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: 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.

Purpose: Staphylococcus aureus can attach to extracellular matrix components and plasma proteins deposited on biomaterial surfaces, ultimately forming biofilms. Therefore, managing S. aureus is recommended for preventing and treating peri-implant diseases. This study aimed to evaluate the biofilm-forming ability of S. aureus on zirconia surfaces and to assess the efficacy of photodynamic therapy (PDT) in reducing these biofilms. Materials and Methods: Biofilm growth analysis showed optimal formation at 48 hours. Therefore, S. aureus ATCC 25923 was inoculated onto a sterilized zirconia disk and cultivated for 48 hours to form the biofilm. Thereafter, the biofilms were treated with phosphate-buffered saline (PBS; control), chlorhexidine (CHX), tetracycline (TC),toluidine blue O (TBO), cold diode laser (laser), or PDT (TBO + laser), with each group consisting of seven disks. The bacterial loadwas quantified using colony-forming unit (CFU) counts, and biofilm viability was evaluated using confocal laser scanning microscopy (CLSM). Results: Significant reductions in bacterial counts were observed in the CHX (95.3%), TC (95.0%), and PDT (93.8%) groups compared to the control (P < 0.001). CLSM revealed a greater number of dead bacteria in the CHX, TC and PDT groups compared to that in other groups. Conclusion Within its limitations, this study demonstrated that S. aureus can form biofilms on zirconia surfaces. PDT showed similar efficacy to conventional antimicrobial treatments such as CHX and TC for reducing S. aureus biofilms.zirconia

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: 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.

Purpose: Staphylococcus aureus can attach to extracellular matrix components and plasma proteins deposited on biomaterial surfaces, ultimately forming biofilms. Therefore, managing S. aureus is recommended for preventing and treating peri-implant diseases. This study aimed to evaluate the biofilm-forming ability of S. aureus on zirconia surfaces and to assess the efficacy of photodynamic therapy (PDT) in reducing these biofilms. Materials and Methods: Biofilm growth analysis showed optimal formation at 48 hours. Therefore, S. aureus ATCC 25923 was inoculated onto a sterilized zirconia disk and cultivated for 48 hours to form the biofilm. Thereafter, the biofilms were treated with phosphate-buffered saline (PBS; control), chlorhexidine (CHX), tetracycline (TC),toluidine blue O (TBO), cold diode laser (laser), or PDT (TBO + laser), with each group consisting of seven disks. The bacterial loadwas quantified using colony-forming unit (CFU) counts, and biofilm viability was evaluated using confocal laser scanning microscopy (CLSM). Results: Significant reductions in bacterial counts were observed in the CHX (95.3%), TC (95.0%), and PDT (93.8%) groups compared to the control (P < 0.001). CLSM revealed a greater number of dead bacteria in the CHX, TC and PDT groups compared to that in other groups. Conclusion Within its limitations, this study demonstrated that S. aureus can form biofilms on zirconia surfaces. PDT showed similar efficacy to conventional antimicrobial treatments such as CHX and TC for reducing S. aureus biofilms.zirconia

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: 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.

Purpose: Staphylococcus aureus can attach to extracellular matrix components and plasma proteins deposited on biomaterial surfaces, ultimately forming biofilms. Therefore, managing S. aureus is recommended for preventing and treating peri-implant diseases. This study aimed to evaluate the biofilm-forming ability of S. aureus on zirconia surfaces and to assess the efficacy of photodynamic therapy (PDT) in reducing these biofilms. Materials and Methods: Biofilm growth analysis showed optimal formation at 48 hours. Therefore, S. aureus ATCC 25923 was inoculated onto a sterilized zirconia disk and cultivated for 48 hours to form the biofilm. Thereafter, the biofilms were treated with phosphate-buffered saline (PBS; control), chlorhexidine (CHX), tetracycline (TC),toluidine blue O (TBO), cold diode laser (laser), or PDT (TBO + laser), with each group consisting of seven disks. The bacterial loadwas quantified using colony-forming unit (CFU) counts, and biofilm viability was evaluated using confocal laser scanning microscopy (CLSM). Results: Significant reductions in bacterial counts were observed in the CHX (95.3%), TC (95.0%), and PDT (93.8%) groups compared to the control (P < 0.001). CLSM revealed a greater number of dead bacteria in the CHX, TC and PDT groups compared to that in other groups. Conclusion Within its limitations, this study demonstrated that S. aureus can form biofilms on zirconia surfaces. PDT showed similar efficacy to conventional antimicrobial treatments such as CHX and TC for reducing S. aureus biofilms.zirconia