An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.

Purpose: To evaluate the effect of adalimumab in pediatric uveitis and subsequent changes in anterior chamber inflammation following the inactivation of uveitis. Methods: In this retrospective study, patients with noninfectious uveitis younger than 18 years of age who were treated with adalimumab for more than 12 months were included. The rate of complete suppression and the relapse in anterior chamber inflammation following the initiation of adalimumab therapy were evaluated using anterior chamber cell score and laser flare photometry (LFP) values, if available. Changes in visual acuity and the sparing effect of topical steroid agents were also evaluated. Results: Among 22 eyes of 12 pediatric uveitis patients enrolled, 13 eyes were associated with juvenile idiopathic arthritis and nine eyes had idiopathic uveitis. The mean ± standard deviation age was 10.2 ± 3.6 years. Types of uveitis included ante-rior uveitis (n = 17) and panuveitis (n = 5). Quiescence was observed in 14 eyes (63.6%) at 3 months and in 21 eyes (95.5%) at 12 months after initiation, respectively. After achieving inactive uveitis, uveitis relapsed in two eyes at 6 months, even with adalimumab treatment. In 11 eyes, anterior chamber showed 0.5+ cell scores during the rest of the follow-up period and one of those eyes met the criteria for the relapse based on LFP values. The dosage of topical steroids decreased significantly at 3, 9, and 12 months after the initiation of therapy (p ≤ 0.05). Visual acuity did not show improvement. There were no severe adverse effects of anti-tumor necrosis factor-α treatment reported. Conclusions In this study, adalimumab achieved a quiescent state in most eyes with pediatric noninfectious uveitis for 12 months with a relapse rate of 9.5%. LFP values together with the anterior chamber cell score can be utilized to monitor the improvement or relapse in anterior chamber inflammation in pediatric noninfectious uveitis.

BACKGROUND/AIMS: Proton pump inhibitors (PPIs) are widely used in the treatment of gastroesophageal reflux disease (GERD). However, some patients fail to respond to PPI therapy. We investigated the efficacy of response to PPI therapy in patients with GERD symptoms. METHODS: A total of 179 subjects with GERD symptoms were prospectively enrolled and diagnosed with non-erosive reflux disease (NERD, n = 100) and erosive reflux disease (n = 79) by gastroscopy and Bernstein test and/or 24-hour esophageal pH testing. Subjects then received a standard dose of daily PPI therapy for at least 4 weeks. PPI therapy response was evaluated using questionnaires including questions about demographics, GERD symptoms, GERD impact scale, Epworth sleepiness scale, Pittsburgh sleep quality index (PSQI), hospital anxiety and depression scale, and abbreviated version of the World Health Organization quality of life scale. RESULTS: The rates of complete (> or = 80%), satisfactory (> or = 50%), partial (< 50%), and refractory response in the 179 participants were 41.3%, 30.2%, 18.4%, and 10.1%, respectively. Thus, overall response rate (complete and satisfactory responses) was 71.5%. Multivariate analysis showed body mass index < 23 kg/m2 (OR, 2.20; 95% CI, 1.12-4.34), higher total PSQI score (OR, 1.20; 95% CI, 1.05-1.35), history of psychotherapy or neuropsychiatric medication (OR, 2.44; 95% CI, 1.23-4.85), and NERD (OR, 3.30; 95% CI, 1.54-7.11) were associated with poor response to PPI therapy. CONCLUSIONS: Psychological factors, sleep dysfunction, body mass index < 23 kg/m2, and NERD seem to be the major factors that lead to a poor response to PPI treatment in patients with GERD symptoms.
Anxiety ; Body Mass Index ; Demography ; Depression ; Esophagitis ; Gastroesophageal Reflux* ; Gastroscopy ; Humans ; Hydrogen-Ion Concentration ; Multivariate Analysis ; Prospective Studies ; Proton Pump Inhibitors* ; Psychology ; Psychotherapy ; Quality of Life ; Surveys and Questionnaires ; Sleep Wake Disorders ; World Health Organization

BACKGROUND/AIMS: Gastric mucosal atrophy and intestinal metaplasia due to Helicobacter pylori infection are the main precursor lesions of gastric cancer. The aim of this study was to evaluate the long-term effects of H. pylori eradication on the progression of precancerous lesions to metachronous cancer after endoscopic resection of early gastric cancer (EGC). METHODS: Patients who underwent endoscopic resection of EGC were retrospectively reviewed. Changes in precancerous lesions and development of metachronous cancer were compared according to H. pylori eradication and final infection status. RESULTS: In total, 565 patients were followed for over 5 years after endoscopic resection of EGC. The grade of atrophy on corpus was significantly lower in the H. pylori-eradicated group than in the persistent group during follow-up (p=0.029). In patients < 70 years of age, the cumulative incidence rate of metachronous cancer was significantly lower in the H. pylori-eradicated group than in the persistent group (p=0.018). Age was an independent risk factor for metachronous cancer development. CONCLUSIONS: H. pylori eradication might prevent the development of metachronous cancer in patients < 70 years of age by delaying the progression of precancerous lesions after endoscopic resection of EGC.
Atrophy ; Follow-Up Studies ; Helicobacter pylori* ; Helicobacter* ; Humans ; Incidence ; Metaplasia ; Retrospective Studies ; Risk Factors ; Stomach Neoplasms*

This report presents guidelines for the systematic management of packaging, storage, transportation, and traceability of source cells used for organoid research. Given the important role of source cells in organoid studies, it is important to ensure the preservation of their quality and integrity throughout transportation and distribution processes. The proposed guidelines, therefore, call for a cohesive strategy through these stages to minimize the risks of contamination, deterioration, and loss–threats that significantly compromise the safety, efficacy, and efficiency of source cells. Central to these guidelines is the quality control measures that include roles and responsibilities across the entire supply chain, with recommendations specific to packaging materials, transportation facilities, and storage management. Furthermore, the need for an integrated management system is emphasized, spanning from source cell collection to the final application. This system is crucial for maintaining the traceability and accountability of source cells, facilitating the sharing, distribution, and utilization on a global scale, and supporting to advance organoid research and development.

Herein, we report a rare case of concurrent gastric and pulmonary mucosa-associated lymphoid tissue (MALT) lymphomas. A 65-year-old man who had been diagnosed with Helicobacter pylori-positive gastric MALT lymphoma received eradication therapy and achieved complete remission. During follow-up, he developed de novo pulmonary MALT lymphoma as a sequela of pulmonary tuberculosis, accompanied by recurrent gastric MALT lymphoma. Polymerase chain reaction (PCR) products of the CDR3 region of the immunoglobulin heavy chain gene showed an overall polyclonal pattern with bands at 400 base pairs (bp) and 200 bp predominant in the pulmonary tissue, as well as two distinctive bands in the gastric tissue at 400 bp and 200 bp. This case suggests that multiorgan lymphomas are more likely to be independent from each other when they are far apart, involve different organ systems, and have independent precipitating factors.
Aged ; Gastric Mucosa/pathology ; Humans ; Inflammation/pathology ; Lung Neoplasms/etiology/*pathology ; Lymphoma, B-Cell, Marginal Zone/etiology/*pathology ; Male ; Respiratory Mucosa/pathology ; Stomach Neoplasms/etiology/*pathology ; Tuberculosis, Pulmonary/complications

Herein, we report a rare case of concurrent gastric and pulmonary mucosa-associated lymphoid tissue (MALT) lymphomas. A 65-year-old man who had been diagnosed with Helicobacter pylori-positive gastric MALT lymphoma received eradication therapy and achieved complete remission. During follow-up, he developed de novo pulmonary MALT lymphoma as a sequela of pulmonary tuberculosis, accompanied by recurrent gastric MALT lymphoma. Polymerase chain reaction (PCR) products of the CDR3 region of the immunoglobulin heavy chain gene showed an overall polyclonal pattern with bands at 400 base pairs (bp) and 200 bp predominant in the pulmonary tissue, as well as two distinctive bands in the gastric tissue at 400 bp and 200 bp. This case suggests that multiorgan lymphomas are more likely to be independent from each other when they are far apart, involve different organ systems, and have independent precipitating factors.
Aged ; Gastric Mucosa/pathology ; Humans ; Inflammation/pathology ; Lung Neoplasms/etiology/*pathology ; Lymphoma, B-Cell, Marginal Zone/etiology/*pathology ; Male ; Respiratory Mucosa/pathology ; Stomach Neoplasms/etiology/*pathology ; Tuberculosis, Pulmonary/complications