Title {1}	Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST): A structured study protocol for an open label dose escalation phase 1 trial followed by a randomised, triple-blind, allocation concealed, placebo controlled trial.
Trial registration {2a and 2b}.	ClinicalTrials.gov NCT03042143. Registered February 3rd 2017, https://clinicaltrials.gov/ct2/show/NCT03042143 EudraCT Number 2017-000584-33
Protocol version {3}	6.0 30.09.20
Funding {4}	Wellcome Trust Health Innovation Challenge Fund [Reference 106939/Z/15/Z] Research and Development Division of the Public Health AgencyNorthern Ireland
Author details {5a}	EG Clinical Research Fellow, Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University, Belfast MSH NIHR Clinician Scientist, Professor and Consultant in ICM, Guy’s and St Thomas’ NHS Foundation Trust London, School of Immunology and Microbial Sciences, King’s College London, and Centre for Inflammation Research, The University of Edinburgh, Edinburgh PH Research and Development lead in Critical Care, Kings Trauma Centre, King’s College London WST Consultant in Respiratory and Critical Care Medicine, Queen Elizabeth Hospital, Birmingham GDP Professor of Critical Care Medicine, University of Warwick and University Hospitals Birmingham JS Consultant in Critical Care, Belfast Health and Social Care Trust and Clinical Senior Lecturer, Wellcome-Wolfson Institute for Experimental Medicine PMCG Consultant in Intensive Care Medicine, Belfast Health and Social Care Trust CJ Clinical Trials Manager, Northern Ireland Clinical Trials Unit RB Clinical Trials Manager, Northern Ireland Clinical Trials Unit JMCF Trial Co-ordinator, Northern Ireland Clinical Trials Unit CMCD Head of Statistics, Northern Ireland Clinical Trials Unit CC Senior Biostatistician, Northern Ireland Clinical Trials Unit MMCF Lead Clinical Trials Pharmacist, Belfast Health and Social Care Trust JS Head of Cellular and Molecular Therapies, NHS Blood and Transplant Service JT Lead Translational Therapy Scientist, NHS Blood and Transplant Service BW Independent Patient and Public Representative GC Professor of Anaesthetics and Critical Care Medicine, Royal College of Surgeons in Ireland JL Professor of Anaesthesia and Critical Care Medicine, National University of Ireland, Galway MC Professor/Director of Northern Ireland Methodology Hub, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University, Belfast and Director Northern Ireland Clinical Trials Unit DFM Professor of Critical Care Medicine, Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University, Belfast COK Professor of Respiratory Medicine, Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University, Belfast
Name and contact information for the trial sponsor {5b}	Belfast Health and Social Care Trust (BHSCT) The Royal Hospitals Grosvenor Road Belfast BT12 6BA Northern Ireland
Role of sponsor {5c}	The Belfast Health and Social Care Trust (BHSCT) will act as Sponsor for the trial and the Chief investigator will take overall responsibility for the conduct of the trial. The funders have no role in the study design, data acquisition, data analysis or manuscript preparation.