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Open Access 01-12-2014 | Research

Treatment of acute respiratory distress syndrome with allogeneic adipose-derived mesenchymal stem cells: a randomized, placebo-controlled pilot study

Authors: Guoping Zheng, Lanfang Huang, Haijiang Tong, Qiang Shu, Yaoqin Hu, Menghua Ge, Keqin Deng, Liuya Zhang, Bin Zou, Baoli Cheng, Jianguo Xu

Published in: Respiratory Research | Issue 1/2014

Abstract

Background

Recent studies have demonstrated that mesenchymal stem cells (MSCs) modulate the immune response and reduce lung injury in animal models. Currently, no clinical studies of the effects of MSCs in acute respiratory distress syndrome (ARDS) exist. The objectives of this study were first to examine the possible adverse events after systemic administration of allogeneic adipose-derived MSCs in ARDS patients and second to determine potential efficacy of MSCs on ARDS.

Methods

Twelve adult patients meeting the Berlin definition of acute respiratory distress syndrome with a PaO₂/FiO₂ ratio of < 200 were randomized to receive allogeneic adipose-derived MSCs or placebo in a 1:1 fashion. Patients received one intravenous dose of 1 × 10⁶ cells/kg of body weight or saline. Possible side effects were monitored after treatment. Acute lung injury biomarkers, including IL-6, IL-8 and surfactant protein D (SP-D), were examined to determine the effects of MSCs on lung injury and inflammation.

Results

There were no infusion toxicities or serious adverse events related to MSCs administration and there were no significant differences in the overall number of adverse events between the two groups. Length of hospital stay, ventilator-free days and ICU-free days at day 28 after treatment were similar. There were no changes in biomarkers examined in the placebo group. In the MSCs group, serum SP-D levels at day 5 were significantly lower than those at day 0 (p = 0.027) while the changes in IL-8 levels were not significant. The IL-6 levels at day 5 showed a trend towards lower levels as compared with day 0, but this trend was not statistically significant (p = 0.06).

Conclusions

Administration of allogeneic adipose-derived MSCs appears to be safe and feasible in the treatment of ARDS. However, the clinical effect with the doses of MSCs used is weak, and further optimization of this strategy will probably be required to reach the goal of reduced alveolar epithelial injury in ARDS.

Trial registration

Clinical trials.gov, NCT01902082

Available only for authorised users

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Title: Treatment of acute respiratory distress syndrome with allogeneic adipose-derived mesenchymal stem cells: a randomized, placebo-controlled pilot study
Authors: Guoping Zheng
Lanfang Huang
Haijiang Tong
Qiang Shu
Yaoqin Hu
Menghua Ge
Keqin Deng
Liuya Zhang
Bin Zou
Baoli Cheng
Jianguo Xu
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: Respiratory Research / Issue 1/2014
Electronic ISSN: 1465-993X
DOI: https://doi.org/10.1186/1465-9921-15-39

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Treatment of acute respiratory distress syndrome with allogeneic adipose-derived mesenchymal stem cells: a randomized, placebo-controlled pilot study

Abstract

Background

Methods

Results

Conclusions

Trial registration

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Abstract

Background

Methods

Results

Conclusions

Trial registration

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