دورية أكاديمية
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
| العنوان: | 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 |
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| المؤلفون: | 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 P, Delucchi, Kevin L, Leavitt, Andrew D, McKenna, David H, Thompson, B Taylor, Matthay, Michael A |
| بيانات النشر: | Springer |
| سنة النشر: | 2014 |
| المجموعة: | Harvard University: DASH - Digital Access to Scholarship at Harvard |
| مصطلحات موضوعية: | Acute lung injury, Clinical trial, Mesenchymal stem/stromal cell, Pulmonary edema |
| الوصف: | 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. ; Version of Record |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2110-5820 |
| العلاقة: | http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4273700/pdfTest/; Annals of Intensive Care; Liu, K. D., J. G. Wilson, H. Zhuo, L. Caballero, M. L. McMillan, X. Fang, K. Cosgrove, et al. 2014. “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.” Annals of Intensive Care 4 (1): 22. doi:10.1186/s13613-014-0022-z. http://dx.doi.org/10.1186/s13613-014-0022-zTest.; http://nrs.harvard.edu/urn-3:HUL.InstRepos:13890771Test |
| DOI: | 10.1186/s13613-014-0022-z |
| الإتاحة: | https://doi.org/10.1186/s13613-014-0022-zTest http://nrs.harvard.edu/urn-3:HUL.InstRepos:13890771Test |
| رقم الانضمام: | edsbas.B60334A2 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 21105820 |
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| DOI: | 10.1186/s13613-014-0022-z |