Cartilage repair by autologous chondrocyte transplantation (ACTIVE)

Lead Research Organisation: Keele University
Department Name: Inst for Science and Tech in Medicine

Abstract

Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.

Technical Summary

Injury to the articular surfaces of the knee can lead to decreased physical activity, a poorer quality of life and impaired employment prospects. Cartilage has limited capacity for self-repair and chondral damage may predispose to osteoarthritis in later life, eventually necessitating knee replacement. Currently there is no uniform approach to managing these injuries and a number of different treatments are used with varying success.
Autologous chondrocyte transplantation (ACT) is a procedure in which the defect is repaired with cells prepared from the patient?s own cartilage. ACT was first used in Sweden and follow up of the patients over 9 years has revealed good or excellent results. Over 5000 patients have now been treated with ACT, mainly in the US and numerous observational studies have been reported. However conclusive evidence that ACT offers a better long-term outcome than the traditional procedures is lacking. The present proposal is for a multicentre (12 UK and 2 Norway) prospective randomised trial of ACT (conventional periosteal method or the more recently introduced collagen membrane variation) against traditional treatments (debridement, microfracture/drilling, mosaicplasty). The trial will be carried out with 660 patients, each with a chondral defect on the femoral condyl of the knee, and for whom a previous procedure has not relieved symptoms. Outcome will be assessed by validated functional knee scores (Lysholm, IKDC) and quality of life measures (SF36) at pre-set intervals over 10 years, by resource usage and days of work and by time to further surgical intervention.
 
Description ACTIVE Trial DATA used as part of HTA Vol 21 Issue 6 February 2017 - ACI in the knee:systemic review and economic evaluation AND also for NICE as a manufacturer as part of consultation for ID 686
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description NICE
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description NICE Meeting Regarding ChondroCelect TA89 [ID686] 11 June 2014
Geographic Reach National 
Policy Influence Type Membership of a guidance committee
 
Description NICE Multiple Technology Appraisal (MTA) Re ACI TA89 [ID686] 10 February 2015
Geographic Reach National 
Policy Influence Type Membership of a guidance committee
 
Description NICE Multiple Technology Appraisal re ACI TA89 [ID686] 14 April 2015
Geographic Reach National 
Policy Influence Type Membership of a guidance committee
 
Description NICE Scoping Consultation on ACI 6th August 2013
Geographic Reach National 
Policy Influence Type Participation in advisory committee
 
Description NICE Technology Assessment TA477 ACI for treating symptomatic articular cartilage defects of the knee
Geographic Reach National 
Policy Influence Type Participation in a national consultation
Impact Recognises ACI as a clinical and fundable treatment within the NHS and in turn will improve clinical service delivery.
URL http://nice.org.uk/guidance/ta477
 
Description ARUK Tissue Engineering Centre at the University of Keele/RJAH Orthopaedic Hospital, Oswestry
Amount £2,490,771 (GBP)
Funding ID 19429 
Organisation Versus Arthritis 
Start 02/2011 
End 04/2016
 
Description Arthritis Research UK Tissue Enginnering Centre II
Amount £1,900,000 (GBP)
Organisation Versus Arthritis 
Start 04/2016 
End 04/2021
 
Description Market Analysis of ACI in the UK and Abroad
Amount £10,000 (GBP)
Organisation Keele University 
Sector Academic/University
Country United Kingdom
Start 12/2018 
End 11/2019
 
Description Populations and Systems Medicine Board
Amount £604,000 (GBP)
Funding ID MR/L010453/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 11/2013 
End 10/2018
 
Description Programme Grant
Amount £480,000 (GBP)
Funding ID 18480 
Organisation Versus Arthritis 
Start 09/2009 
 
Title New Lysholm score 
Description New outcome score - first one for chondral defects 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2009 
Provided To Others? Yes  
Impact First score available 
 
Description ARUK Tissue Engineering Centre 
Organisation Newcastle University
Department Newcastle University Medical School
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-investigator in this collaboration and leading the clinical trials section.
Collaborator Contribution Obtaining MIA (IMP) for a CTA by the MHRA trial of autologous chondrocytes versus Mesenchymal Stem Cells
Impact Various presentations and publications
Start Year 2011
 
Description Arthritis Research UK Biomechanics and Bioengineering Centre Grant (University of Cardiff) 
Organisation Cardiff University
Country United Kingdom 
Sector Academic/University 
PI Contribution Professor Richardson invited to join the current Centre International Scientific Advisory Board as a research-oriented Orthopaedic Surgeon.
Collaborator Contribution Sharing of knowledge
Impact None
Start Year 2017
 
Description Collaboration with Dalian Medical University (China-UK Cartilage Trauma and Treatment Research Centre) 
Organisation Newcastle upon Tyne Hospitals NHS Foundation Trust
Department Orthopaedics
Country United Kingdom 
Sector Hospitals 
PI Contribution Lectures by Professor James Richardson (Cartilage repair and regeneration now and in the future) and Professor Sally Roberts (Challenges to cartilage regeneration) and a Workshop during visit to Dalian on 18th - 21st September 2015. Professor James Richardson and Professor Sally Roberts appointed as Visiting Professors of Dalian Medical University for a term of 3 years. To initially provide technical support and training with aim of establishing Centre. PhD Studentship has been funded by Keele University and Institute of Orthopaedics, Oswestry. Sudent appointed and commenced study in October 2017.
Collaborator Contribution PhD Student application PhD Student awarded grant for period of 3 years from Chinese Government towards Studentship in UK (2017 - 2020)
Impact Planned introduction of autologous cell therapy to Dalian in China. The first ACI procedure was performed in Dalian in October 2018.
Start Year 2015
 
Description Collaboration with Dalian Medical University (China-UK Cartilage Trauma and Treatment Research Centre) 
Organisation University of Oxford
Department Centre for Tissue Engineering and Bioprocessing
Country United Kingdom 
Sector Academic/University 
PI Contribution Lectures by Professor James Richardson (Cartilage repair and regeneration now and in the future) and Professor Sally Roberts (Challenges to cartilage regeneration) and a Workshop during visit to Dalian on 18th - 21st September 2015. Professor James Richardson and Professor Sally Roberts appointed as Visiting Professors of Dalian Medical University for a term of 3 years. To initially provide technical support and training with aim of establishing Centre. PhD Studentship has been funded by Keele University and Institute of Orthopaedics, Oswestry. Sudent appointed and commenced study in October 2017.
Collaborator Contribution PhD Student application PhD Student awarded grant for period of 3 years from Chinese Government towards Studentship in UK (2017 - 2020)
Impact Planned introduction of autologous cell therapy to Dalian in China. The first ACI procedure was performed in Dalian in October 2018.
Start Year 2015
 
Description External Expert Advisory Board Member - EU funded Phase II Clinical Study - Bio-Chip Project and clinical trial Nose to Knee II (Prof Richardson) 
Organisation University of Basel
Department Department of Biomedicine
Country Switzerland 
Sector Academic/University 
PI Contribution Professor Richardson is Member of the External Expert Advisory Board to give independent feedback and constructive comments. He attended their General Assembly in Dubrovnik in April 2017 and was also invited lecturer at 4th International Conference on Regenerative Orthopaedics which immediately followed the General Assembly meeting.
Collaborator Contribution N/A
Impact N/A
Start Year 2016
 
Description 11th Oswestry Cartilge Course 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Focussed Symposium on current techniques and regulatory requirements in cell cell therapy.
Year(s) Of Engagement Activity 2017
 
Description 12th ICRS 2015, Chicago May 2015 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation on ACTIVE "ACI in the knee -vs- alternatives. Latest results of randomised trial"
Year(s) Of Engagement Activity 2015
 
Description Annual Open Day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Lecture with slides and discussion

Raised interest
Year(s) Of Engagement Activity 2008
 
Description BORS 2015 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Lecture given by Professor Richardson summarising early results of ACTIVE and plans for ASCOT
Year(s) Of Engagement Activity 2015
 
Description Cell Therapy Workshop (Eurocell) Sept 2015 RJAH 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Focussed workshop on Autologous chondrocyte culture techniques and regulatory requirements.
Year(s) Of Engagement Activity 2015
 
Description International Cartilage Course 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation paper presentation
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact 8th Oswestry Cartilage Repair Meeting 2nd & 3rd May 2013 at RJAH Orthopaedic Hospital, Oswestry, Shropshire.
48 delegates
13 Trade Stands
26 Speakers (local, national and international)

9th Oswestry Cartilge Repair Meeting 2014 at RJAH Orthopaedic Hospital, Oswestry, Shropshire
54 Delegates
4 Companies
24 Speakers (local, national and international)



Discussion and updates on work being undertaken locally, nationally and internationally on tissue engineering. 9th Oswestry Cartilage Repair Meeting planned for 1st and 2nd May 2014.

Further meetings will be held and hope to run them every other year.
Year(s) Of Engagement Activity Pre-2006,2006,2009,2014
 
Description Invited Lecture by BORS for ICORS Congress, Xian 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Prof Richardson invited by UK BORS Chairman to be part of a workshop attending from the UK at ICORS Congress in Xian, China and a presenation on 'Cell therapy and tissue engineering for cartilage regeneration' was given. The invitation was following similar presentation which Prof Richardson gave at BORS meeting the previous year.
Year(s) Of Engagement Activity 2016
 
Description Poster AAOS, Las Vegas, March 2015 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Poster presentation on ACTIVE early results
Year(s) Of Engagement Activity 2015
 
Description Presentation (Prof Richardson) to AROS, Denmark 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Lecture and discussion by Professor Richardson on cell therapy for early arthritis "Personalising cell based treatments for cartilage repair"
Year(s) Of Engagement Activity 2015
 
Description Presentation (Prof Roberts) at AROS, Denmark 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Lecture and discussion by Professor Sally Roberts "Challenges of Cell Therapy for Intervertebral disc regeneration"
Year(s) Of Engagement Activity 2015
 
Description Presentation Audit Review (RJAH) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Presentation given by Prof James Richardson to colleagues and peers during multi disciplininary clinical audit meeting regarding Audit of ACI cases
Year(s) Of Engagement Activity 2016
 
Description Presentation at Outreach Evening at Keele University by Professor Richardson 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Professor Richardson invited to give presentation at Outreach Evening organised by Keele Univesity which was aimed at 6th Form Students and the general public.
Year(s) Of Engagement Activity 2017
 
Description Presentation by Dr Jan-Herman Kuiper at Keele University January 2019 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Presented at Seminar Debate: Regenerative Medicine - Changing the Paradigm of Treatment Outcomes - For the Many or the Few
Year(s) Of Engagement Activity 2019
 
Description Presentation by Dr Jan-Herman Kuiper at Keele University May 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Undergraduate students
Results and Impact Presented at Translating stem cell research into a new cell therapy for lung diseases to a mixed audience
Year(s) Of Engagement Activity 2018
 
Description Presentation by Mr Peter Gallacher (May 2018) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presentation to the National Orthopaedic Alliance to discuss the need for a Network of UK Accrediated Centres capable of ACI following NICE approval for the procedure.
Year(s) Of Engagement Activity 2018
 
Description Presentation by Prof James Richardson at Qatar Research Day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited to give presentation on cell therapy at Qatar Research Day 2017
Year(s) Of Engagement Activity 2017
 
Description Presentation by Prof Richardson and Prof Roberts (Basic Science Course, RJAH - Jan 2017) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Lecture given by Prof Richardson and Prof Roberts to delegates attending Basic Science Course 9th Januaury 2017 'Cartilage structure and function'
Year(s) Of Engagement Activity 2017
 
Description Presentation by Professor Sally Roberts (December 2018) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation entitled 'Medical Need for Autologous Implantation in the UK' at a User Experience Meeting for Spherox
Year(s) Of Engagement Activity 2018
 
Description Presentation to Local Polymyalgia Rheumatica Giant Cell Arteritis Group, Leebotwood, by Prof Sally Roberts and Dr Helen McCarthy 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other audiences
Results and Impact Invited by the Group Chairperson to give a talk on cell therapy at one of their monthly Group meetings
Year(s) Of Engagement Activity 2017
 
Description RJAH Annual Research Open day 2010 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Updated public and hospital staff on the progress of the trial initially
Now in recent years it is an Annual Research Day rather than 'open day' and research presentations and posters are given by both clinical and scientific members of staff at this Trust

none
Year(s) Of Engagement Activity 2006,2010,2011,2012,2013
 
Description RJAH Research Public Open Day 2017 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Open Day prior to 2017 RJAH Research Day with tours of research departments, presentations and display of research posters. Sharing information about research studies within organisation to general public and staff.
Year(s) Of Engagement Activity 2017
 
Description Report in the Institute of Orthopaedics Annual report 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach Regional
Primary Audience Supporters
Results and Impact To update public on trial progress

none
Year(s) Of Engagement Activity 2010
 
Description Research Day 2013 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact posters and presentations during whole day detailing reserch projects being undertaken by scientists and clinicians at RJAH, Oswestry

discussion
Year(s) Of Engagement Activity 2013
 
Description Steering Committee for Medical Science Society at local secondary school 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact Professor Sally Roberts gives talks and sits on the Steering Committee for the Medical Science Society at local secondary school
Year(s) Of Engagement Activity 2015
 
Description Visit Leukerband Clinic, Switzerland 19th & 20th January 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Prof Richardson was invited by Leukerband Clinic, Switzerland, to give two presentations relating to cell therapy research and clinical application for practitioners within their locality.
Year(s) Of Engagement Activity 2017