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Meta-Analysis
. 2017 May 2;8(18):30511-30523.
doi: 10.18632/oncotarget.15426.

Serious adverse events of cell therapy for respiratory diseases: a systematic review and meta-analysis

Runzhen Zhao  1 , Zhenlei Su  2 , Jing Wu  2 , Hong-Long Ji  1
Affiliations
Meta-Analysis

Serious adverse events of cell therapy for respiratory diseases: a systematic review and meta-analysis

Runzhen Zhao et al. Oncotarget. .

Abstract

Background: Cell therapy holds the most promising for acute and chronic deleterious respiratory diseases. However, the safety and tolerance for lung disorders are controversy.

Methods: We undertook a systematic review and meta-analyses of all 23 clinical studies of cell therapy. The outcomes were odds ratio (OR), risk difference (RD), Peto OR, relative risk, and mean difference of serious adverse events.

Results: 342 systemic infusions and 57 bronchial instillations (204 recipients) of cells were analyzed for acute respiratory distress syndrome (ARDS), bronchopulmonary dysplasia, pulmonary arterial hypertension, silicosis, sarcoidosis, extensively drug-resistant tuberculosis, chronic obstructive pulmonary diseases (COPD), and idiopathic pulmonary fibrosis. The frequency of death in adults from any causes was 71 and 177 per 1,000 for cell therapy and controls, respectively, with an OR of 0.31 (95% CI: 0.03, 3.76) and RD of -0.22 (95% CI: -0.53, 0.09). No significant difference was found for ARDS and COPD. The frequency of deaths and non-fatal serious adverse events of 17 open studies were similar to those of randomized controlled trials. Moreover, serious adverse events of allogenic cells were greater than autologous preparations, as shown by frequency, OR and RD.

Conclusions: We conclude that either infusion or instillation of mesenchymal stem stromal or progenitor cells are well tolerated without serious adverse events causally related to cell treatment. Cell therapy has not been associated with significant changes in spirometry, immune function, cardiovascular activity, and the quality of life.

Keywords: cell therapy; meta-analysis; respiratory diseases; serious adverse events; systematic review.

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Conflict of interest statement

CONFLICTS OF INTEREST

The authors have no conflicts of interest to report.

Figures

Figure 1
Figure 1. Flow diagram summarizing selection of clinical trials for meta-analysis and systematic review
Figure 2
Figure 2. Forest plots for total death in six controlled studies
Odd ratio A. and risk difference B.
Figure 3
Figure 3. Forest plots for non-fatal serious adverse events in six controlled studies
Odd ratio A. and risk difference B.
See this image and copyright information in PMC

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