CASE STUDIES

RegeniTherix™: a theranostic approach to overcoming wound healing barriers6th Nov 2013

Translation from laboratory to clinic

RegeniTherix™: a theranostic approach to overcoming wound healing barriers

Professor Shervanthi Homer-Vanniasinkam, Mr David Russell (Leeds Vascular Institute, Leeds General Infirmary) and Dr Mike Raxworthy (Neotherix)

 
 
Background

The i4i programme of the National Institute for Health Research (NIHR) has made a significant award to a consortium of clinicians and industry for work on a “theranostic” system to improve wound healing.

Work on this project is now progressing the development of a new wound management and diagnostic technology with the potential to improve healing times, provide time savings and cut costs. The RegeniTherix™ technology system comprises a material that both promotes wound healing and facilitates wound sampling, and an inexpensive reader device to measure wound biomarkers at the bedside.

The problem

As well as the pain, loss of sleep, reduced mobility and social isolation caused to patients, non-healing wounds place a significant burden on the NHS. An estimated 340,000 people in the UK suffer from chronic wounds at a cost of £4750 per patient, i.e. roughly 3% of the UK’s total healthcare expenditure. The consensus of various reviews of this problem is that the longer than necessary healing times frequently experienced result from a tendency to treat just the symptom (e.g. ulcer) and the lack of appropriate tools either to determine the underlying wound cause or complicating factors (e.g. infection or inflammation), or to guide the selection of treatment according to the stage of healing.

Project aims

The 2½ year project, which started in July 2012, aims to translate novel technology for managing non-healing (acute or chronic) wounds from the laboratory into clinical practice.

The objectives of the project are to (a) develop a series of biomarker-based wound assessment assays (SensaPharm, Complement Genomics and NPL) and (b) evaluate the utility of a novel electrospun scaffold-hydrogel system for obtaining real-time biological information on the healing status of problem, non-healing wounds (Neotherix and Leeds Vascular Institute). The regenerative scaffold-gel system is also designed to have a therapeutic, wound repair benefit as evidenced by earlier pre-clinical studies.

As well as permitting fast, sensitive and quantitative analysis, the technology has been designed to allow for the concurrent analysis of more than one biomarker. This is important because the relative amounts of wound biomarkers can be as significant as their individual concentrations. Building on successful laboratory proof-of-concept work funded by the Technology Strategy Board (TSB), the research will involve patients with non-healing diabetic foot ulcer wounds and be performed in the Limb Salvage Clinic run at St James’ University Hospital in Leeds. The research will enable the clinicians and industry researchers involved to produce an application demonstrator device (or kit of devices) ready for CE marking and clinical application, and in so doing take significant steps towards commercialisation.

The ability to identify biomarkers in near-real time in the immediate wound environment, together with the potential for rapid wound ‘characterisation’ will provide clinicians with unique insights into the healing status of the wound. This will allow a stratified approach to the selection of treatment choices and contribute to a substantial reduction in wasted expense incurred by the health system purchasing products to which particular patients will not respond. A 5% cost saving on NHS expenditure on chronic wounds is considered attainable and would have a value of £80m pa.
 

Hydrogel

Example of handheld biomarker reader

The team

The RegeniTherix™ consortium is led by the National Physical Laboratory (NPL) and includes the Leeds Vascular Institute at the General Infirmary at Leeds and the SMEs Neotherix (York), SensaPharm and Complement Genomics (both Sunderland).

 

For more information, contact the authors or the Chief Investigator, Alex Knight, at the National Physical Laboratory.

 

This report is independent research by the National Institute for Health Research Invention for Innovation (i4i) Programme, RegeniTherix™ - a novel theranostic technology to improve wound management, II-LS-0511-21008. The views expressed are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.
 

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