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Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study

  • Benjamin M Davies
  • , Sarah Rikabi
  • , Anna French
  • , Rafael Pinedo-Villanueva
  • , Mark E Morrey
  • , Karolina Wartolowska
  • , Andrew Judge
  • , Robert E MacLaren
  • , Anthony Mathur
  • , David J Williams
  • , Ivan Wall
  • , Martin Birchall
  • , Brock Reeve
  • , Anthony Atala
  • , Richard W Barker
  • , Zhanfeng Cui
  • , Dominic Furniss
  • , Kim Bure
  • , Evan Y Snyder
  • , Jeffrey M Karp
    • Andrew Price, Andrew Carr, David A Brindley
  • 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.
  • 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.
  • Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.
  • University of Oxford
  • 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.
  • Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering; Loughborough University; Loughborough LE11 3TU United Kingdom
  • The Ear Institute, University College London, London, UK.
  • Harvard Stem Cell Institute, Cambridge, Massachusetts; Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA; Department of Stem Cell and Regenerative Biology, Harvard University, Cambridge, Massachusetts, USA;
  • Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
  • Oxford Centre for Tissue Engineering and Bioprocessing, University of Oxford, Oxford, UK.
  • Sartorius Stedim, Göttingen, Germany.
  • Sanford-Burnham Medical Research Institute, La Jolla, California, USA; Department of Pediatrics, School of Medicine, University of California, San Diego, La Jolla, California, USA; Sanford Consortium for Regenerative Medicine, La Jolla, California, USA; [email protected] [email protected] [email protected].
  • Harvard Stem Cell Institute, Cambridge, Massachusetts; Harvard-MIT Division of Health Sciences and Technology, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA; Center for Regenerative Therapeutics and Department of Medicine, Division of Biomedical Engineering, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA;
  • 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.
  • 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, MA, USA ; Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, UK.

Research output: Contribution to journal › Review article › peer-review

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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.

Original languageEnglish
JournalJournal of Tissue Engineering
Volume5
DOIs
Publication statusPublished - 22 Sept 2014

Bibliographical note

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (http://www.uk.sagepub.com/aboutus/openaccess.htm).

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