Project: Preclinical & clinical evaluation of FibroFix™: A mechanically advanced regenerative meniscal cartilage repair device.

Total knee replacement (TKR) procedures already cost the UK health service up to £1bn annually – more than total hip replacements(1). Based on population figures, this extrapolates to over €8bn annually in Europe, and is forecast to rise by as much as 525% by 2030 as a result of increasing obesity and age in the population(2). This epidemic of knee joint disease is neither economically sustainable nor clinically desirable. _x000D__x000D_TKR is required when deterioration of the cartilage in the knee joint results in osteoarthritis: a crippling condition which causes severe pain and loss of mobility. The menisci are tough, resilient pads of fibrous cartilage which act as the knee’s shock absorbers, providing the first line of defence against the damage that causes osteoarthritis. With their demanding mechanical function, the menisci are often damaged, resulting in pain and loss of mobility. Standard therapy is removal of the damaged tissue: partial meniscectomy. Despite the clear link with the subsequent onset of osteoarthritis and TKR, partial meniscectomy is the most common orthopaedic intervention(3,4) conducted in ~1.7m patients each year(5,6). Devices to restore meniscal function, and help prevent an unsustainable epidemic of TKR, are therefore urgently required._x000D__x000D_FibroFix™ is a tissue scaffold implant for repair of the meniscus following partial meniscectomy. Formed from the protein, silk fibroin, its molecular similarity to human fibronectin and highly porous architecture afford a tissue regenerative capability, while the smooth surface kinematics and molecular structure provide the strength, resilience and surface characteristics found in the human meniscus. This allows FibroFix™ to act as both a functional replacement for the tissue removed by meniscectomy and a long term regenerative repair. _x000D__x000D_Spidrex®, the Fibroin biomaterial technology underlying FibroFix™, was developed between 2005 and 2008 on the EU FP6 project “SILKBONE”. SILKBONE achieved ‘Excellent’ ratings and was the focus of a “Success Story” in the June 2010 edition of the EU SME Update magazine. FibroFix™ is featured in the forthcoming Special Edition of the Research*EU magazine and the SILKBONE project and FibroFix™ technology featured as part of the ‘Innovation Union’ launched by the Commission in September 2010 and in a EuroNews Television Channel feature titled ‘Innovation’ on February 4th 2011 commissioned by the DG Research. _x000D__x000D_To develop the outputs of the SILKBONE project, Orthox Ltd., the lead applicant of SILKMEN, was founded. In 2009, Orthox secured a £1.6m award from the UK biomedical foundation, The Wellcome Trust. Together with £675k from the UK government this has allowed Orthox to develop FibroFix™ to an advanced stage of preclinical validation. Orthox have a defined business plan for delivering FibroFix™ through clinical studies and onto the market. Recent, high level engagement with three EU based orthopaedic multinationals may also provide support for the commercialisation of FibroFix™. _x000D__x000D_In addition to Orthox, the consortium consists of the IORB, at the University of Ulm (IORB) and the BundeswehrKrankenHaus (BKH) at Ulm, Ps with whom Orthox has been actively collaborating since 2008. The IORB have expertise in biomechanical testing in advanced in vitro and in vivo models, whilst the BKH are experienced in orthopaedic clinical trials, with both key opinion leader surgeons and a high volume of patients presenting with meniscal injury._x000D_ _x000D_FibroFix™ is manufactured very affordably employing a robust, aseptic manufacturing process and has demonstrated exceptionally positive results from in vivo and in vitro evaluations carried out by P IORB. These results have witnessed letters of support for FibroFix™ from key opinion leaders in the orthopaedic surgical and industrial communities, as well as major corporates and ARC, a UK arthritis research foundation (Appendix pp6 - 7)._x000D__x000D_During year 1 the SILKMEN project aims to complete preclinical testing of FibroFix™ in both in vitro and in vivo models at the IORB whilst simultaneously implementing GMP manufacture at Orthox’s facilities and securing ISO13485 accreditation. Completion of these major project milestones will preface a pilot clinical study at the BKH in year 2 using FibroFix™ in 15 patients. The project endpoint will be a clinical report on 4 month follow up data from the 15 patients, together with submissions for a full scale CE mark clinical trial of FibroFix™. This will allow market launch of FibroFix™ within 18 months of the end of the project, providing surgeons with a clinical tool to help combat deterioration of the knee joint, and patients with the possibility of resuming a fully active lifestyle following meniscectomy._x000D__x000D_N.B. For all references cited see Appendix p9.

Acronym SILKMEN (Reference Number: 6896)
Duration 01/04/2012 - 31/03/2014
Project Topic FibroFix™ is a regenerative tissue scaffold which uniquely emulates the remarkable mechanical properties of spider silk. It is targeted at the clinical need for repair and regeneration of the meniscus in the knee. SILKMEN will deliver GMP manufacture and a human clinical study of FibroFix™.
Network Eurostars
Call Eurostars Cut-Off 7

Project partner

Number Name Role Country
3 Orthox Limited Coordinator United Kingdom
3 Department of Trauma and Orthopaedic Surgery, Centre of Muskuloskeletal Research, Armed Forces Hospital Ulm Partner Germany
3 Institute of Orthopaedic Research and Biomechanics, Centre of Musculoskeletal Research, University of Ulm Partner Germany