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Background
Acute respiratory distress syndrome (ARDS) is the devastating complication of the new COVID-19 pandemic, directly correlated with releasing large amounts of inflammatory cytokines. Due to their immunoregulatory features, mesenchymal stromal cells (MSCs) provide a promising approach against this disease. In this regard, this study was designed as a single-center, open-label, phase 1 clinical trial with a control group to examine the safety and explore the possible potency of three injections of umbilical cord-derived MSCs (UC-MSCs) in mild–moderate COVID-19-induced ARDS patients.
Methods
Twenty confirmed COVID-19 patients with mild-to-moderate ARDS degree entered the study and were divided into two groups: control group (standard care) and intervention group (standard care + UC-MSCs). The patients received three intravenous infusions of UC-MSCs (1 × $${10}^{6}$$
10
6
cells/kg BW per injection) every other day. Respiratory markers, CRP levels and specific serum cytokines were assessed four times (days of 0, 5, 10 and 17) during the 17-day follow-up period.
Results
During the study, there were no serious adverse effects after cell transplantations. Besides, significant improvement in SPO2/FIO2 ratio and serum CRP levels was observed. On the other hand, a significant decrease (P < 0.05) in serum cytokine levels of IL-6, IFN-g, TNF-α, IL-17 A and a significant increase in serum cytokine levels of TGF-B, IL-1B and IL-10 were observed. Also, no significant changes were observed in CT scan images of patients during the study period.
Conclusion
Our obtained results demonstrated that multiple intravenous transplantations of allogenic UC-MSCs in non-severe COVID-19-induced ARDS patients are a safe procedure. In addition, this intervention is a hopeful approach to decline cytokine storm and recover respiratory functions. Indeed, more clinical trials with larger sample sizes are required to confirm these results.
Trial registration This clinical trial was registered with the Iranian Registry of Clinical Trials (ID: IRCT20160809029275N1 at 2020.05.30).
Background:The level of occupational violence against nurses increases from 68.8 to 98.6 percent, which is a considerable rate among healthcare settings. To create a safe environment for patient care in the emergency department (ED), a comprehensive program for the prevention of violence is necessary. The aim of this study was to plan a workplace violence prevention program (WVPP) to reduce the level of patients' and their families' violence against nurses.Materials and Methods:The present study is a quantitative part of a participatory action research project conducted in an 18-month period from October 2012 to May 2014 in an ED of Iran. In the diagnosing phase, we used quantitative and qualitative approaches. The second and third phases were assigned to design and implementation of WVPP involving a combination of educational and managerial interventions. In the evaluation phase, frequencies of patients' and their families' violence against nurses and nurses' fear of violence were measured.Results:Mc-Nemar test showed that 85.70% (n = 42) frequencies of verbal violence before implementing WVPP significantly decreased to 57.10% (n = 28) after implementing WVPP (p = 0.007). Statistical-dependent t-test (p < 0.001) indicated a significant difference in the mean (SD) scores of nurses' fear of violence before 46.10 (8.3) and after intervention 34.30 (4.6).Conclusions:Applying educational and managerial interventions was effective in reduction of workplace violence. Thus, it is recommended to include a combined approach in designing WVPP in cultures similar to Iran and pay attention to effective interactions with patients' family.
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