The lack of a standardized system for describing cell therapies acts as a barrier to advancement in clinical and basic research and practice. The aim of this study was to establish an international expert consensus on strategies to improve standardization and transparency when describing cell therapies. The secondary aim was to develop a consensus among experts on the contents of a standardized tool for describing cell therapies.
The need for expert consensus on strategies to improve cell therapy communication was confirmed at the American Academy of Orthopaedic Surgeons/National Institutes of Health Optimizing Clinical Use of Biologics Symposium in 2018. A working group of 6 experts convened an international consensus process involving clinicians and basic scientists using validated Delphi methodology. This iterative process was used to define statements on communication of cell therapies and develop a standardized tool for describing cell therapies.
Thirty-four experts completed 3 rounds survey with use of the Delphi process. After 3 rounds, 27 statements relating to existing nomenclature, solutions to improve communication, ideal characteristics of a framework, mandatory elements of a new framework, and future work to facilitate application reached consensus with >80% agreement and <5% disagreement. Consensus was reached on the contents of a tool for improving standardization and transparency when describing cell therapies. This tool, dubbed “DOSES,” is based on the reporting of 5 core items: donor (i.e., autologous, allogeneic, xenogeneic), origin of tissue, separation from other cell types/preparation method, exhibited cell characteristics associated with behavior, and the site of delivery.
This study has established expert consensus on the communication of cell therapies. The DOSES tool has been developed to improve standardization and transparency in describing cell therapies.
The DOSES tool for describing cell therapies can be utilized by researchers, clinicians, regulators, and industry professionals to improve standardization and transparency when describing cell therapies. The use of this tool may allow clinicians and patients to better understand the characteristics of current and future cell preparations.
1Department of Orthopaedic Surgery, The University of Edinburgh, Edinburgh, United Kingdom
2Rush University Medical Center, Chicago, Illinois
3Department of Orthopaedic Surgery, Stanford University School of Medicine, Redwood City, California
4Department of Orthopedic Surgery and Sports Medicine, Mayo Clinic, Rochester, Minnesota
5Skeletal Research Center, Biology Department, Case Western Reserve University, Cleveland, Ohio
6The Steadman Clinic, Vail, Colorado
E-mail address for R.F. LaPrade: firstname.lastname@example.org
*Arnold I. Caplan, PhD, Brian J. Cole, MD, MBA, Farshid Guilak, PhD, Scott A. Rodeo, MD, Christian Lattermann, MD, Mark A. Birch, PhD, Bruno Peault, PhD, Leela C. Biant, BSc(Hons), MBBS, AFRCSEd, FRCSEd(Tr&Orth), MSres, MFSTEd, Jorge Chahla, MD, PhD, Constance R. Chu, MD, Matthew J. Dalby, PhD, Allan B. Dietz, PhD, Jason L. Dragoo, MD, Lars Engebretsen, MD, PhD, Denis Evseenko, PhD, Alan Getgood, MD, FRCS(Tr&Orth), DipSEM, Andrew G. Geeslin, MD, Anthony P. Hollander, PhD, Johnny Huard, PhD, Elizaveta Kon, MD, Aaron J. Krych, MD, Robert F. LaPrade, MD, PhD, Nicola Maffulli, MD, MS, PhD, FRCS, FRCS(Orth), FFSEM, Bert R. Mandelbaum, MD, Rodrigo Mardones, MD, Iain R. Murray, BMedSci(Hons), MRCS, MFSEM, PhD, Frank A. Petrigliano, MD, Marc R. Safran, MD, Daniel B.F. Saris, MD, PhD, A. Hamish R.W. Simpson, MA(Cantab), FRCS(Tr&Orth), DM(Oxon), James H.C. Wang, PhD, Henning Madry, MD, Chris H. Jo, MD, PhD, and Norimasa Nakamura, MD, PhD
A commentary by Scott A. Rodeo, MD, is linked to the online version of this article at jbjs.org.
Disclosure: The authors indicated that no external funding was received for any aspect of this work. On the Disclosure of Potential Conflicts of Interest forms, which are provided with the online version of the article, one or more of the authors checked “yes” to indicate that the author had a relevant financial relationship in the biomedical arena outside the submitted work and “yes” to indicate that the author had other relationships or activities that could be perceived to influence, or have the potential to influence, what was written in this work (http://links.lww.com/JBJS/F181).