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Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.
Davies, Benjamin M; Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A.
Afiliação
  • Davies BM; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • Rikabi S; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • French A; The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK.
  • Pinedo-Villanueva R; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK ; MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, UK.
  • Morrey ME; Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.
  • Wartolowska K; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • Judge A; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK ; MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, UK.
  • MacLaren RE; Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford, UK.
  • Mathur A; NIHR Cardiovascular Biomedical Research Unit, London Chest Hospital, London, UK ; Department of Cardiology, Barts Health NHS Trust, London, UK ; Department of Clinical Pharmacology, William Harvey Research Institute, Queen Mary University of London, London, UK.
  • Williams DJ; Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University, Loughborough, UK.
  • Wall I; Department of Biochemical Engineering, University College London, London, UK ; Department of Nanobiomedical Science & BK21 Plus NBM Global Research Center for Regenerative Medicine, Dankook University, Cheonan, Republic of Korea ; Biomaterials and Tissue Engineering Lab, Department of Nanobiomed
  • Birchall M; The Ear Institute, University College London, London, UK.
  • Reeve B; Harvard Stem Cell Institute, Cambridge, MA, USA.
  • Atala A; Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
  • Barker RW; The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK.
  • Cui Z; Oxford Centre for Tissue Engineering and Bioprocessing, University of Oxford, Oxford, UK.
  • Furniss D; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • Bure K; Sartorius Stedim, Göttingen, Germany.
  • Snyder EY; Sanford-Burnham Medical Research Institute, La Jolla, CA, USA ; Department of Pediatrics, University of California, San Diego, La Jolla, CA, USA ; Sanford Consortium for Regenerative Medicine, La Jolla, CA, USA.
  • Karp JM; Harvard Stem Cell Institute, Cambridge, MA, USA ; Division of Biomedical Engineering, Department of Medicine, Center for Regenerative Therapeutics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA ; Harvard-MIT Division of Health Sciences and Technology, Massachusetts Institute
  • Price A; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • Carr A; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK ; The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK.
  • Brindley DA; Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK ; The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK ; Harvard Stem Cell Institute, Cambridge, M
J Tissue Eng ; 5: 2041731414551764, 2014.
Article em En | MEDLINE | ID: mdl-25383173
ABSTRACT
There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.
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Texto completo: 1 Temas: ECOS / Aspectos_gerais Bases de dados: MEDLINE Idioma: En Revista: J Tissue Eng Ano de publicação: 2014 Tipo de documento: Article País de afiliação: Reino Unido
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Temas: ECOS / Aspectos_gerais Bases de dados: MEDLINE Idioma: En Revista: J Tissue Eng Ano de publicação: 2014 Tipo de documento: Article País de afiliação: Reino Unido