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Design and implementation of the START (STem cells for ARDS Treatment) trial, a phase 1/2 trial of human mesenchymal stem/stromal cells for the treatment of moderate-severe acute respiratory distress syndrome

Kathleen D. Liu,Jennifer G. Wilson,H. Zhuo,Lizette Caballero,Melanie McMillan,Xiaohui Fang,Katherine Cosgrove,C. Calfee,Jae-Woo Lee,K. Kangelaris,J. Gotts,A. Rogers,J. Levitt,J. Wiener‐Kronish,K. Delucchi,A. Leavitt,D. McKenna,T. Thompson,M. Matthay

Published 2014 in Annals of Intensive Care

ABSTRACT

BackgroundDespite advances in supportive care, moderate-severe acute respiratory distress syndrome (ARDS) is associated with high mortality rates, and novel therapies to treat this condition are needed. Compelling pre-clinical data from mouse, rat, sheep and ex vivo perfused human lung models support the use of human mesenchymal stem (stromal) cells (MSCs) as a novel intravenous therapy for the early treatment of ARDS.MethodsThis article describes the study design and challenges encountered during the implementation and phase 1 component of the START (STem cells for ARDS Treatment) trial, a phase 1/2 trial of bone marrow-derived human MSCs for moderate-severe ARDS. A trial enrolling 69 subjects is planned (9 subjects in phase 1, 60 subjects in phase 2 treated with MSCs or placebo in a 2:1 ratio).ResultsThis report describes study design features that are unique to a phase 1 trial in critically ill subjects and the specific challenges of implementation of a cell-based therapy trial in the ICU.ConclusionsExperience gained during the design and implementation of the START study will be useful to investigators planning future phase 1 clinical trials based in the ICU, as well as trials of cell-based therapy for other acute illnesses.Trial registrationClinical Trials Registration: NCT01775774 and NCT02097641.

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