Safety and efficacy study of allogeneic human menstrual blood stromal cells secretome to treat severe COVID-19 patients: clinical trial phase I & II.

BACKGROUND: Cell-free Mesenchymal stromal cells (MSCs) have been considered due to their capacity to modulate the immune system and suppress cytokine storms caused by SARS-CoV-2. This prospective randomized double-blind placebo-controlled clinical trial aimed to assess the safety and efficacy of secretome derived from allogeneic menstrual blood stromal cells (MenSCs) as a treatment in patients with severe COVID-19. METHODS: Patients with severe COVID-19 were randomized (1:1) to either MenSC-derived secretome treatment or the control group. Subjects received five intravenous infusions of 5 mL secretome or the same volume of placebo for five days and were monitored for safety and efficacy for 28 days after treatment. Adverse events, laboratory parameters, duration of hospitalization, clinical symptom improvement, dynamic of O2 saturation, lymphocyte number, and serial chest imaging were analyzed. RESULTS: All safety endpoints were observed without adverse events after 72 h of secretome injection. Within 28 days after enrollment, 7 patients (50%) were intubated in the treated group versus 12 patients (80%) in the control group. Overall, 64% of patients had improved oxygen levels within 5 days of starting treatment (P < 0.0001) and there was a survival rate of 57% in the treatment group compared to 28% in the control group was (P < 0.0001). Laboratory values revealed that significant acute phase reactants declined, with mean C-reactive protein, ferritin, and D-dimer reduction of 77% (P < 0.001), 43% (P < 0.001), and 42% (P < 0.05), respectively. Significant improvement in lymphopenia was associated with an increase in mean CD4+ and CD8+ lymphocyte counts of 20% (P = 0.06) and 15% (P < 0.05), respectively. Following treatment, percentage of pulmonary involvement showed a significant improvement in the secretome group (P < 0.0001). This improvement differed significantly between survivors and those who were dying (P < 0.005). CONCLUSIONS: For the first time, this study demonstrated that in hospitalized patients with severe COVID-19, therapy with MenSCs-derived secretome leads to reversal of hypoxia, immune reconstitution, and downregulation of cytokine storm, with no adverse effects attributable to the treatment. Given these outcomes, it may be possible to use this type of treatment for serious inflammatory lung disease with a mechanism similar to COVID-19 in the future. However, it is necessary to evaluate the safety and efficacy of MenSCs-derived secretome therapy in clinical trials on a larger population of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05019287. Registered 24AGUEST 2021, retrospectively registered, https://clinicaltrials.gov/ct2/show/record/NCT05019287 . IRCT, IRCT20180619040147N6. Registered 04/01/2021.

A comparison between over-the-head and lateral cardiopulmonary resuscitation with a single rescuer by bag-valve mask.

CONTEXT: mask fixation in the lateral position is difficult during CPR. AIM: the aim of this study is to compare the lateral CPR for the use of bag-valve mask by single paramedic rescuer as well as over-the-head CPR on the chest compression and ventilation on the manikin. SETTINGS AND DESIGN: Mazandaran University of Medical Sciences. The design of this study was a randomized cross-over trial. METHODS: participants learned a standardized theoretical introduction CPR according to the 2010 guidelines. The total number of chest compressions per two minutes was measured. Total number of correct and wrong ventilation per two minutes was evaluated. STATISTICAL ANALYSIS: we used Wilcoxon signed-rank test to analyze the non-normally distributed data in dependence groups A. P-value of more than 0.05 was considered to show statistical significance. RESULTS: there were 100 participants (45 women and 55 men) who participated in the study from September to March, 2011. The compression and ventilation rate in lateral CPR was lower than OTH CPR. Around 51% of participants had correct chest compression rate more than 90 beats per minute in lateral CPR and 65% of them had equal or more than ten correct ventilations per minute. CONCLUSIONS: in conclusion, this study confirmed that in a simulated CPR model over-the-head position CPR led to a better BLS than the lateral position CPR by a single paramedic student with a BVM device. We also concluded that by this new BVM fixation method on the face of the patients in the lateral position CPR can be a good alternative over-the-head mask fixation by a single trained rescuer.

Accuracy of estimation of total body weight by legs and head weight measuring and comparison method in the anesthetized patients.

CONTEXT: Accurate patient weight is an important factor in the emergency and operating room departments. AIMS: The aim of this study is to determine the accuracy of estimation of total body weight by legs and head weight measuring and comparison method in the anesthetized patients. SETTINGS AND DESIGN: Education of hospitals, Mazandaran University of Medical Sciences, prospective, observational study. SUBJECTS AND METHODS: This is prospective observational study. Nursing staff were asked to estimated weight that knows about a similar person weight on the operating room and matched together, then told his/her guests. They were measured total body weight before anesthesia and then patient head and legs weight after anesthesia. The main outcome was mean weight of these methods and percent accuracy in weight estimation for each group recorded. STATISTICAL ANALYSIS: Descriptive statistically used. RESULTS: Overall, 57.3% (243/425) of operating personnel estimations were equal with actual weight. 35.4% (150/425) of the estimations were less 10 kg than the actual weight and only 7.3 (31/425) of the estimations were above 5 kg of actual weight. The accuracy of overall estimations by operating personnel and its comparison to the accuracy of legs weight, head, and sum weight by a similar method is demonstrated. CONCLUSIONS: Despite having no formula in the critical intensive care and anesthesia region for estimation anesthetized, for comatose patient weight. We can use this formula, but where possible, should be based on measured weight for drug dose calculation and this is not possible, combination of these formulas is suitable.

Trazodone in methandone induced erectile dysfunction.

OBJECTIVE: Based on findings of previous studies, those men on Methadone Maintenance Therapy (MMT) have a high prevalence of Erectile Dysfunction(ED), related to hypogonadism and depression. We conducted this study to evaluate the efficacy of Trazodone (an antidepressant which can improve sexual function) on this sexual dysfunction. METHOD: A structured interview was administered by the clinical staff. The interview contained questions about the subjects' socio-demographic characteristics, their drug use and sexual behavior. In addition to the socio-demographic survey, erectile function was assessed using erectile dysfunction (ED) intensity scale. Of the 157 subjects, 95 suffered from ED. The subjects were informed about the study. Then, seventy five patients voluntarily received 50mg of Trazodone for four days, and the dosage was increased to100 mg and maintained for 6 weeks. Fifty five patients who completed the treatment course were assessed by ED questionnaire again at the end of study. Statistical analysis was performed using Stata 8 software. RESULTS: The prevalence of ED was 60.5% in our sample. The mean erectile dysfunction (ED) intensity scale was 12.21, and 16.78 before and after the treatment course respectively. (P<0.05) ED severity had no significant relation with age and type of substance dependency (P>0.05); but it had a significant relation with duration of Methadone therapy and Methadone daily dosage. (p<0.05) CONCLUSION: Trazodone may be effective in the treatment of methadone induced ED. Further studies with control groups and greater sample sizes are warranted.