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Wiener-Kronish, Jeanine

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Wiener-Kronish

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Jeanine

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Wiener-Kronish, Jeanine
Author's Publications: search.filters.isAuthorOfPublication.4449ef2d-9237-45da-a521-3dbfeaf4dcf8Subject: search.filters.subject.Pulmonary edema

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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

    (Springer, 2014) Liu, Kathleen D; Wilson, Jennifer G; Zhuo, Hanjing; Caballero, Lizette; McMillan, Melanie L; Fang, Xiaohui; Cosgrove, Katherine; Calfee, Carolyn S; Lee, Jae-Woo; Kangelaris, Kirsten N; Gotts, Jeffrey E; Rogers, Angela J; Levitt, Joseph E; Wiener-Kronish, Jeanine; Delucchi, Kevin L; Leavitt, Andrew D; McKenna, David H; Thompson, B Taylor; Matthay, Michael A

    Background: Despite 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. Methods: This 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). Results: This 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. Conclusions: Experience 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 registration Clinical Trials Registration: NCT01775774 and NCT02097641.