Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.
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.
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Benjamin M
BM
Davies
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Sarah
S
Rikabi
The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK.
Anna
A
French
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.
Rafael
R
Pinedo-Villanueva
Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.
Mark E
ME
Morrey
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Karolina
K
Wartolowska
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.
Andrew
A
Judge
Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford, UK.
Robert E
RE
MacLaren
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.
Anthony
A
Mathur
Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University, Loughborough, UK.
David J
DJ
Williams
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.
Ivan
I
Wall
The Ear Institute, University College London, London, UK.
Martin
M
Birchall
Harvard Stem Cell Institute, Cambridge, MA, USA.
Brock
B
Reeve
Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Anthony
A
Atala
The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK.
Richard W
RW
Barker
Oxford Centre for Tissue Engineering and Bioprocessing, University of Oxford, Oxford, UK.
Zhanfeng
Z
Cui
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Dominic
D
Furniss
Sartorius Stedim, Göttingen, Germany.
Kim
K
Bure
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.
Evan Y
EY
Snyder
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.
Jeffrey M
JM
Karp
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Andrew
A
Price
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.
Andrew
A
Carr
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.
David A
DA
Brindley
Cell- and tissue-based therapy; regenerative medicine; stem cells; tissue engineering; translational medical research