Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Purpose: To report two cases of massive subretinal fluid accumulation at laser irradiated sites after photodynamic therapy in patients with age-related macular degeneration (ARMD).Case summary: (Case 1) A patient with bilateral polypoidal choroidal vasculopathy, who was treated with half-dose verteporfin photodynamic therapy (PDT), developed decreased visual acuity. On fundus examination, massive subretinal fluid accumulation was observed in the laser irradiated sites of both eyes. The subretinal fluid was reabsorbed without further treatment, and the patient's visual acuity has recovered. (Case 2) A patient with ARMD, accompanied by a choroidal neovascular membrane and accumulation of subretinal fluid in the right eye, developed decreased visual acuity on the treated eye a day after receiving half-dose PDT treatment. On fundus examination, the subretinal fluid in the right eye had increased more than 5-fold compared to pre-treatment levels. After one week, the amount of subretinal fluid decreased and the patient's visual acuity improved. However, since retinal exudate still remained, intravitreal bevacizumab treatment was administered. Thereafter, the patient’s fundus findings were unremarkable. Conclusions In the case of photodynamic therapy for ARMD, a large amount of subretinal fluid may occur as a rare complication. The subretinal fluid was naturally absorbed, but close observation is needed with the possibility of developing subretinal fluid in the event of decreased vision after photodynamic therapy.

Purpose: This study investigated the causative microorganisms, antibiotic susceptibility, and risk factors of infectious keratitis over the past 10 years. Methods: Data from patients with infectious keratitis who underwent microbial culture tests from 2012 to 2021, obtained from anonymized data systems, were analyzed. Microbial culture results and antibiotic susceptibility profiles were examined. A retrospective analysis of the medical records of patients with infectious keratitis during the same period was conducted to investigate the clinical characteristics and risk factors. Results: Data from 1,837 cases of infectious keratitis were extracted from anonymized records. The culture positive rate among patients was 46.0% (1,137/2,474), with coagulase-negative Staphylococcus (CoNS) being the most common causative organism (27.8%). Increased resistance to cefazolin and cefotaxime was observed in gram-negative bacteria, while there were no significant temporal changes in quinolone resistance in gram-positive or negative bacteria. A retrospective medical record analysis of 288 cases revealed that older patients, as well as those with an initial corrected visual acuity < 0.1, a history of ocular surgery, pre-existing ocular conditions, prior steroid eye drops, or glaucoma eye drops, had significantly higher rates of culture positivity. Multivariate analysis identified risk factors for severe keratitis requiring surgical intervention as a symptom-to-presentation period of 7 days or longer (p = 0.048) and pre-existing ocular conditions (p = 0.040). Conclusions CoNS was the most common microorganism causing infectious keratitis over the past decade. There has been an increase in resistance to cephalosporin antibiotics among gram-negative bacteria. Patients with pre-existing ocular conditions may require surgical intervention, so infectious keratitis in these patients requires greater attention.

Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background: s/Aims: The hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) is classified as the advanced stage (BCLC stage C) with extremely poor prognosis, and in current guidelines is recommended for systemic therapy. This study aimed to evaluate the surgical outcomes and long-term prognosis after hepatic resection (HR) for patients who have HCC combined with PVTT. Methods: We retrospectively analyzed 332 patients who underwent HR for HCC with PVTT at ten tertiary referral hospitals in South Korea. Results: The median overall and recurrence-free survival after HR were 32.4 and 8.6 months, while the 1-, 3-, and 5-year overall survival rates were 75%, 48%, and 39%, respectively. In multivariate analysis, tumor number, tumor size, AFP, PIVKA−II, neutrophil-to-lymphocyte ratio, and albumin–bilirubin (ALBI) grade were significant prognostic factors. The risk scoring was developed using these seven factors–tumor, inflammation and hepatic function (TIF), to predict patient prognosis. The prognosis of the patients was well stratified according to the scores (log-rank test, p < 0.001). Conclusions HR for patients who have HCC combined with PVTT provided favorable survival outcomes. The risk scoring was useful in predicting prognosis, and determining the appropriate treatment strategy for those patients who have HCC with PVTT.

Objectives: Although it is difficult to define the quality of stroke care, acute ischemic stroke (AIS) patients with moderate-to-severe neurological deficits may benefit from thrombectomy-capable hospitals (TCHs) that have a stroke unit, stroke specialists, and a substantial endovascular thrombectomy (EVT) case volume. Methods: From national audit data collected between 2013 and 2016, potential EVT candidates arriving within 24 hours with a baseline National Institutes of Health Stroke Scale score ≥6 were identified. Hospitals were classified as TCHs (≥15 EVT case/y, stroke unit, and stroke specialists), primary stroke hospitals (PSHs) without EVT (PSHs-without-EVT, 0 case/y), and PSHs-with-EVT. Thirty-day and 1-year case-fatality rates (CFRs) were analyzed using random intercept multilevel logistic regression. Results: Out of 35 004 AIS patients, 7954 (22.7%) EVT candidates were included in this study. The average 30-day CFR was 16.3% in PSHs-without-EVT, 14.8% in PSHs-with-EVT, and 11.0% in TCHs. The average 1-year CFR was 37.5% in PSHs-without-EVT, 31.3% in PSHs-with-EVT, and 26.2% in TCHs. In TCHs, a significant reduction was not found in the 30-day CFR (odds ratio [OR], 0.92; 95% confidence interval [CI], 0.76 to 1.12), but was found in the 1-year CFR (OR, 0.84; 95% CI, 0.73 to 0.96). Conclusions The 1-year CFR was significantly reduced when EVT candidates were treated at TCHs. TCHs are not defined based solely on the number of EVTs, but also based on the presence of a stroke unit and stroke specialists. This supports the need for TCH certification in Korea and suggests that annual EVT case volume could be used to qualify TCHs.

Objective: This study aimed to evaluate the oncologic outcomes according to disease burden in uterine cervical cancer patients with metachronous distant metastases. Methods: Between 2005 and 2015, 163 patients with metachronous distant metastases from uterine cervical cancer after receiving a definitive therapy were evaluated at seven institutions in Korea. Low metastatic burden was defined as less than 5 metastatic sites, whereas high metastatic burden was others. Each metastasis site was divided based on the lymph node (LN) and organs affected. The overall survival (OS) and progression-free survival (PFS) were assessed. Cox proportional hazards models, including other clinical variables, were used to evaluate the survival outcomes. Results: The median follow-up duration was 22.2 months (range: 0.3–174.8 months). Para-aortic LNs (56.4%), lungs (26.4%), supraclavicular LNs (18.4%), and peritoneum (13.5%) were found to be the common metastasis sites. Among 37 patients with a single metastasis, 17 (45.9%) had LN metastases and 20 (54.1%) had organ metastases. The 1- and 2-year OS rates were 73.9% and 55.0%, respectively, whereas the PFS rates were 67.2% and 42.9%, respectively. SCC Ag after recurrence and high metastatic burden were significant factors affecting the OS (p=0.004 and p<0.001, respectively). Distant organ recurrence, short disease-free interval (≤2 years), and high metastatic burden were unfavorable factors for PFS (p=0.003, p=0.011, and p=0.002, respectively). Conclusion A favorable oncologic outcome can be expected by performing salvage treatments in selected patients with a long disease-free interval, low metastatic burden, and/or lymphatic-only metastasis.

Background/Aims: We evaluated the feasibility and long-term efficacy of the combination of cytarabine, idarubicin, and all-trans retinoic acid (ATRA) for treating patients with newly diagnosed acute promyelocytic leukemia (APL). Methods: We included 87 patients with newly diagnosed acute myeloid leukemia and a t(15;17) or promyelocytic leukemia/retinoic acid receptor alpha (PML-RARα) mutation. Patients received 12 mg/m2/day idarubicin intravenously for 3 days and 100 mg/m2/day cytarabine for 7 days, plus 45 mg/m2/day ATRA. Clinical outcomes included complete remission (CR), relapse-free survival (RFS), overall survival (OS), and the secondary malignancy incidence during a 20-year follow-up. Results: The CR, 10-year RFS, and 10-year OS rates were 89.7%, 94.1%, and 73.8%, respectively, for all patients. The 10-year OS rate was 100% for patients that achieved CR. Subjects were classified according to the white blood cell (WBC) count in peripheral blood at diagnosis (low-risk, WBC < 10,000/mm3; high-risk, WBC ≥ 10,000/mm3). The low-risk group had significantly higher RFS and OS rates than the high-risk group, but the outcomes were not superior to the current standard treatment (arsenic trioxide plus ATRA). Toxicities were similar to those observed with anthracycline plus ATRA, and higher than those observed with arsenic trioxide plus ATRA. The secondary malignancy incidence after APL treatment was 2.7%, among the 75 patients that achieved CR, and 5.0% among the 40 patients that survived more than 5 years after the APL diagnosis. Conclusions Adding cytarabine to anthracycline plus ATRA was not inferior to anthracycline plus ATRA alone, but it was not comparable to arsenic trioxide plus ATRA. The probability of secondary malignancy was low.