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J Tissue Eng. 2017 Aug 11;8:2041731417724413. doi: 10.1177/2041731417724413. eCollection 2017 Jan-Dec.

A quantitative, multi-national and multi-stakeholder assessment of barriers to the adoption of cell therapies.

Author information

1
Division of Trauma and Orthopaedic Surgery, Department of Surgery, University of Cambridge, Cambridge, UK.
2
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
3
The UCL-Oxford Centre for the Advancement of Sustainable Medical Innovation, University of Oxford, Oxford, UK.
4
Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.
5
Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford, UK.
6
Centre for Biological Engineering, The Wolfson School of Mechanical, Electrical and Manufacturing Engineering, Loughborough University, Loughborough, UK.
7
Sartorius Stedim, Göttingen, Germany.
8
MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.
9
NIHR Cardiovascular Biomedical Research Unit, London Chest Hospital, London, UK.
10
Department of Cardiology, Barts Health NHS Trust, London, UK.
11
Royal National Throat, Nose, and Ear Hospital, University College London, London, UK.
12
Sanford Burnham Prebys Medical Discovery Institute, San Diego, CA, USA.
13
Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA.
14
Harvard Stem Cell Institute, Cambridge, MA, USA.
15
Department of Paediatrics, University of Oxford, Oxford, UK.
16
Saïd Business School, University of Oxford, Oxford, UK.
17
Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, UK.

Abstract

Cellular therapies, such as stem cell-based treatments, have been widely researched and numerous products and treatments have been developed. Despite this, there has been relatively limited use of these technologies in the healthcare sector. This study sought to investigate the perceived barriers to this more widespread adoption. An anonymous online questionnaire was developed, based on the findings of a pilot study. This was distributed to an audience of clinicians, researchers and commercial experts in 13 countries. The results were analysed for all respondents, and also sub-grouped by geographical region, and by profession of respondents. The results of the study showed that the most significant barrier was manufacturing, with other factors such as efficacy, regulation and cost-effectiveness being identified by the different groups. This study further demonstrates the need for these important issues to be addressed during the development of cellular therapies to enable more widespread adoption of these treatments.

KEYWORDS:

Cell- and tissue-based therapy; clinical adoption; regenerative medicine; stem cells; translational medical research

Conflict of interest statement

Declaration of conflicting interests: M.B. is a consultant to Reneuron and Videregen. D.B. is a stockholder in Translation Ventures Ltd (Charlbury, Oxfordshire, UK) and IP Asset Ventures Ltd (Oxford, Oxfordshire, UK), companies that, among other services, provide cell therapy biomanufacturing, regulatory and financial advice to pharmaceutical clients. D.B. also is subject to the CFA Institute’s codes, standards and guidelines, so he must stress that this piece is provided for academic interest only and must not be construed in any way as an investment recommendation. Additionally, at the time of publication, D.B. and the organizations with which he is affiliated may or may not have agreed and/or pending funding commitments from the organizations named herein.

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