Subject(s)
Coronavirus Infections , Exosomes , Mesenchymal Stem Cells , Pandemics , Pneumonia, Viral , Betacoronavirus , COVID-19 , Humans , SARS-CoV-2ABSTRACT
This prospective nonrandomized open-label cohort study addresses the safety and efficacy of exosomes (ExoFlo™) derived from allogeneic bone marrow mesenchymal stem cells as treatment for severe COVID-19. During April 2020, ExoFlo was provided to 24 SARS-CoV-2 polymerase chain reaction-positive patients at a single hospital center, all of whom met criteria for severe COVID-19 as well as moderate-to-severe acute respiratory distress syndrome. Patients received a single 15 mL intravenous dose of ExoFlo and were evaluated for both safety and efficacy from days 1 to 14 post-treatment. All safety endpoints were met with no adverse events observed within 72 h of ExoFlo administration. A survival rate of 83% was observed. In total, 17 of 24 (71%) patients recovered, 3 of 24 (13%) patients remained critically ill though stable, and 4 of 24 (16%) patients expired for reasons unrelated to the treatment. Overall, after one treatment, patients' clinical status and oxygenation improved with an average pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) increase of 192% (P < 0.001). Laboratory values revealed significant improvements in absolute neutrophil count [mean reduction 32% (P value <0.001)] and lymphopenia with average CD3+, CD4+, and CD8+ lymphocyte counts increasing by 46% (P < 0.05), 45% (P < 0.05), and 46% (P < 0.001), respectively. Likewise, 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. In conclusion, owing to its safety profile, capacity to restore oxygenation, downregulate cytokine storm, and reconstitute immunity, ExoFlo is a promising therapeutic candidate for severe COVID-19. Future randomized controlled trials (RCTs) are needed to determine ExoFlo therapeutic potential.
Subject(s)
Bone Marrow Cells/cytology , Coronavirus Infections/therapy , Critical Illness/therapy , Exosomes/transplantation , Mesenchymal Stem Cell Transplantation , Mesenchymal Stem Cells/cytology , Pneumonia, Viral/therapy , Adult , Aged , Aged, 80 and over , Betacoronavirus/pathogenicity , COVID-19 , Cell-Derived Microparticles/transplantation , Cohort Studies , Coronavirus Infections/mortality , Critical Illness/mortality , Female , Humans , Male , Mesenchymal Stem Cell Transplantation/adverse effects , Mesenchymal Stem Cell Transplantation/methods , Mesenchymal Stem Cells/ultrastructure , Middle Aged , Pandemics , Pneumonia, Viral/mortality , SARS-CoV-2 , Severity of Illness Index , Treatment OutcomeABSTRACT
Antecedentes: La reconstrucción de la pared abdominal tiene como fin restaurar el soporte estructural, otorgando una cobertura estable y optimizando la apariencia estética. La técnica de separación de componentes consiste en el avance medial de un componente muscular y fascial inervados, para reconstruir defectos en la línea media, logra un cierre sin tensión y ayuda a recrear la dinámica de la pared abdominal. Objetivo: El objetivo del siguiente trabajo es presentar la experiencia del Hospital de Carabineros en la reconstrucción de tales defectos utilizando esta técnica y evaluar la tasa de recidiva. Material y método: Estudio retrospectivo de pacientes operados en el Hospital entre 2010 y 2015. Se describe la técnica quirúrgica utilizada.Resultados: Se presenta una serie de 6 pacientes operados en dicho período. El tamaño promedio del defecto fue 272,8 cm². Se utilizó la técnica clásica de separación de componentes y en algunos casos modificaciones para preservar perforantes. La cirugía tuvo una duración de 185 min en promedio. No se han presentado recidivas a la fecha entre los pacientes operados (seguimiento promedio 16,8 meses). Conclusiones: La técnica de separación de componentes repara defectos extensos de manera anatómica, autógena y devolviendo la funcionalidad a la pared abdominal. Es un procedimiento que no está libre de complicaciones, sin embargo, en nuestra experiencia los resultados son estables en el tiempo sin evidenciar recidivas. Se recomienda una adecuada evaluación y selección de cada caso.
Background: The component separation technique is a type of rectus abdominis muscle advancement flap that allows reconstruction of such large ventral defects. The advantages of the component separation technique are that it restores functional and structural integrity of the abdominal wall, provides stable soft tissue coverage, and optimizes aesthetic appearance. Aim: To report our experience in abdominal reconstruction using this technique. Material and methods: Review of medical records of 6 patients subjected to an abdominal wall repair using the component separation technique. Results: The mean size of the abdominal wall defect was 272.8 cm². The classic technique or a modification to preserve perforator vessels were used. The mean surgical time was 185 minutes. After a follow up of 16.8 months, no relapses were observed. Conclusions: In this experience the component separation technique had good results and no relapse of the defect was observed.
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Abdominal Wall/surgery , Abdominoplasty/methods , Incisional Hernia/surgery , Postoperative Complications , Retrospective Studies , Follow-Up Studies , Treatment Outcome , Plastic Surgery Procedures , Abdominal Wall/anatomy & histology , Operative TimeABSTRACT
OBJECTIVE: To develop a new patient-reported outcome instrument (PRO) to measure body-related satisfaction quality of life (QoL). METHODS: Standard 3-phase PRO design was followed; in the first phase, a qualitative design was used in 45 patients to develop a conceptual framework and to create preliminary scale domains and items. In phase 2, large-scale population testing on 1340 subjects was performed to reduce items and domains. In phase 3, final testing of the developed instrument on 34 patients was performed. Statistics used include Factor, RASCH, and multivariate regression analysis. Psychometric properties measured were internal reliability, item-rest, item-test, and test-retest correlations. RESULTS: The PRO-developed instrument is composed of four domains (satisfaction with the abdomen, sex life, self-esteem and social life, and physical symptoms) and 20 items in total. The score can range from 20 (worst) to 100 (best). Responsiveness was 100 %, internal reliability 93.3 %, and test-retest concordance 97.7 %. Body image-related QoL was superior in men than women (p < 0.001) and decreased with increasing age (p = 0.004) and BMI (p < 0.001). Post-bariatric body contouring patients score lower than cosmetic patients in all domains of the Body-QoL instrument (p < 0.001). After surgery, the score improves by on average 21.9 ± 16.9 (effect size 1.8, p < 0.001). CONCLUSIONS: Body satisfaction-related QoL can be measured reliably with the Body-QoL instrument. It can be used to quantify the improvement in cosmetic and post-bariatric patients including non- or minimally invasive procedures, suction assisted lipectomy, abdominoplasty, lipoabdominoplasty, and lower body lift and to give an evidence-based approach to standard practice. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
Subject(s)
Abdominoplasty , Lipectomy , Patient Reported Outcome Measures , Patient Satisfaction , Quality of Life , Adolescent , Adult , Aged , Beauty , Female , Humans , Male , Middle Aged , Young AdultABSTRACT
Contiene: Las bases conceptuales de Soros - Mercados financieros - Sociedad transnacional - La sociedad abierta como ideal - El individuo hipotecado - El capital golondrina - Qué hacer para evitar el desplome - Otro mundo es posible
