作者
Michael A Matthay, Carolyn S Calfee, Hanjing Zhuo, B Taylor Thompson, Jennifer G Wilson, Joseph E Levitt, Angela J Rogers, Jeffrey E Gotts, Jeanine P Wiener-Kronish, Ednan K Bajwa, Michael P Donahoe, Bryan J McVerry, Luis A Ortiz, Matthew Exline, John W Christman, Jason Abbott, Kevin L Delucchi, Lizette Caballero, Melanie McMillan, David H McKenna, Kathleen D Liu
发表日期
2019/2/1
期刊
The Lancet Respiratory Medicine
卷号
7
期号
2
页码范围
154-162
出版商
Elsevier
简介
Background
Treatment with bone-marrow-derived mesenchymal stromal cells (MSCs) has shown benefits in preclinical models of acute respiratory distress syndrome (ARDS). Safety has not been established for administration of MSCs in critically ill patients with ARDS. We did a phase 2a trial to assess safety after administration of MSCs to patients with moderate to severe ARDS.
Methods
We did a prospective, double-blind, multicentre, randomised trial to assess treatment with one intravenous dose of MSCs compared with placebo. We recruited ventilated patients with moderate to severe ARDS (ratio of partial pressure of oxygen to fractional inspired oxygen <27 kPa and positive end-expiratory pressure [PEEP] ≥8 cm H2O) in five university medical centres in the USA. Patients were randomly assigned 2:1 to receive either 10 × 106/kg predicted bodyweight MSCs or placebo, according to a computer-generated …
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MA Matthay, CS Calfee, H Zhuo, BT Thompson… - The Lancet Respiratory Medicine, 2019