Abstract
Introduction: Necrotizing enterocolitis is an acute inflammatory disease of the intestine that can lead to necrosis and bowel perforation. It is a severe complication of preterm birth. It’s mortality rate is up to 50% and survival after necrotizing enterocolitis leads to long-term complications. The current treatment is supportive and includes bowel rest and decompression and antibiotics. Thus, new treatments are necessary to reduce mortality and morbidity. Mesenchymal stromal cells are known to have anti-inflammatory properties and might be a promising option for treatment. Here we present a protocol for a systematic review with the aim to explore the efficacy of cell therapies with mesenchymal stromal cells in animal models of necrotizing enterocolitis. The primary outcome is histological signs of necrotizing enterocolitis. Additional outcomes include survival, bowel perforation, gut permeability, gut motility, levels of inflammatory markers, cytokine levels and adverse events. Methods: We will conduct a systematic search of MEDLINE, Embase, and Web of Science databases. The retrieved records will be screened individually by two investigators. We will include all preclinical in vivo animal models of experimentally induced necrotizing enterocolitis that evaluate the efficacy of mesenchymal stromal cells or other cell therapy treatments. Outcome data will be extracted from each article and risk of bias assessment performed. Funnel plots and SYRCLE’s risk of bias tool for animal studies will be used. Data will be reported as ratios, divided in predefined subgroups where relevant. Conclusions: This systematic review aims to examine the efficacy of mesenchymal stromal cells in preclinical models of necrotizing enterocolitis and whether there is sufficient evidence to support a clinical trial of efficacy and safety of the treatment with mesenchymal stromal cells in infants with necrotizing enterocolitis.
Highlights
Necrotizing enterocolitis is an acute inflammatory disease of the intestine that can lead to necrosis and bowel perforation
Necrotizing enterocolitis (NEC) is an acute inflammatory disease of the intestine.[1,2]. It was first described by Mizrahi et al in 1965.3 This disease is characterized by inflammation and injury to the wall barrier of the intestine that can cause necrosis and that can lead to bowel perforation.[2,4,5]
We aim to conduct a systematic review of the benefits and harms of mesenchymal stromal cells (MSCs) therapy in preclinical models of NEC
Summary
Necrotizing enterocolitis is an acute inflammatory disease of the intestine that can lead to necrosis and bowel perforation. Necrotizing enterocolitis (NEC) is an acute inflammatory disease of the intestine.[1,2] It was first described by Mizrahi et al in 1965.3 This disease is characterized by inflammation and injury to the wall barrier of the intestine that can cause necrosis and that can lead to bowel perforation.[2,4,5] It is a major complication of preterm birth.[6,7] In Canada, the preterm birth rate is 7.7%8 and, on the basis of large databases, the mean prevalence of NEC in Canada and the United States is about 7% among infants with birth weight between 500 g and 1500 g1,9,10 with a mortality rate as high as 50% in neonates with a birth weight less than 1000 g.11,12. The most common known risk factors of NEC include low gestational age, low birth weight, exposure to infant formula-feeding and microbial dysbiosis.[2,4,13,14] The classic NEC pathophysiological process of intestinal injury appears to be related to a basic immaturity of host defences, culminating in an excessive inflammatory response, with serum cytokines and chemokines, especially IL-8 significantly elevated[15,16,17] and imbalance of the healthy microbiome
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