Functional Tissue Replacement and Substitution: Platform Grant

Lead Research Organisation: University of Leeds
Department Name: Mechanical Engineering

Abstract

Our research in functional tissue replacement and substitution addresses both major societal needs and global economic opportunities. It impacts upon a spectrum of medical interventions from functional biomaterials and devices to tissue engineered constructs. It primarily focuses on degenerative deficiencies and ageing in the musculoskeletal and cardiovascular systems, by converging physical and biological sciences and technologies to address national and international opportunities. In particular it addresses the major societal needs of the functional ageing population, which has an increased retirement age, extended working life and increased longevity, by providing devices and therapeutic interventions to sustain mobility and relieve pain. Our research addresses increased patient expectation for earlier intervention, rapid rehabilitation, increased functional demand and personalized solutions.This will be delivered though research and development of devices and therapies that enable tissue preservation and regenerative capacity and more rapid restoration of natural biomechanical function. It will apply recent advances in biological sciences and nanoscale technologies, integrating this multidisciplinary science through a systems engineering approach to new technology discovery and product innovation.The program of research will build upon our previous research in wear of joint replacements in the hip and knee, in which we have researched and developed new materials and designs to provide longer lasting joints for young and active patients. It will address new approaches to partial joint replacement, cartilage substitution and tissue engineering, which have the potential to provide earlier intervention, tissue sparing and minimally invasive surgical therapies. It will also address functional tissue substitution in the spine, through bone preserving and augmentation therapies and new articulating implants and disc replacements. Particularly important in the spine is the development of functional simulation systems to replicate in the laboratory and in computer models the complex structure and function found in vivo. In the cardiovascular system novel biomimetic tissue scaffolds, which provide functional tissue regeneration solutions for blood vessels and heart valves, will be researched, through laboratory and clinical models.

Publications

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Abdelgaied A (2014) The effect of insert conformity and material on total knee replacement wear. in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine

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Abdelgaied A (2013) Quantification of the effect of cross-shear and applied nominal contact pressure on the wear of moderately cross-linked polyethylene. in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine

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Al-Hajjar M (2013) Effect of femoral head size on the wear of metal on metal bearings in total hip replacements under adverse edge-loading conditions. in Journal of biomedical materials research. Part B, Applied biomaterials

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Al-Hajjar M (2013) Wear of novel ceramic-on-ceramic bearings under adverse and clinically relevant hip simulator conditions. in Journal of biomedical materials research. Part B, Applied biomaterials

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Al-Hajjar M (2013) Wear of 36-mm BIOLOX(R) delta ceramic-on-ceramic bearing in total hip replacements under edge loading conditions. in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine

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Brockett C (2012) Wear of knee prostheses in Orthopedic Research and Reviews

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Brockett C (2011) Assessment of Squeaking in Total Hip Replacements in Seminars in Arthroplasty

 
Description Defintion of a new wear law for polyethylene in knee replacements

Defintion of a novel computational model to predict wear of polyethylene in the knee replacement

Experimental validation of knee wearprdictions ina fullknee joint simulation

Defintion of low wear and low conforming polyethylene knee designs

Development of improved knee joint simulation methods and simulation sytems.



Development of advanced simulation systems to predict wear in hip joints undr a wider set of operating conditions.

First demonstrations of effect of variation in surgical positioning on the microseparation , edge loading and wear of hip joints.

Defintion of combined effect of variation in rotational position and translational positioning on edge loading and wear of hip joint prostheses.

Development of improved hip joint simulation methods and simulation sytems



Development of processes for manufacture of acellular scaffolds for vascular and cardiovascular tissues, including vascualr patches, vascular grafts and heart valves. Characterisation and evaluation of the acellular scaffolds, progression to in vivo evaluations
Exploitation Route Developemnt of new hip and knee joint simulation sytems by Simulation Solutions

Development of lower wearing joint replacements, through collaborations with industry partners, DePuy and Mathys

Development of acellular scaffolds by NHS Blood and Transplant

Development of acellular scaffolds by University spin out Tissue Regenix Collaborative research to develop lower wearing and longer lasting joint replacements

Development of improved pre- clincial joint simulation and testing systems

Development of acellular scaffolds for tissue repair derived from human tissue for tissue transplantation and from animal tissues as medical devices
Sectors Healthcare

URL http://imbe.leeds.ac.uk
 
Description Natural knee simulation system has been designed , manufactured and sold by industry partner Simulation Solutions. Patent on acellular bone tendon bone, transferred to NS BT for manufacture of acellular human tissue grafts
First Year Of Impact 2014
Sector Healthcare
Impact Types Societal,Economic

 
Description international standards committee chair
Geographic Reach Asia 
Policy Influence Type Membership of a guideline committee
Impact international pre clinical testing standards
 
Description Biocomposites
Amount £200,000 (GBP)
Funding ID LMJ 
Organisation Biocomposites 
Sector Private
Country United Kingdom
Start 01/2013 
End 01/2016
 
Description Biomedical research unit
Amount £6,000,000 (GBP)
Funding ID Leeds musculoskeletal biomedical research unit 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 04/2014 
End 03/2017
 
Description CDT 2014-22
Amount £4,000,000 (GBP)
Funding ID CDT TERM 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 06/2014 
End 09/2022
 
Description DTC 208-2017
Amount £7,000,000 (GBP)
Funding ID DTC 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 06/2008 
End 09/2017
 
Description DTP
Amount £2,000,000 (GBP)
Funding ID DTP 
Organisation DePuy Synthes 
Sector Private
Country United States
Start 01/2014 
End 01/2016
 
Description EPSRC cartilage programme
Amount £4,600,000 (GBP)
Funding ID EPG01121721 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 06/2009 
End 06/2015
 
Description Healthcare Impact Partnership
Amount £1,025,492 (GBP)
Funding ID EP/N02480X/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 06/2016 
End 05/2021
 
Description Healthcare Technologies Programme Grant
Amount £3,962,447 (GBP)
Funding ID EP/N02480X/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 10/2016 
End 09/2021
 
Description IKC
Amount £10,000,000 (GBP)
Funding ID "EP G0324831, EPI0191031, EPJ0176201" 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 04/2009 
End 04/2016
 
Description Medical engineering centre
Amount £4,200,000 (GBP)
Funding ID WELMEC 
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2014 
End 09/2015
 
Description NHSBT
Amount £200,000 (GBP)
Funding ID EI 
Organisation NHS Blood and Transplant (NHSBT) 
Sector Public
Country United Kingdom
Start 01/2014 
End 01/2017
 
Description Tissue regenix
Amount £60,000 (GBP)
Funding ID EI 
Organisation Tissue Regenix Ltd 
Sector Private
Country United Kingdom
Start 01/2016 
End 01/2018
 
Description invibio
Amount £400,000 (GBP)
Funding ID LMJ 
Organisation Invibio 
Sector Private
Country United Kingdom
Start 01/2014 
End 12/2016
 
Description mathys
Amount £400,000 (GBP)
Funding ID LMJ 
Organisation Mathys 
Sector Private
Country Switzerland
Start 01/2014 
End 01/2016
 
Title Biomechanical and biotribological simulation model natural hip 
Description Biomechanical and biotribological model of natural hip 
Type Of Material Computer model/algorithm 
Year Produced 2013 
Provided To Others? Yes  
Impact used in follow on research 
 
Title Biomechanical model of functional spinal unit 
Description model of functional spinal unit 
Type Of Material Computer model/algorithm 
Year Produced 2014 
Provided To Others? Yes  
Impact used in follow on research 
 
Title Biotribological model naturala knee 
Description Biotribological model natural knee 
Type Of Material Computer model/algorithm 
Year Produced 2014 
Provided To Others? Yes  
Impact Used in follow on research on regenerative devices 
 
Title wear simulation model artificial hip 
Description wear simulation model artificial hip 
Type Of Material Computer model/algorithm 
Year Produced 2010 
Provided To Others? Yes  
Impact applied in industry contract research 
 
Title wear simulation model artificial knee 
Description wear simulation model artificial knee 
Type Of Material Computer model/algorithm 
Year Produced 2012 
Provided To Others? Yes  
Impact used in industry contract research 
 
Description Biocomposites Ltd 
Organisation Biocomposites
Country United Kingdom 
Sector Private 
PI Contribution Calcium Phosphate Bone Void Filler - A Pin-on-Plate Study; Calcium Sulphate Bone Void Filler Comparison - A Pin-on-Plate Study
Collaborator Contribution participate in research and publication
Impact Publication
Start Year 2014
 
Description Corin 
Organisation Corin Group PLC
Country United Kingdom 
Sector Private 
PI Contribution Metal on metal hip wear
Collaborator Contribution materials
Impact multidiciplinary
Start Year 2009
 
Description DePuy 
Organisation Depuy International
Country United Kingdom 
Sector Private 
PI Contribution Thirty-three projects.
Collaborator Contribution funds , materilas staff
Impact publications
Start Year 2013
 
Description Depuy International Ltd 
Organisation Depuy International
Country United Kingdom 
Sector Private 
Start Year 2004
 
Description Invibio 
Organisation Invibio
Country United Kingdom 
Sector Private 
PI Contribution Four projects: PEEK low con knees; Investigation of biocompatibilty of PEEK wear debris; Investigation of PEEK as cervical disc bearing material; Low Cost Polymer Knee
Start Year 2010
 
Description JRI 
Organisation JRI Orthapaedics
Country United Kingdom 
Sector Private 
PI Contribution Ceramic composite hip wear
Start Year 2009
 
Description Mathys Medical 
Organisation Mathys
Country Switzerland 
Sector Private 
PI Contribution Four projects including: Evaluation of potential ceramic matrix hips Ceramic matrix composite hip Wear of Experimental Ceramics in Total Hip Replacement - A Hip Joint Simulator Study (Mathys IV) Wear of Experimental Ceramics in Total Hip Replacement - A Hip Joint Simulator Study (Mathys V)
Collaborator Contribution materials , research methods , analysis
Impact papres
Start Year 2013
 
Description NHS NBTS 
Organisation NHS Blood and Transplant (NHSBT)
Department National Blood Service
Country United Kingdom 
Sector Public 
PI Contribution 8 projects in collaboration with NHS NBTS Acellular bone ligament graft (Human) Acellular bone meniscus bone graft (Human) Acellular OC graft (Human) Allo vascular graft Allo heart valve Biocompatibility of acellular allogeanic dermis Acellular allogeneic aorta Development of dCELL bone-patella-bone allograft for anterior cruciate ligament replacement
Collaborator Contribution funds time
Impact multidiciplinary
Start Year 2010
 
Description National Blood Service 
Organisation NHS Blood and Transplant (NHSBT)
Department National Blood Service
Country United Kingdom 
Sector Public 
Start Year 2003
 
Description Proctor and Gamble 
Organisation Procter & Gamble
Country United States 
Sector Private 
PI Contribution Electronic Biomarker Detection (eTect)
Start Year 2010
 
Description Simulation Solutions 
Organisation Simulation Solutions
Country United Kingdom 
Sector Private 
PI Contribution 10 projects in collaboration with Simulation Solutions: High flex knee simulator Natural knee simulator Natural hip simulator Natural spine simulator Natural joint friction simulator knee joint simulator SOP for hip simulator SOP for knee simulator Natural Knee Simulation System Electro mechanical hip simulator method SOP and training
Collaborator Contribution equipment development
Impact publications
Start Year 2014
 
Description Surgical Innovations 
Organisation Surgical Innovations
Country United Kingdom 
Sector Private 
PI Contribution A total of 4 collaborations with Surgical Innovations A new Arthroscopic Port for use in Arthroscopic Surgery applications Arthroscopic Port Environment Test Cell Design improvements to existing laparoscopy scissors Intra-Abdominal Platform (IAP) development
Start Year 2010
 
Description Tissue Regenix 
Organisation Tissue Regenix Ltd
Country United Kingdom 
Sector Private 
PI Contribution A total of 12 projects collaborating with Tissue Regenix Acellular ligament graft (Animal) Acellular bone meniscus bone graft (Animal) Acellular OC graft (Animal) Xeno vascular patch Xeno heart valve Decellularised bladder Decellularised meniscus (see also 12b) Acellular porcine flexor tendon graft Development of the dCELL Partial Meniscus In vivo testing of dCell bone to determine osseointegration and biocompatibility In vivo evaluation of decellularised porcine pulmonary roots. Long Term Evaluation of an Acellular Bovine Arterial Graft in an Ovine Arteriovenous Access Model
Start Year 2009
 
Description Vascutec 
Organisation Vascutek Ltd
Country United Kingdom 
Sector Private 
PI Contribution Heart valve conduit
Start Year 2010
 
Title ISO accredited simulation test laboratory 
Description ISO accredited simulation test laboratory for pre clinical testing and trials widely used by customers around globe 
Type Support Tool - For Medical Intervention
Current Stage Of Development Wide-scale adoption
Year Development Stage Completed 2013
Development Status Under active development/distribution
Impact uptake by wide range of companies 
 
Title acellular bone 
Description under development and in in vivo trials 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Refinement. Non-clinical
Year Development Stage Completed 2014
Development Status Under active development/distribution
Impact under development and in animal trials 
 
Title acellular bone cartilage osteochondral graft 
Description under development 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Initial development
Year Development Stage Completed 2014
Development Status Under active development/distribution
Impact under developemnt 
 
Title acellular bone cartilage osteochondral graft 
Description under development NHSBT 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Initial development
Year Development Stage Completed 2015
Development Status Under active development/distribution
Impact under development 
 
Title acellular bone patellar bone graft 
Description under development by NHSBT 
Type Therapeutic Intervention - Surgery
Current Stage Of Development Refinement. Non-clinical
Year Development Stage Completed 2014
Development Status Under active development/distribution
Impact under development by NHSBT 
 
Title acellular dcell vascular patch 
Description licensed to and commercialised by Tissue Regenix 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2010
Development Status Under active development/distribution
Clinical Trial? Yes
Impact First dcell clinical product 
URL https://clinicaltrials.gov/show/NCT00958230
 
Title acellular dcell dermis 
Description commercialised by Tissue regenix from 2014 
Type Therapeutic Intervention - Medical Devices
Year Development Stage Completed 2014
Development Status Under active development/distribution
Impact sold and distributed in USA 
 
Title acellular dermis 
Description supplied as clinical product by NHSBT 
Type Therapeutic Intervention - Surgery
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2014
Development Status Under active development/distribution
Impact supplied by NHSBT, improved wound healing in chronic leg ulcers 
 
Title acellular heart valve 
Description clinical application through human tissue bank 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2010
Development Status Under active development/distribution
Impact proof of clinical use acellular technology 
 
Title acellular vascular graft 
Description under development by NHSBT and Tissue Regenix 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Refinement. Non-clinical
Year Development Stage Completed 2014
Development Status Under active development/distribution
Impact Under development by NHSBT an dTissue Regenix 
 
Title all polymer knee 
Description collaborative development with Invibio 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Initial development
Year Development Stage Completed 2015
Development Status Under active development/distribution
Impact collaborative development with Invibio 
 
Title ceramic on ceramic hip 
Description Mathys 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Market authorisation
Year Development Stage Completed 2012
Development Status Under active development/distribution
Impact successfully adopted an d commercilised 
 
Title ceramic on ceramic and ceramic on metal hip 
Description commercialised by DePuy and by Mathys 
Type Therapeutic Intervention - Medical Devices
Year Development Stage Completed 2015
Development Status Under active development/distribution
Impact successfully adopted an d commercilised 
 
Title dcell ligament 
Description Under commercial development by tissue Regenix, progressing to CE mark and product launch 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Refinement. Non-clinical
Year Development Stage Completed 2014
Development Status Under active development/distribution
Clinical Trial? Yes
Impact under commercial development by Tissue Regenix in clinical trial started 2015 proceeding to Ce mark and product launch 2017 
URL https://clinicaltrials.gov/show/NCT02540811
 
Title dcell meniscus 
Description Developed by tissue Regenix In clinical trial started 2015 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2014
Development Status Under active development/distribution
Clinical Trial? Yes
Impact first in man clinical trial started 2015 
URL https://clinicaltrials.gov/show/NCT02270905
 
Title finite element simulation tools to capture patient variation for the analysis of orthopaedic devices across a patient cohort 
Description This project has been led by Dr Ruth Wilcox in partnership with Simpleware Limited. The development of the software add-on has been completed and the final validations with the Leeds data set-set are coming to an end. It is anticipated that a technology demonstrator project will now be undertaken with a company that can demonstrate the utility of the software for evaluating spinal implants. The commercial team is now engaged and discussions with Simpleware around a possible license deal are on-going. It is envisaged that as part of this license deal Simpleware will engage Leeds expertise as part of their offer to companies. In addition Leeds personnel will retain the right to undertake consultancy in their own capacity. 
Type Of Technology Software 
Year Produced 2013 
Impact further research 
 
Title hip joint simulator 
Description hip joint simulator 
Type Of Technology Physical Model/Kit 
Year Produced 2012 
Impact commercial product Simulation solutions 
 
Title knee joint simulator 
Description knee joint simulator 
Type Of Technology Physical Model/Kit 
Year Produced 2013 
Impact Commercial product simulation solutions 
 
Title natural hip simulator 
Description natural hip simulator 
Type Of Technology Physical Model/Kit 
Year Produced 2014 
Impact commercial product simulation solutions 
 
Title natural knee simulator 
Description natural knee simulator 
Type Of Technology Physical Model/Kit 
Year Produced 2013 
Impact commercialised by simulation solutions 
 
Title spinal disc simulator 
Description spinal disc simulator 
Type Of Technology Physical Model/Kit 
Year Produced 2010 
Impact commercial product simulation solutions