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Videregen Limited (VID)

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Role:
Lead Organisation (Coordinator)

Videregen is a clinical-stage regenerative medicine company using its proprietary stem cell-based technology platform to develop a range of personalised, non-immunogenic organ replacement products for orphan indications. Its lead programme is a tissue engineered trachea replacement, and its patented technology and know-how is also being applied to the development of other organ replacement products, including mucosal lining, small bowel and liver replacements. The platform technology, which uses decellularised organ scaffolds seeded with the patient’s own cells to create new organs, has the potential to generate cost-effective and curative therapies for a range of devastating diseases. Founded in 2011, Videregen is an SME based in Liverpool, UK.

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NHS Blood and Transplant (NHSBT)

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Role:
Tissue Decellularisation and Shipping

NHS Blood and Transplant (NHSBT) is a Special Health Authority, dedicated to saving and improving lives through the wide range of services we provide to the NHS. Our ambition is to be the best organisation of our type in the world.

NHSBT Tissue & Eye Services operate the UK's largest tissue bank and are the largest not-for-profit organisation supplying the NHS with human tissue. We collect tissue from around 5000 living and deceased donors each year and provide around 12,500 implants per year that help save and improve the lives of 5,000 patients.

NHSBT Tissue & Eye Services is an expert in the field of decellularisation; dCELL human dermis is already available to surgeons in the UK for treatment of chronic leg ulcers, rotator cuff augmentation etc. NHSBT Tissue and Eye Services collaborates with major universities in the UK, including University College London and Universities of Leeds, Manchester, Newcastle, York, Bristol, Glasgow and Liverpool to implement a programme of decellularisation of a range of human tissues. NHSBT Tissue and Eye Services and its academic colleagues have received research funding from the EU and UK research councils and local and national charities.

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The University of Manchester (UNIMAN)

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Role:
Project Management for Partner 13 (UHSM)

The University of Manchester is one of the world’s top 50 universities. Research is at the heart of the University, no fewer than 20 former staff and students have gone on to be Nobel laureates and the university currently has 4 Nobel laureates as members of the academic staff. The University has over 1,800 staff active in research and over £190m of funding for research earned each year. Dr Niven is based within the Institute of Inflammation and Repair in the Faculty of Medical and Human Sciences.

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University Hospital of South Manchester (UHSM)

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The NIHR Respiratory and Allergy Clinical Research Facility (RACRF) is a research facility set up with funding from the NIHR to facilitate both translational and experimental research.

We are a specialist respiratory research team managed by Operational Lead Lesley Howard and Director Professor Jacky Smith.

The RACRF supports a wide range of respiratory and allergy research in key disease areas such as Chronic Cough, Food Allergy, Fungal Disease and COPD throughout the University Hospital of South Manchester (UHSM) and The University of Manchester. The unit also supports research within severe asthma, critical care and infectious diseases, cystic fibrosis and Interstitial Lung Disease and has a dedicated and highly trained team of clinicians, research nurses, clinical research physiologists and project management team to facilitate the delivery of multiple clinical trials. The RACRF’s core is located over two floors in the North West Lung Research Centre at UHSM. The RACRF also works closely with the UHSM R&D (Research & Development) directorate.

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University College London (UCL)

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Role:
Originator of Underpinning Technology

Professor Birchall is a Surgeon specialising in the management of disorders of the head and neck, voice and swallowing. Martin, with co-workers at UCL and overseas, developed decellularised biologic airway scaffolds combined with autologous cells and stem cells (either differentiated or undifferentiated), culminating in the world’s first stem cell based organ transplant in an adult (Lancet, 2008, 2014) and in a child (Lancet, 2012). In October, 2010, Martin performed the world’s first combined laryngeal and tracheal transplant with surgeons at the University of California Davis in a Californian woman who is now talking well. He was named Daily Telegraph-Morgan Stanley Briton of the Year for Science and Technology in 2009 and is the first ENT surgeon to be elected to the Academy of Medical Sciences (2011) and the first to be elected NIHR Senior Investigator (2014) and to serve on the UK's REF exercise. He runs a large multi-million pound transatlantic research programme funded by MRC, CIRM, TSB and NIHR, dedicated to the development of tissue-engineered organ replacements.

University College London Hospitals (UCLH)

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Role:
Clinical Site

A new hospital with state-of-the-art facilities using cutting edge technology, with spectacular views across London, University College Hospital is located on Euston Road, close to Warren Street and Euston Square Tube stations and is within walking distance of Euston railway station.

University College Hospital was officially opened by Her Majesty the Queen in October 2005. Services offered at University College Hospital include accident & emergency, hyper-acute stroke unit, cancer care, critical care, endocrinology, general surgery, ophthalmology, dermatology, general medicine, general neurology, rheumatology, orthopaedics, paediatric & adolescents, and urology. UCLH (with Charing Cross/Imperial College Healthcare) hosts UK’s complex airway team. This is a multidisciplinary group with pan London monthly meetings, including ENT, thoracic surgery, respiratory medicine, SLT, radiology, pathology and specialist nursing.

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Cell and Gene Therapy Catapult (CTC)

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Role:
Project Partner (Clinical and Regulatory Affairs)

The Cell and Gene Therapy Catapult was established in 2012 as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 100 employees focusing on cell and gene therapy technologies, we work with our partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. We offer leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. We aim to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. Regenerative medicine is one of the UK government’s “eight great technologies” that support UK science strengths and business capabilities. The Cell and Gene Therapy Catapult works with Innovate UK. For more information go to www.ct.catapult.org.uk or visit www.gov.uk/innovate-uk.

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TMC Pharma Services Limited (TMC)

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Role:
Regulatory and Clinical Trial Management

A unique pharmaceutical development organisation providing a full range of expert pharma/biotech support services. Our support activities can start with product manufacturing and pre-clinical testing, then run through full clinical trials and product development to obtaining global Marketing Authorisations. Post-approval our support continues with regulatory maintenance, pharmacovigilance, scientific service and much more.

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National Institute of Tuberculosis and Lung Diseases (IGICHP)

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Role:
Partner

IGICHP is a Poland-based pulmonary & respiratory research and clinical centre founded in 1877 in Warsaw. It has long-term experience in the research and implementation of new technologies and therapies with main focus on lung cancer, COPD, bronchial asthma and interstitial lung diseases. The Institute consists of 4 clinical and 7 diagnostic and research departments, and treats more than 11 000 inpatients and 30 000 outpatients annually. IGICHP is also the major teaching institution for respiratory medicine professionals in Poland. The Institute is the home for the national registries for lung cancer, alpha-1 antitrypsin deficiency and tuberculosis, as well as the lung cancer and multi-drug resistant Mycobacterium strains biobanks.

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TUM School of Medicine (TUM-MED)

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Role:
GMP Manufacture Site

Being dedicated to technical innovation, the University Hospital Klinikum rechts der Isar, the Technical University of Munich (TUM) and the Helmholtz Zentrum München have joined to establish TUMCells, a GMP Facility for Advanced Cellular Therapeutics, intended to serve as a translational platform for technical innovation and scientific competencies in Munich.

Its facility is designed for the manufacture, testing and release of somatic cell therapies, gene transfer medicinal products and tissue engineering products. TUMCells offers the complete range of GMP services such as project consultation and development, the provision of plant capacity on a contract basis and the production of ATMPs.

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University of Brescia (UNIBS)

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Role:
Patient Recruitment

The University of Brescia is a medium-size university, modern and productive like the region of Italy in which it is located. It offers quality programs and competitive research in areas related to Health, Law, Engineering and Economics.