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. 2019 May 15;101(10):904-911.
doi: 10.2106/JBJS.18.00915.

International Expert Consensus on a Cell Therapy Communication Tool: DOSES

Iain R Murray  1 , Jorge Chahla  2 , Marc R Safran  3 , Aaron J Krych  4 , Daniel B F Saris  4 , Arnold I Caplan  5 , Robert F LaPrade  6 ; Cell Therapies Communication Expert Group
Collaborators, Affiliations

International Expert Consensus on a Cell Therapy Communication Tool: DOSES

Iain R Murray et al. J Bone Joint Surg Am. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Clinical relevance: 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.

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Figures

Fig. 1
Fig. 1
Figs. 1-A and 1-B Bone marrow is harvested from sites such as the iliac crest. In orthopaedics, bone marrow is often concentrated by centrifugation prior to injection into joints, tissue, or the blood system. The popularity of “stem cell”-containing products, such as bone marrow aspirate concentrate, has been driven by ease of use and direct-to-consumer marketing.
Fig. 2
Fig. 2
Flowchart showing the consensus process.
Fig. 3
Fig. 3
Stacked leaning bar chart representing breakdown of agreement levels in the third-round Delphi survey.
Fig. 4
Fig. 4
Summary of the “DOSES” cell-therapy communication tool.
See this image and copyright information in PMC

Comment in

References

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