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J Tissue Eng. 2014 Sep 19;5:2041731414551764. doi: 10.1177/2041731414551764. eCollection 2014.

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

Author information

1
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
2
The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK.
3
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.
4
Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.
5
Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford, UK.
6
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.
7
Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University, Loughborough, UK.
8
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 Nanobiomedical Science and WCU Research Center, Dankook University, Cheonan, Republic of Korea.
9
The Ear Institute, University College London, London, UK.
10
Harvard Stem Cell Institute, Cambridge, MA, USA.
11
Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
12
Oxford Centre for Tissue Engineering and Bioprocessing, University of Oxford, Oxford, UK.
13
Sartorius Stedim, Göttingen, Germany.
14
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.
15
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 of Technology, Cambridge, MA, USA ; Harvard Medical School, Cambridge, MA, USA.
16
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.
17
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.

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.

KEYWORDS:

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

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