The safety and efficacy of both cell and gene therapies have been demonstrated in numerous preclinical and clinical trials. Chimeric antigen receptor T (CAR-T) cell therapy, which leverages the technologies of both cell and gene therapies, has also shown great promise for treating various cancers. Advancements in pertinent fields have also highlighted challenges faced while manufacturing cell and gene therapy products. Potential problems and obstacles must be addressed to ease the clinical translation of individual therapies. Literature reviews of representative cell-based, gene-based, and cell-based gene therapies with regard to their general manufacturing processes, the challenges faced during manufacturing, and QC specifications are limited. We review the general manufacturing processes of cell and gene therapies, including those involving mesenchymal stem cells, viral vectors, and CAR-T cells. The complexities associated with the manufacturing processes and subsequent QC/validation processes may present challenges that could impede the clinical progression of the products. This article addresses these potential challenges. Further, we discuss the use of the manufacturing model and its impact on cell and gene therapy.

Background/Aims: The prevalence of Helicobacter pylori-naive status is increasing. Nonetheless, biennial gastroscopy is recommended for all Koreans aged 40 to 75 years. This study aimed to determine whether gastric cancer screening guidelines could be changed according to H.pylori infection status and year of birth. Methods: Koreans who underwent serum assays and gastroscopy for gastric cancer screening between 2010 and 2016 were included if screening tests were followed up for ≥3 times. H.pylori infection was confirmed when invasive tests or 13 C-urea breath tests were positive. In the case of negative test findings, eradication history, serologically detected atrophy, and intestinal metaplasia/atrophy were checked for past infection. If all were absent, H. pylori-naive status was confirmed. Results: Two-thousand and two (256 H. pylori-naive, 743 past-infected, and 1,003 infected) Koreans underwent screening tests for 95.5±28.4 months. The mean year of birth in the naive group (1969±7) differed from those of the past-infected (1957±10, p<0.001) and infected (1958±10, p<0.001) groups. H. pylori-naive status was correlated with recent year of birth (r=0.368, p<0.001). No gastric tumors were observed among the naive participants (p=0.007), whereas 23 adenomas, 18 adenocarcinomas, and two neuroendocrine tumors were detected in 1.9% (14/743) of past-infected and 2.5% (25/1,003) of infected participants, including four infected participants with metachronous tumors. Conclusions The prevalence of H. pylori-naive status is increasing in young Koreans, and gastric tumors are rare in this population. Hence, biennial gastroscopy could be waived after the confirmation of naive status.

Objectives: This review presents a comprehensive overview of the rapidly evolving digital healthcare industry, aiming to provide a broad understanding of the recent landscape and directions for the future of digital healthcare. Methods: This review examines the key trends in sectors of the digital healthcare industry, which can be divided into four main categories: digital hardware, software solutions, platforms, and enablers. We discuss electroceuticals, wearables, standalone medical software, non-medical health management services, telehealth, decentralized clinical trials, and infrastructural systems such as health data systems. The review covers both global and domestic perspectives, addressing definitions, significance, revenue trends, major companies, regulations, and socioenvironmental factors. Results: Diverse growth patterns are evident across digital healthcare sectors. The applications of electroceuticals are expanding. Wearables are becoming more ubiquitous, facilitating continuous health monitoring and data collection. Artificial intelligence in standalone medical software is demonstrating clinical efficacy, with regulatory frameworks adapting to support commercialization. Non-medical health management services are expanding their scope to address chronic conditions under professional guidance. Telemedicine and decentralized clinical trials are gaining traction, driven by the need for flexible healthcare solutions post-pandemic. Efforts to build robust digital infrastructure with health data are underway, supported by data banks and data aggregation platforms. Conclusions Advancements in digital healthcare create a dynamic, transformative landscape, integrating, complementing, and offering alternatives to traditional paradigms. This evolution is driven by continuous innovation, increased stakeholder participation, regulatory adaptations promoting commercialization, and supportive initiatives. Ongoing discussions about optimal digital technology integration and effective healthcare strategy implementation are essential for progress.

Background: Over the last decade, extracorporeal membrane oxygenation (ECMO) use in critically ill children has increased and is associated with favorable outcomes. Our study aims to evaluate the current status of pediatric ECMO in Korea, with a specific focus on its volume and changes in survival rates based on diagnostic indications. Methods: This multicenter study retrospectively analyzed the indications and outcomes of pediatric ECMO over 10 years in patients at 14 hospitals in Korea from January 2012 to December 2021. Four diagnostic categories (neonatal respiratory, pediatric respiratory, postcardiotomy, and cardiac-medical) and trends were compared between periods 1 (2012–2016) and 2 (2017–2021). Results: Overall, 1065 ECMO runs were performed on 1032 patients, with the annual number of cases remaining unchanged over the 10 years. ECMO was most frequently used for post-cardiotomy (42.4%), cardiac-medical (31.8%), pediatric respiratory (17.5%), and neonatal respiratory (8.2%) cases. A 3.7% increase and 6.1% decrease in pediatric respiratory and post-cardiotomy cases, respectively, were noted between periods 1 and 2.Among the four groups, the cardiac-medical group had the highest survival rate (51.2%), followed by the pediatric respiratory (46.4%), post-cardiotomy (36.5%), and neonatal respiratory (29.4%) groups. A consistent improvement was noted in patient survival over the 10 years, with a significant increase between the two periods from 38.2% to 47.1% (P = 0.004). Improvement in survival was evident in post-cardiotomy cases (30–45%, P = 0.002).Significant associations with mortality were observed in neonates, patients requiring dialysis, and those treated with extracorporeal cardiopulmonary resuscitation (P < 0.001). In pediatric respiratory ECMO, immunocompromised patients also showed a significant correlation with mortality (P < 0.001). Conclusion Pediatric ECMO demonstrated a steady increase in overall survival in Korea;however, further efforts are needed since the outcomes remain suboptimal compared with global outcomes.

Background: Hand hygiene is considered the simplest and most cost-effective method of infection prevention. Regular observation and feedback on hand hygiene compliance are key strategies for its enhancement. This study evaluated the effectiveness of hand hygiene surveillance, including direct observation and feedback, by comprehensively analyzing the reported hand hygiene compliance within the Korean National Healthcare-Associated Infections Surveillance System from 2019 to 2022. Methods: Participating medical institutions included general hospitals and hospitals with infection control departments that consented to participate. Hand hygiene surveillance was conducted using direct observation. Collected data, including healthcare workers, clinical areas, hand hygiene moments, and hand hygiene compliance, were recorded to calculate hand hygiene compliance rates. Additionally, the volume of alcohol-based hand sanitizers used per patient per day was investigated as an indirect indicator of hand hygiene compliance. The study was conducted from July 2019 to December 2022. Results: Hand hygiene compliance increased from 87.2% in Q3 2019 to 89.9% in 2022. Nurses and medical technologists showed the highest compliance rates, whereas doctors showed the lowest compliance rates. Intensive care units excelled in compliance, whereas emergency de partments lagged. Compliance was highest after patient contact and lowest when the patient’s surroundings were touched. Larger hospitals consumed more alcohol-based hand sanitizers than smaller hospitals did. Conclusion This study confirmed an improvement in hand hygiene compliance through sustained surveillance, indicating its contribution not only to preventing infection transfer within healthcare facilities but also to fostering a culture of hand hygiene in the country.

Mutations within the SCN5A gene, which encodes the α-subunit 5 (NaV1.5) of the voltage-gated Na+ channel, have been linked to three distinct cardiac arrhythmia disorders: long QT syndrome type 3, Brugada syndrome (BrS), and cardiac conduction disorder. In this study, we have identified novel missense mutations (p.A385T/R504T) within SCN5A in a patient exhibiting overlap arrhythmia phenotypes. This study aims to elucidate the functional consequences of SCN5A mutants (p.A385T/R504T) to understand the clinical phenotypes. Whole-cell patch-clamp technique was used to analyze the NaV1.5 current (INa) in HEK293 cells transfected with the wild-type and mutant SCN5A with or without SCN1B co-expression. The amplitude of INa was not altered in mutant SCN5A (p.A385T/R504T) alone. Furthermore, a rightward shift of the voltage-dependent inactivation and faster recovery from inactivation was observed, suggesting a gain-of-function state. Intriguingly, the coexpression of SCN1B with p.A385T/R504T revealed significant reduction of INa and slower recovery from inactivation, consistent with the loss-of-function in Na+ channels. The SCN1B dependent reduction of INa was also observed in a single mutation p.R504T, but p.A385T co-expressed with SCN1B showed no reduction. In contrast, the slower recovery from inactivation with SCN1B was observed in A385T while not in R504T. The expression of SCN1B is indispensable for the electrophysiological phenotype of BrS with the novel double mutations; p.A385T and p.R504T contributed to the slower recovery from inactivation and reduced current density of NaV1.5, respectively.

Objective: This study aimed to investigate the impact of baseline values and temporal changes in body composition parameters, including skeletal muscle index (SMI) and visceral adipose tissue area (VAT), measured using serial computed tomography (CT) imaging on the prognosis of operable breast cancers in Asian patients. Materials and Methods: This study retrospectively included 627 Asian female (mean age ± standard deviation [SD], 53.6 ± 8.3 years) who underwent surgery for stage I–III breast cancer between January 2011 and September 2012. Body composition parameters, including SMI and VAT, were semi-automatically calculated on baseline abdominal CT at the time of diagnosis and follow-up CT for post-treatment surveillance. Serial changes in SMI and VAT were calculated as the delta values. Multivariable Cox regression analysis was used to evaluate the association of baseline and delta SMI and VAT values with disease-free survival. Results: Among 627 patients, 56 patients (9.2%) had breast cancer recurrence after a median of 40.5 months. The mean value ± SD of the baseline SMI and baseline VAT were 43.7 ± 5.8 cm2 /m2 and 72.0 ± 46.0 cm2 , respectively. The mean value of the delta SMI was -0.9 cm2 /m2 and the delta VAT was 0.5 cm2 . The baseline SMI and VAT were not significantly associated with disease-free survival (adjusted hazard ratio [HR], 0.983; 95% confidence interval [CI], 0.937–1.031; p = 0.475 and adjusted HR, 1.001; 95% CI, 0.995–1.006; p = 0.751, respectively). The delta SMI and VAT were also not significantly associated with disease-free survival (adjusted HR, 0.894; 95% CI, 0.766–1.043; p = 0.155 and adjusted HR, 1.001; 95% CI, 0.989–1.014; p = 0.848, respectively). Conclusion Our study revealed that baseline and early temporal changes in SMI and VAT were not independent prognostic factors regarding disease-free survival in Asian patients undergoing surgery for breast cancer.

Background: Since the era of “thyroid cancer epidemic,” many Korean academic societies discouraged the use of ultrasonography in healthy individuals and revised the Korean Thyroid Imaging Reporting and Data System to address the overscreening and overdiagnosis issues. This study aimed to evaluate the change in the diagnostic effectiveness of thyroid cancer screening over the last decade. Methods: This single-center, retrospective observational study analyzed the data of 125,962 thyroid nodules obtained during cancer screening at the health promotion center of Seoul National University Bundang Hospital from 2010 to 2019. Only 327 thyroid cancer cases pathologically confirmed by fine-needle aspiration (FNA) were included in the study. The strength of the association between the number of FNA and (1) the number of thyroid cancer diagnoses, (2) the positive predictive values (PPVs), and (3) the difference in PPV from the previous year were evaluated using Pearson’s correlation analysis. Results: The number of thyroid FNA biopsies as well as the thyroid cancer diagnoses decreased from 2010 to 2019 (166 to 48 [-71.1%] vs. 43 to 22 [-48.8%]). The PPV of FNA biopsies increased from 25.9% to 45.8% (+76.8%) and was negatively correlated with the number of FNA biopsies performed (R=-0.87, P<0.001). The difference in PPV from the previous year increased similarly but without statistical significance (R=-0.59, P=0.09). Conclusion The diagnostic efficiency of thyroid cancer screening has increased over the last decade, as evidenced by the increasing PPV of FNA biopsies.

Purpose: Mycoplasma pneumoniae pneumonia (MP) is a major cause of community-acquired pneumonia (CAP) in children and is associated with extrapulmonary manifestations (EPM). The incidence and risk factors for EPM in children are unknown. Methods: This was a retrospective study involving 65,243 pediatric patients with CAP between 2010 and 2015 at 23 nationwide hospitals in South Korea. Medical records were reviewed to collect information regarding the clinical characteristics, radiological results, and laboratory findings. Logistic regression with multivariate analysis was performed to evaluate the risk factors associated with EPM in MP. Results: The incidence of EPM was 23.9%, including elevation of liver enzymes (18.1%), mucocutaneous manifestations (4.4%), proteinuria (4.1%), cardiovascular and neurological manifestations (0.4%), hematologic manifestations (0.2%), and arthritis (0.2%). Statistical analysis showed that mucocutaneous manifestations significantly increased with elevated alanine aminotransferase (adjusted odds ratio [aOR], 3.623; 95% confidence interval [CI], 1.933-6.790) and atopic sensitization (aOR, 2.973; 95% CI, 1.615–5.475) and decreased with respiratory virus coinfection (aOR, 0.273; 95% CI, 0.084–0.887). Elevated liver enzymes were significantly associated with elevated lactate dehydrogenase (aOR, 3.055; 95% CI, 2.257–4.137), presence of pleural effusion (aOR, 2.635; 95% CI, 1.767–3.930), and proteinuria with respiratory virus coinfection (aOR, 2.245; 95% CI, 1.113–4.527). Conclusion Approximately 24% of pediatric patients with MP had various EPM. As the risk factors associated with each EPM were different, it is necessary to evaluate the various clinical aspects and findings of MP to predict and prepare for the occurrence of EPM.