1.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
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.
2.Antimicrobial effect of infrared diode laser utilizing indocyanine green against Staphylococcus aureus biofilm on titanium surface
Seung Gi KIM ; Si-Young LEE ; Jong-Bin LEE ; Heung-Sik UM ; Jae-Kwan LEE
Journal of Dental Rehabilitation and Applied Science 2024;40(2):55-63
Purpose:
This study aimed to assess the antimicrobial efficacy of an 810-nm infrared diode laser with indocyanine green (ICG) against Staphylococcus aureus on sandblasted, large grit, and acid-etched (SLA) titanium surfaces, comparing its effectiveness with alternative chemical decontamination modalities.
Materials and Methods:
Biofilms of S. aureus ATCC 25923 were culturedon SLA titanium disks for 48 hours. The biofilms were divided into five treatment groups: control, chlorhexidine gluconate (CHX), tetracycline (TC), ICG, and 810-nm infrared diode laser with ICG (ICG-PDT). After treatment, colony-forming units were quantified to assess surviving bacteria, and viability was confirmed through confocal laser-scanning microscope (CLSM) imaging.
Results:
All treated groups exhibited a statistically significant reduction in S. aureus (P < 0.05), with notable efficacy in the CHX, TC, and ICG-PDT groups (P < 0.01). While no statistical difference was observed between TC and CHX, the ICG-PDT group demonstrated superior bacterial reduction. CLSM images revealed a higher proportion of dead bacteria stained in red within the ICG-PDT groups.
Conclusion
Within the limitations, ICG-PDT effectively reduced S. aureus biofilms on SLA titanium surfaces. Further investigations into alternative decontamination methods and the clinical impact of ICG-PDT on peri-implant diseases are warranted.
3.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
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.
4.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
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.
5.Antimicrobial effect of infrared diode laser utilizing indocyanine green against Staphylococcus aureus biofilm on titanium surface
Seung Gi KIM ; Si-Young LEE ; Jong-Bin LEE ; Heung-Sik UM ; Jae-Kwan LEE
Journal of Dental Rehabilitation and Applied Science 2024;40(2):55-63
Purpose:
This study aimed to assess the antimicrobial efficacy of an 810-nm infrared diode laser with indocyanine green (ICG) against Staphylococcus aureus on sandblasted, large grit, and acid-etched (SLA) titanium surfaces, comparing its effectiveness with alternative chemical decontamination modalities.
Materials and Methods:
Biofilms of S. aureus ATCC 25923 were culturedon SLA titanium disks for 48 hours. The biofilms were divided into five treatment groups: control, chlorhexidine gluconate (CHX), tetracycline (TC), ICG, and 810-nm infrared diode laser with ICG (ICG-PDT). After treatment, colony-forming units were quantified to assess surviving bacteria, and viability was confirmed through confocal laser-scanning microscope (CLSM) imaging.
Results:
All treated groups exhibited a statistically significant reduction in S. aureus (P < 0.05), with notable efficacy in the CHX, TC, and ICG-PDT groups (P < 0.01). While no statistical difference was observed between TC and CHX, the ICG-PDT group demonstrated superior bacterial reduction. CLSM images revealed a higher proportion of dead bacteria stained in red within the ICG-PDT groups.
Conclusion
Within the limitations, ICG-PDT effectively reduced S. aureus biofilms on SLA titanium surfaces. Further investigations into alternative decontamination methods and the clinical impact of ICG-PDT on peri-implant diseases are warranted.
6.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
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.
7.Antimicrobial effect of infrared diode laser utilizing indocyanine green against Staphylococcus aureus biofilm on titanium surface
Seung Gi KIM ; Si-Young LEE ; Jong-Bin LEE ; Heung-Sik UM ; Jae-Kwan LEE
Journal of Dental Rehabilitation and Applied Science 2024;40(2):55-63
Purpose:
This study aimed to assess the antimicrobial efficacy of an 810-nm infrared diode laser with indocyanine green (ICG) against Staphylococcus aureus on sandblasted, large grit, and acid-etched (SLA) titanium surfaces, comparing its effectiveness with alternative chemical decontamination modalities.
Materials and Methods:
Biofilms of S. aureus ATCC 25923 were culturedon SLA titanium disks for 48 hours. The biofilms were divided into five treatment groups: control, chlorhexidine gluconate (CHX), tetracycline (TC), ICG, and 810-nm infrared diode laser with ICG (ICG-PDT). After treatment, colony-forming units were quantified to assess surviving bacteria, and viability was confirmed through confocal laser-scanning microscope (CLSM) imaging.
Results:
All treated groups exhibited a statistically significant reduction in S. aureus (P < 0.05), with notable efficacy in the CHX, TC, and ICG-PDT groups (P < 0.01). While no statistical difference was observed between TC and CHX, the ICG-PDT group demonstrated superior bacterial reduction. CLSM images revealed a higher proportion of dead bacteria stained in red within the ICG-PDT groups.
Conclusion
Within the limitations, ICG-PDT effectively reduced S. aureus biofilms on SLA titanium surfaces. Further investigations into alternative decontamination methods and the clinical impact of ICG-PDT on peri-implant diseases are warranted.
8.Optimizing the Efficacy of Electroconvulsive Therapy
Eun Jeong JOO ; Kyu Young LEE ; Hyoseok KANG ; Heung Sik KIM ; Yong Sik KIM ; In Won CHUNG
Journal of Korean Neuropsychiatric Association 2023;62(4):135-156
Modern electroconvulsive therapy (ECT) is a non-pharmacological and biological treatment that is clinically effective and safe. ECT is used in the treatment of many psychiatric disorders, some neurological diseases, and psychiatric emergencies requiring a rapid and life-saving clinical response. Generalized seizures of the central nervous system induced by the electrical stimulation of ECT are an essential component of the therapeutic effects, which are attributed to the various neuronal responses of the brain. Modern ECT is conducted under general anesthesia, given to the extent of loss of consciousness, followed by administration of a muscle relaxant, and ECT with minimally appropriate electrical stimulation. ECT optimization has the main objective of ensuring maximum clinical efficacy and safety with minimal adverse events through adequate generalized seizures. Since its first introduction in clinical practice in 1938, many studies have been carried out and advances made to enhance the therapeutic effects of ECT and address the adverse events associated with it. As a result, there have been developments such as the use of a square wave instead of a sine wave, various electrode placements, dose titration methods, seizure thresholds, general anesthesia with muscle relaxation, session scheduling, monitoring of electroencephalograms (EEG) and electromyograms, etc. and these have been applied to actual clinical practice. Research on the clinical characteristics and the optimal ECT parameters to increase the efficacy of seizures is still ongoing. In this review, various factors associated with ECT such as EEG monitoring, motor seizures, electrode placements, stimulation dose and titration, seizure evaluation and adequacy, and the ECT algorithms are discussed to improve the efficacy of modern ECT as a useful treatment for psychiatric disorders.
9.COVID-19 in a 16-Year-Old Adolescent With Mucopolysaccharidosis Type II:Case Report and Review of Literature
So Yun PARK ; Heung Sik KIM ; Mi Ae CHU ; Myeong-Hee CHUNG ; Seokjin KANG
Pediatric Infection & Vaccine 2022;29(2):70-76
Coronavirus disease 2019 (COVID-19) in patients with underlying diseases, is associated with high infection and mortality rates, which may result in acute respiratory distress syndrome and death. Mucopolysaccharidosis (MPS) type II is a progressive metabolic disorder that stems from cellular accumulation of the glycosaminoglycans, heparan, and dermatan sulfate. Upper and lower airway obstruction and restrictive pulmonary diseases are common complaints of patients with MPS, and respiratory infections of bacterial or viral origin could result in fatal outcomes. We report a case of COVID-19 in a 16-year-old adolescent with MPS type II, who had been treated with idursulfase since 5 years of age. Prior to infection, the patient’s clinical history included developmental delays, abdominal distension, snoring, and facial dysmorphism. His primary complaints at the time of admission included rhinorrhea, cough, and sputum without fever or increased oxygen demand. His heart rate, respiratory rate, and oxygen saturation were within the normal biological reference intervals, and chest radiography revealed no signs of pneumonia. Consequently, supportive therapy and quarantine were recommended. The patient experienced an uneventful course of COVID-19 despite underlying MPS type II, which may be the result of an unfavorable host cell environment and changes in expression patterns of proteins involved in interactions with viral proteins. Moreover, elevated serum heparan sulfate in patients with MPS may compete with cell surface heparan sulfate, which is essential for successful interaction between the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein and the host cell surface, thereby protecting against intracellular penetration by SARS-CoV-2.
10.Pathophysiological Role of TLR4 in Chronic Relapsing Itch Induced by Subcutaneous Capsaicin Injection in Neonatal Rats
Hee Joo KIM ; Eun-Hui LEE ; Yoon Hee LIM ; Dongil JEONG ; Heung Sik NA ; YunJae JUNG
Immune Network 2022;22(2):e20-
Despite the high prevalence of chronic dermatitis and the accompanied intractable itch, therapeutics that specifically target itching have low efficacy. Increasing evidence suggests that TLRs contribute to immune activation and neural sensitization; however, their roles in chronic itch remain elusive. Here, we show that the RBL-2H3 mast cell line expresses TLR4 and that treatment with a TLR4 antagonist opposes the LPS dependent increase in mRNA levels of Th2 and innate cytokines. The pathological role of TLR4 activation in itching was studied in neonate rats that developed chronic itch due to neuronal damage after receiving subcutaneous capsaicin injections. Treatment with a TLR4 antagonist protected these rats with chronic itch against scratching behavior and chronic dermatitis.TLR4 antagonist treatment also restored the density of cutaneous nerve fibers and inhibited the histopathological changes that are associated with mast cell activation after capsaicin injection. Additionally, the expression of IL-1β, IL-4, IL-5, IL-10, and IL-13 mRNA in the lesional skin decreased after TLR4 antagonist treatment. Based on these data, we propose that inhibiting TLR4 alleviated itch in a rat model of chronic relapsing itch, and the reduction in the itch was associated with TLR4 signaling in mast cells and nerve fibers.

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