely and without environmental impact. The recent development of versatile 3D printing techniques opens up new avenues in this field and presents the possibility to produce new devices with the appropriate architecture using new materials that are associated with less carbon emissions and environmental pollution. These materials can be appropriately carbonised and activated in the same way as conventional polymer-based carbon beads without the associated manufacturing or environmental challenges. These new materials lend themselves to alternative manufacturing processes such as 3D printing. Building on our previous experience, we will define the manufacturing conditions to ensure that we produce appropriately activated ceramic structures that can be easily incorporated into a filter device to remove cytokines from the blood of patients. Such devices will be a fraction of the cost of current approaches and will lead to a democratisation of access to this valuable treatment. In this project, we will design and characterise the device and the manufacturing process with a view to future clinical deployment, producing a plan for their manufacture , future clinical and pre-clinical trials and regulatory approval strategy.