The safety profile of mesenchymal stem cell therapy administered through intrathecal injections for treating neurological disorders: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Based on previous in vivo studies and human trials, intrathecal cell delivery is a safe and relevant therapeutic tool for improving patient's quality of life with neurological conditions. We aimed to characterise the safety profile of intrathecally delivered Mesenchymal stem cells (MSCs). METHODS: Ovid MEDLINE, Embase, Scopus, Cochrane Library, KCI-Korean Journal Database, and Web of Science. Databases were searched from their inception until April 13, 2023. Randomised Controlled Trials (RCTs) that compared intrathecal delivery of MSCs to controls in adult populations were included. Adverse events (AEs) were pooled and meta-analysed using DerSimonian-Laird random effects models with a correction factor 0.5 added to studies with zero count cells. Pooled AEs were described using Risk ratio (RR) and 95% confidence intervals (95% CI). Then, a random-effects meta-regress model on study-level summary data was performed to explore the relationship between the occurrence of AEs and covariates thought to modify the overall effect estimate. Finally, publication bias was assessed. RESULTS: 303 records were reviewed, and nine RCTs met the inclusion criteria and were included in the quantitative synthesis (n = 540 patients). MSCs delivered intrathecally, as compared to controls, were associated with an increased probability of AEs of musculoskeletal and connective tissue disorders (categorised by Common Terminology Criteria for Adverse Events-CTCAE version 5.0) (RR: 1.61, 95% CI 1.19-2.19, I2 = 0%). The random-effects meta-regress model suggested that fresh MSCs increased the probability of occurrence of AEs compared to cryopreserved MSCs (RR: 1.554; p-value = 0.048; 95% CI 1.004-2.404), and the multiple-dose, decreased the probability of AEs by 36% compared to single doses (RR: 0.644; p-value = 0.048; 95% CI 0.416-0.996); however, univariate random effects meta-regression models revealed a not significant association between the occurrence of AEs from MSCs intrathecal delivery and each covariate. CONCLUSIONS: Intrathecal delivery of MSCs was associated with a slight increase in AEs associated with musculoskeletal and connective tissue disorders, albeit without serious AEs. We conclude that intrathecal MSCs delivery is safe for patients with neurological conditions. However, further high-quality, large-scale RCTs are needed to confirm these findings.

Recomendaciones para reumatólogos sobre el manejo farmacológico durante la emergencia sanitaria por COVID-19: opinión de un grupo de expertos / Recommendations for rheumatologists on pharmacological management during the COVID-19 health emergency: Expert group opinion

RESUMEN La enfermedad por Coronavirus 2019 (COVID-19) es una pandemia inesperada que ha pro vocado un estado de emergencia y que ha generado cambios drásticos en los protocolos de atención clínica. Para su tratamiento se ha descrito el papel de algunos medicamen tos usados habitualmente en artritis reumatoide, lupus eritematoso sistémico y otras enfermedades autoinmunitarias sistémicas. Debido a ello, existe un inminente riesgo de desabastecimiento, por lo cual el objetivo de esta revisión narrativa y opinión de expertos es formular recomendaciones generales clínicas y administrativas sobre el manejo de pacien tes ambulatorios con enfermedad autoinmunitaria o inflamatoria sistémica en el contexto de la pandemia por COVID-19.

ABSTRACT Coronavirus 2019 (COVID-19) is an unexpected pandemic that has caused a state of emergency, as well as generating drastic changes in clinical care protocols. Some drugs commonly used in rheumatoid arthritis, systemic lupus erythematosus, and other systemic autoimmune diseases have been described for its treatment. Therefore, there is an imminent risk of shortages. The aim of this narrative review and expert opinion is to present general recommendations on the clinical and administrative management of outpatients with autoimmune or systemic inflammatory disease, in the context of the COVID-19 pandemic.

Exposición periconcepcional a factores ambientales y de consumo en padres y cuidadores de niños menores de 5 años en Santander / Periconceptional Exposure to Environmental and Consumer Factors in Parents and Caregivers of Children Under 5 Years Old in Santander / Exposição periconcepcional aos fatores ambientais e do consumo dos pais e dos cuidadores de crianças menores de 5 anos de idade no estado de Santander

Introducción: El desarrollo de estrategias que faciliten el cribado, diagnóstico y abordaje de factores medioambientales durante el embarazo y la lactancia, etapas donde la salud materno-infantil está expuesta de manera activa o pasiva a diferentes agentes; requiere implementar formatos facilitadores de abordaje preventivo. Objetivo: Identificar los factores medioambientales, desde la etapa periconcepcional hasta la infancia, utilizando como herramienta compartida la hoja verde de salud ambiental. Metodología: Estudio observacional, descriptivo de corte transversal. La muestra fue de 204 mujeres gestantes y/o lactantes entre 13-46 años de edad, de municipios de Santander. Se realizó un análisis estadístico descriptivo, de acuerdo a la naturaleza de las variables. Resultados: La edad promedio fue de 25.12 años (DE=5.94). El promedio de semanas gestacionales fue de 36.65 (DE=5.63). Consumo de alcohol preconcepciónal del 48.52% (n=99), donde 91.91% (n=91) consumió cerveza con frecuencia de consumo pregestacional de 4.96 cervezas/mes (DE= 4.58) (n=64). El consumo de cigarro materno en etapas periconcepcionales, fue de 4.90% con promedio de 2.03 cigarros/día (DE=4.35). Conclusiones: Este estudio aporta datos del ámbito local, y traslada una herramienta válida de promoción y prevención en salud medioambiental, por lo que la aplicación de este instrumento permitiría el abordaje integral de la consulta de atención madre-hijo.

Introduction: The development of strategies that facilitate the screening, diagnosis and approach of environmental factors during pregnancy and lactation, stages in which maternal and child health is exposed in an active or passive way to different agents; it requires implementing facilitative formats of a preventive approach. Objective: To identify environmental factors, from the periconceptional stage to childhood by using the "Green Page" of environmental health as a shared tool. Methodology: This is an observational and descriptive cross-sectional study. The sample consisted of 204 pregnant women and / or infants between 13 - 46 years old, from different municipalities in Santander. According to the nature of the variables, a descriptive statistical analysis was carried out. Results: The average age was 25.12 years (SD = 5.94). The pregnancy weeks average was 36.65 (SD = 5.63). Preconception of alcohol intake of 48.52% (n = 99), in which 91.91% (n = 91) consumed beer with a frequency of pre-pregnancy intake of 4.96 beers / month (SD = 4.58) (n = 64). The cigar intake of women in periconceptional stages was 4.90% with an average of 2.03 cigars / day (SD = 4.35). Conclusions: This study provides data from the local area, and moves a valid tool promotion and prevention tool to environmental health, so the application of this instrument would allow the integral approach of the mother-child care consultation.

Introdução: O desenvolvimento de estratégias que facilitem a triagem, o diagnóstico e a abordagem dos fatores ambientais durante a gestação e a lactação, etapas em que a saúde materno-infantil é exposta de maneira ativa ou passiva a diferentes agentes; requer a implementação de formatos facilitadores d'abordagem preventiva. Objetivo: Identificar fatores ambientais, desde a fase periconcepcional até a infância, utilizando a folha verde da saúde ambiental como ferramenta compartilhada. Metodologia: De tipo descritivo, de observação, e transversal. A amostra realizada foi de 204 gestantes e/ ou lactantes entre 13 e 46 anos de idade, de diferentes municípios de Santander. De acordo com a natureza das variáveis, se realizou uma análise estatística descritiva. Resultados: A idade média foi de 25,12 anos (DP = 5,94). O pro médium de semanas, nas gestantes foi de 36,65 (DP = 5,63). O consumo de álcool na pré concepção é de 48,52% (n = 99), entre ellas, 91,91% (n = 91) beberam cerveja com frequência de 4,96 cervejas ao mês (DE= 4,58) (n = 64). As mães fumadoras no periodo da pré concepção foi de 4,90%, com um pro médium de 2,03 cigarros por dia (DP = 4,35). Conclusões: O estudo apresenta os dados da região e usa uma ferramenta válida de promoção e prevenção em saúde ambiental, para que a aplicação deste instrumento permita a abordagem integral da consulta e dos cuidados materno-infantil, nos casos atendidos.