A Delphi study to establish a consensus definition and clinical reporting guidelines for Mesenchymal Stromal Cells

Abstract

ABSTRACTIntroductionDespite being more than two decades of research, Mesenchymal Stromal Cell (MSC) treatments are still struggling to cross the translational gap. Two key issues that likely contribute to these failures are i) the lack of clear definition for MSC and ii) poor quality of reporting in MSC clinical studies. To address these issues, we propose a modified Delphi study to establish a consensus definition for MSC and clinical reporting guidelines for MSC.Methods and analysisWe will conduct a three-round international modified Delphi Survey. Findings from a recent scoping review examining how MSC are defined and reported in preclinical and clinical studies were used to draft the initial survey for round one of our Delphi. Participants will include a ‘core group’ of individuals as well as researchers whose work was captured in our scoping review. The core group will include stakeholders from different research fields including developmental biology, translational science, research methods, regulatory practices, scholarly journal editing, and industry. The first two survey rounds will be online, and the final round will take place in person. Each participant will be asked to rate their agreement on potential MSC definition characteristics and reporting items using a Likert scale. After each round, we will analyse data to determine which items have reached consensus for inclusion/exclusion, and then develop a revised questionnaire for any new items, or items that did not reach consensus.Ethics and disseminationThis study received ethical approval from the Ottawa Health Research Network Research Ethics Board. To support the dissemination of our findings, we will use an evidence-based ‘integrated knowledge translation’ approach to engage knowledge users from the inception of the research. This will allow us to develop a tailored end-of-project knowledge translation plan to support and ensure dissemination and implementation of the Delphi results.Strengths and limitations of this studyWe proposed to address the current limitations in MSC experimental and clinical research with a rigorous and methodological consensus building method (Delphi method) that will allow for structured communication on controversial issues.To support dissemination and implementation of our results, we will engage stakeholders and end-users from the inception of the project – such as patient partners – and will develop a tailored end of project knowledge translation plan (integrated knowledge translation approach) in order to overcome historical issues related to community uptake.To address the main limitations of a Delphi method (e.g., lack of participation, no in-person interaction or information exchange), we use a modified Delphi survey with a Core group of stakeholders and a face-to-face meeting.