Abstract
BackgroundCell therapy holds the most promising for acute and chronic deleterious respiratory diseases. However, the safety and tolerance for lung disorders are controversy.MethodsWe 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.Results342 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.ConclusionsWe 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.
Highlights
Acute inflammatory and chronic fibrotic lung diseases have a high mortality and morbidity worldwide, including acute respiratory distress syndrome (ARDS) [1], bronchopulmonary dysplasia (BPD), pulmonary arterial hypertension (PAH), silicosis, sarcoidosis, extensively drug-resistant tuberculosis (XDRTB), chronic obstructive pulmonary diseases (COPD), and idiopathic pulmonary fibrosis (IPF)
Because of the need for better therapeutics, several preclinical studies have examined the benefit of different stem cell preparations, providing support for the clinical trials of cell therapy [2,3,4,5,6,7]
The odds ratio (OR) of total non-fatal SAEs was 1.53, indicating that the probability of non-fatal SAEs for cell therapy was 1.5 fold www.impactjournals.com/oncotarget that of controls (Figure 3A)
Summary
Acute inflammatory and chronic fibrotic lung diseases have a high mortality and morbidity worldwide, including acute respiratory distress syndrome (ARDS) [1], bronchopulmonary dysplasia (BPD), pulmonary arterial hypertension (PAH), silicosis, sarcoidosis, extensively drug-resistant tuberculosis (XDRTB), chronic obstructive pulmonary diseases (COPD), and idiopathic pulmonary fibrosis (IPF). Because of the need for better therapeutics, several preclinical studies have examined the benefit of different stem cell preparations, providing support for the clinical trials of cell therapy [2,3,4,5,6,7]. Clinical trials are predominately phase 1 and heterogeneous in the source, preparation, route, dose, duration, variables of outcome, and the nature of diseases. The small number of patients enrolled in each of these clinical trials makes it difficult to evaluate safety and tolerance based on a single trial alone. Et al 9 moderate/severe ARDS 54.9 ± 16.2y. Zheng G et al 2014[10] 12 moderate ARDS (6:6). The safety and tolerance for lung disorders are controversy
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