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Serious adverse events of cell therapy for respiratory diseases: a systematic review and meta-analysis
- Source :
- Oncotarget
- Publication Year :
- 2017
- Publisher :
- Impact Journals, LLC, 2017.
-
Abstract
- // Runzhen Zhao 1,* , Zhenlei Su 2,* , Jing Wu 2 and Hong-Long Ji 1 1 Texas Lung Injury Institute, University of Texas Health Northeast, Tyler, Texas, USA 2 Institute of Lung and Molecular Therapy, Xinxiang Medical University, Xinxiang, Henan, China * These authors have contributed equally to this work Correspondence to: Hong-Long Ji, email: // Keywords : serious adverse events, cell therapy, respiratory diseases, systematic review, meta-analysis Received : January 17, 2017 Accepted : February 08, 2017 Published : February 16, 2017 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.
- Subjects :
- 0301 basic medicine
Spirometry
medicine.medical_specialty
ARDS
Respiratory Tract Diseases
Cell- and Tissue-Based Therapy
Review
Lung injury
03 medical and health sciences
Idiopathic pulmonary fibrosis
0302 clinical medicine
systematic review
Internal medicine
Odds Ratio
medicine
Humans
030212 general & internal medicine
Adverse effect
Intensive care medicine
Clinical Trials as Topic
COPD
Lung
medicine.diagnostic_test
respiratory diseases
business.industry
Mesenchymal Stem Cells
medicine.disease
meta-analysis
Treatment Outcome
030104 developmental biology
medicine.anatomical_structure
Oncology
Bronchopulmonary dysplasia
serious adverse events
cell therapy
business
Subjects
Details
- ISSN :
- 19492553
- Volume :
- 8
- Database :
- OpenAIRE
- Journal :
- Oncotarget
- Accession number :
- edsair.doi.dedup.....ab122ca60894b4d52fa96b8be465d8c2