Background: and Purpose This study was an open-label, dose-escalation, phase 1 clinical trial to determine the safety and dose of EN001 for patients with Duchenne muscular dystrophy (DMD). EN001, developed by ENCell, are allogeneic early-passage Wharton’s jelly-derived mesenchymal stem cells that originate at the umbilical cord, with preclinical studies demonstrating their high therapeutic efficacy for DMD. Methods: This phase 1 clinical trial explored the safety and tolerability of EN001 as a potential treatment option for patients with DMD. Six pediatric participants with DMD were divided into two subgroups of equal size: low-dose EN001 (5.0×105 cells/kg) and high-dose EN001 (2.5×106 cells/kg). All participants were monitored for 12 weeks after EN001 administration to assess its safety. Dose-limiting toxicity (DLT) was evaluated across 2 weeks post administration. Exploratory efficacy was evaluated by measuring serum creatine kinase levels, and functional evaluations—including spirometry, myometry, the North Star Ambulatory Assessment, and the 6-minute walk test—were conducted at week 12 and compared with the baseline values. Results: No participants experienced serious adverse events related to EN001 injection during the 12-week follow-up period. Mild adverse events included injection-related local erythema, edema, parosmia, and headache, but DLT was not observed. Functional evaluations at week 12 revealed no significant changes from baseline. Conclusions These results demonstrated that EN001 are safe and well tolerated for patients with DMD, and did not cause serious adverse events. The efficacy of EN001 could be confirmed through larger-scale future studies that incorporate repeated dosing and have a randomized controlled trial design.

Background: and Purpose This study was an open-label, dose-escalation, phase 1 clinical trial to determine the safety and dose of EN001 for patients with Duchenne muscular dystrophy (DMD). EN001, developed by ENCell, are allogeneic early-passage Wharton’s jelly-derived mesenchymal stem cells that originate at the umbilical cord, with preclinical studies demonstrating their high therapeutic efficacy for DMD. Methods: This phase 1 clinical trial explored the safety and tolerability of EN001 as a potential treatment option for patients with DMD. Six pediatric participants with DMD were divided into two subgroups of equal size: low-dose EN001 (5.0×105 cells/kg) and high-dose EN001 (2.5×106 cells/kg). All participants were monitored for 12 weeks after EN001 administration to assess its safety. Dose-limiting toxicity (DLT) was evaluated across 2 weeks post administration. Exploratory efficacy was evaluated by measuring serum creatine kinase levels, and functional evaluations—including spirometry, myometry, the North Star Ambulatory Assessment, and the 6-minute walk test—were conducted at week 12 and compared with the baseline values. Results: No participants experienced serious adverse events related to EN001 injection during the 12-week follow-up period. Mild adverse events included injection-related local erythema, edema, parosmia, and headache, but DLT was not observed. Functional evaluations at week 12 revealed no significant changes from baseline. Conclusions These results demonstrated that EN001 are safe and well tolerated for patients with DMD, and did not cause serious adverse events. The efficacy of EN001 could be confirmed through larger-scale future studies that incorporate repeated dosing and have a randomized controlled trial design.

Background: and Purpose This study was an open-label, dose-escalation, phase 1 clinical trial to determine the safety and dose of EN001 for patients with Duchenne muscular dystrophy (DMD). EN001, developed by ENCell, are allogeneic early-passage Wharton’s jelly-derived mesenchymal stem cells that originate at the umbilical cord, with preclinical studies demonstrating their high therapeutic efficacy for DMD. Methods: This phase 1 clinical trial explored the safety and tolerability of EN001 as a potential treatment option for patients with DMD. Six pediatric participants with DMD were divided into two subgroups of equal size: low-dose EN001 (5.0×105 cells/kg) and high-dose EN001 (2.5×106 cells/kg). All participants were monitored for 12 weeks after EN001 administration to assess its safety. Dose-limiting toxicity (DLT) was evaluated across 2 weeks post administration. Exploratory efficacy was evaluated by measuring serum creatine kinase levels, and functional evaluations—including spirometry, myometry, the North Star Ambulatory Assessment, and the 6-minute walk test—were conducted at week 12 and compared with the baseline values. Results: No participants experienced serious adverse events related to EN001 injection during the 12-week follow-up period. Mild adverse events included injection-related local erythema, edema, parosmia, and headache, but DLT was not observed. Functional evaluations at week 12 revealed no significant changes from baseline. Conclusions These results demonstrated that EN001 are safe and well tolerated for patients with DMD, and did not cause serious adverse events. The efficacy of EN001 could be confirmed through larger-scale future studies that incorporate repeated dosing and have a randomized controlled trial design.

BACKGROUND/OBJECTIVES: A dietary restriction on the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) has been reported to be effective in the treatment of gastrointestinal (GI) tract complications. Enteral nutrition (EN) is widely used for patients who cannot obtain their nutritional requirements orally, but many studies have reported EN complications, especially diarrhea, in up to 50% of patients. SUBJECTS/METHODS: We performed a single-center, non-randomized, controlled trial to determine the effects of a low-FODMAP enteral formula on GI complications in patients in intensive care units (ICUs). Patients in the ICU who needed EN (n = 66) were alternately assigned to the low-FODMAP group (n = 33) or the high-FODMAP group (n = 33). RESULTS: Anthropometric and biochemical parameters were measured, and stool assessment was performed using King's Stool Chart. We excluded patients who received laxatives, GI motility agents, proton pump inhibitors, antifungal agents, and antibiotics other than β-lactams. There were no differences in GI symptoms during 7 days of intervention, including bowel sound, abdominal distension, and vomiting between the 2 groups. However, diarrhea was more frequent in the high-FODMAP group (7/33 patients) than the lowFODMAP group (1/33 patients) (P = 0.044). CONCLUSIONS Our results suggest that a low-FODMAP enteral formula may be a practical therapeutic approach for patients who exhibit enteral formula complications. Our study warrants further randomized clinical trials and multicenter trials.

Chronic spontaneous urticaria (CSU) is defined as the occurrence of spontaneous wheals, angioedema, or both for >6 weeks in the absence of specific causes. It is a common condition associated with substantial disease burden both for affected individuals and societies in many countries, including Korea. CSU frequently persists for several years and requires high-intensity treatment; therefore, patients experience deteriorations in quality of life and medication-associated complications. During the last decade, there have been major advances in the pharmacological treatment of CSU and there is an outstanding need for evidence-based guidelines that reflect clinical practice in Korea. The guidelines reported here represent a joint initiative of the Korean Academy of Asthma, Allergy and Clinical Immunology and the Korean Dermatological Association, and aim to provide evidence-based guidance for the management of CSU in Korean adults and children. In Part 1, disease definition, guideline scope and development methodology as well as evidence-based recommendations on the use of antihistamines and corticosteroids are summarized.

Chronic spontaneous urticaria (CSU) is defined as the occurrence of spontaneous wheals, angioedema, or both for >6 weeks in the absence of specific causes. It is a common condition associated with substantial disease burden both for affected individuals and societies in many countries, including Korea. CSU frequently persists for several years and requires high-intensity treatment; therefore, patients experience deteriorations in quality of life and medication-associated complications. During the last decade, there have been major advances in the pharmacological treatment of CSU and there is an outstanding need for evidence-based guidelines that reflect clinical practice in Korea. The guidelines reported here represent a joint initiative of the Korean Academy of Asthma, Allergy and Clinical Immunology and the Korean Dermatological Association, and aim to provide evidence-based guidance for the management of CSU in Korean adults and children. In Part 1, disease definition, guideline scope and development methodology as well as evidence-based recommendations on the use of antihistamines and corticosteroids are summarized.

OBJECTIVE: This study examined the inflow and outflow patterns of emergency department patients with si-gun-gu in the Gwangju, Jeonbuk, and Jeonnam areas. METHODS: Data from the Gwangju, Jeonbuk, and Jeonnam were extracted from the National Emergency Department Information System in 2016. The extracted data (on 42 areas in Gwangju, Jeonbuk, and Jeonnam) using the variables of the patient's address (zip code) and the emergency medical institution code (emergency medical institution address) were used to calculate the relevance index and commitment index. The calculated indices were classified into the regional types by applying NbClust and cluster analysis (K-means) of the R package. RESULTS: The relevance indices ranged from 12.5% to 90.4%, and the commitment indices ranged from 9.2% to 90.3%. The results of cluster analysis with the relevance indices and commitment indices revealed three types for 39 areas. In cluster 1, the relevance indices ranged from 43.5% to 61.6%, and the commitment indices ranged from 9.2% to 49.5%. Three out of the thirty-nine areas were classified as the inflow type. In cluster 2, the relevance indices ranged from 12.5% to 56.0% and the commitment indices ranged from 62.5% to 90.3%; 12 areas were classified as the outflow type. The areas in cluster 3 were classified as the self-sufficient type, with relevance indices ranging from 60.1% to 90.4% and commitment indices ranging from 59.0% to 89.7% for 24 areas. CONCLUSION: Three area types and 11 out of 12 areas classified as outflow types were found to be emergency medical vulnerable areas. The results of this study can be used to establish local emergency medical policies.
Cluster Analysis ; Emergencies ; Emergency Service, Hospital ; Gwangju ; Humans ; Information Systems ; Jeollabuk-do ; Jeollanam-do

BACKGROUND: This study used the National Emergency Department Information System (NEDIS) data to analyze the flow of emergency and critical emergency patients and to identify the patterns of emergency medical service usage in Korea. METHODS: The relevance index (RI) and commitment index (CI) were calculated from the 2016 NEDIS data. In this study, the number of clusters was determined using NbClust, and cluster analysis was used to analyze the usage patterns of emergency and critical emergency patients. RESULTS: The RI and CI were calculated using 8,389,766 cases of 214 districts. The results of the RI and CI suggested that there were 3 types of clusters among the emergency patients. In Cluster 1, 54 districts (25.2%) had low RI and high CI, and it was of outflow type. Cluster 2 was categorized as the influx-type in 58 districts (27.1%) irrespective of RI and low CI. Cluster 3 was categorized as the self-sufficient type found in 102 districts (47.7%), with high RI and high CI. The cluster analysis of the critical emergency patients was divided into 2 types. Cluster 1 was categorized as outflow type with high CI found in 129 districts (60.3%), while Cluster 2 was categorized as inflow type with low CI found in 85 districts (39.7%). CONCLUSIONS This study elucidates the regional status of usage patterns of emergency and critical emergency patients in Korea. This study might serve as a basis for the establishment and selection of emergency medical service areas and vulnerable emergency medical service areas.
Cluster Analysis ; Emergency Medical Services ; Emergency Service, Hospital ; Humans ; Models, Theoretical ; Republic of Korea

Longjing Medial College(龍井醫科大學), established in Longjing, Yanbian, China on September 12, 1945, existed for about 1 year and 6 months until it was renamed as the Medical Department of Dongbei Junzheng Daxue Jilin Fenxiao(東北軍政大學吉林分校) in April 1947. However, there are only few records and studies on Longjing Medical College in Yanbian as well as in Korea. In order to fill the gap, this study attempted to restore the history of Longjing Medical College built in Yanbian, China immediately after the liberation. In particular, it analyzed how and why the Longjing Medical College was founded and operated, and which relations the college had with the post-war medical educational institutions, focusing on the ‘disconnection’ and ‘continuity’ in the historical sense. Since the establishment of Manchukuo(滿洲國), the Japanese colonial government had made it a major “frontier” and actively promoted the mass migration of Japanese and Koreans. For them, the government also set up three Exploitation Medical Schools in 1940. As a part of these three institutions, Longjing Exploitation Medical School(龍井開拓醫學院) educated more than 150 students by 1945, of which about one third was Korean. After the liberation, the Longjing Educational Alliance(龍井敎育同盟) decided to pursue the return-movement of the Longjing Exploitation Medical School and took over the institution. On September 12, 1945, Longjing Medical College opened at the school site of Longjing Exploitation Medical School. Longjing Medical College was founded by people who had ‘the perspective of Korean nationality’ in an atmosphere where the ‘ethnicity’ of the Koreans exercised considerable power. Nevertheless, in 1946, when the Chinese Civil War began and the Yanbian region became an important base of the Chinese Communist Party, the Party began to expand and strengthen their influences in the region. Accordingly, the operation rights of Longjing Medical College were transferred to the Yanbian Administrative offices of Supervision(延邊行政督察專員公署) and Government of Jirinsheng(吉林省政府) which were the administrative institution by the Chinese Communist Party in turns. In the end, Longjing Medical College was reorganized into the Medical Department of Dongbei Junzheng Daxue Jilin Fenxiao (1947. 3) and the first branch of the Chinese Medical College (1948. 1), a medical education institution focused on nurturing the medical personnel required for the Chinese Civil War. In January 1949, the first branch moved to Harbin, merged with the second branch there, and was transformed into Harbin Medical College. Afterwards, the Yanbian Koreans played a major role to establish Yanbian Medical College(延邊醫科專門學校) in a basis of the teachers and buildings left by the moving-out of the first branch(1948. 10. 1). Now, Yanbian Medical College is the official body of Yanbian University Medical Center. Longjing Medical College, which has such a complicated history, is partially ‘disconnected’ from the Yanbian medical educational institutions in the post-war era in terms of its possession, operation objective, and academic system. However, many of the early members of the Longjing Medical College were not only teachers and students of the Longjing Exploitation Medical School, but also a few of them continued to teach at the Medical Department of Dongbei Junzheng Daxue Jilin Fenxiao, the first branch of the Chinese Medical College, and Yanbian Medical College. Particularly, several members actively participated in the establishment of each school or in the position of the top leader of the school. Also, all the medical education institutions referred to above used the building and facilities of Longjing Exploitation Medical School until the period of Yanbian Medical College. As such, the history of Longjing Medical College as frontier history, gives us a difficult, but significant question on the meanings of ‘disconnection’ and ‘continuity’ in history and their implications.
Academic Medical Centers ; Asian Continental Ancestry Group ; Atmosphere ; China ; Education, Medical ; Humans ; Korea ; Schools, Medical

OBJECTIVE: We aimed to investigate possible associations between three norepinephrine transporter gene (SLC6A2) single nucleotide polymorphisms (T182C, A3081T, and G1287A) and schizophrenia. Also, we investigated the relationships of those polymorphisms with clinical severity and characteristics of schizophrenia. METHODS: Participants were 220 schizophrenia patients in the acute phase and 167 healthy controls. The genotype, allele frequency, and haplotype of each group were analyzed for T182C, A3081T, and G1287A polymorphisms. Of the 220 schizophrenia patients, 163 patients were evaluated with the Positive and Negative Syndrome Scale (PANSS) and the Korean version of the Calgary depression scale for schizophrenia (K-CDSS) at baseline. RESULTS: We found no significant differences between the schizophrenia patient group and the control group in genotype distribution or allele frequency of the three tested polymorphisms. Likewise, we could not find any significant differences in genotype or allele frequency by analyzing according to gender. In the haplotype study, no significant association emerged between specific haplotype combinations and schizophrenia. We also found no association between clinical scales (PANSS and K-CDSS) and the studied polymorphisms. CONCLUSION: Our results suggest that the investigated polymorphisms of the NET gene are not associated with susceptibility to schizophrenia or its clinical features in a Korean population. However, this study remains significant because it is the first haplotype study to investigate associations between NET gene (SLC6A2) single nucleotide polymorphisms and schizophrenia in a Korean population. Future research with a larger sample size and more genetic markers is needed to replicate our results.
Gene Frequency ; Genetic Markers ; Genotype ; Haplotypes ; Humans ; Norepinephrine Plasma Membrane Transport Proteins* ; Norepinephrine* ; Polymorphism, Single Nucleotide ; Sample Size ; Schizophrenia* ; Weights and Measures