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.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. 
		                        		
		                        		
		                        		
		                        	
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.Clinical Practice Guideline for Postoperative Rehabilitation in Older Patients With Hip Fractures
Kyunghoon MIN ; Jaewon BEOM ; Bo Ryun KIM ; Sang Yoon LEE ; Goo Joo LEE ; Jung Hwan LEE ; Seung Yeol LEE ; Sun Jae WON ; Sangwoo AHN ; Heui Je BANG ; Yonghan CHA ; Min Cheol CHANG ; Jung-Yeon CHOI ; Jong Geol DO ; Kyung Hee DO ; Jae-Young HAN ; Il-Young JANG ; Youri JIN ; Dong Hwan KIM ; Du Hwan KIM ; In Jong KIM ; Myung Chul KIM ; Won KIM ; Yun Jung LEE ; In Seok LEE ; In-Sik LEE ; JungSoo LEE ; Chang-Hyung LEE ; Seong Hoon LIM ; Donghwi PARK ; Jung Hyun PARK ; Myungsook PARK ; Yongsoon PARK ; Ju Seok RYU ; Young Jin SONG ; Seoyon YANG ; Hee Seung YANG ; Ji Sung YOO ; Jun-il YOO ; Seung Don YOO ; Kyoung Hyo CHOI ; Jae-Young LIM
Annals of Rehabilitation Medicine 2021;45(3):225-259
		                        		
		                        			Objective:
		                        			The incidence of hip fractures is increasing worldwide with the aging population, causing a challenge to healthcare systems due to the associated morbidities and high risk of mortality. After hip fractures in frail geriatric patients, existing comorbidities worsen and new complications are prone to occur. Comprehensive rehabilitation is essential for promoting physical function recovery and minimizing complications, which can be achieved through a multidisciplinary approach. Recommendations are required to assist healthcare providers in making decisions on rehabilitation post-surgery. Clinical practice guidelines regarding rehabilitation (physical and occupational therapies) and management of comorbidities/complications in the postoperative phase of hip fractures have not been developed. This guideline aimed to provide evidence-based recommendations for various treatment items required for proper recovery after hip fracture surgeries. Methods Reflecting the complex perspectives associated with rehabilitation post-hip surgeries, 15 key questions (KQs) reflecting the complex perspectives associated with post-hip surgery rehabilitation were categorized into four areas: multidisciplinary, rehabilitation, community-care, and comorbidities/complications. Relevant literature from four databases (PubMed, EMBASE, Cochrane Library, and KoreaMed) was searched for articles published up to February 2020. The evidence level and recommended grade were determined according to the grade of recommendation assessment, development, and evaluation method. Results A multidisciplinary approach, progressive resistance exercises, and balance training are strongly recommended. Early ambulation, weigh-bearing exercises, activities of daily living training, community-level rehabilitation, management of comorbidities/complication prevention, and nutritional support were also suggested. This multidisciplinary approach reduced the total healthcare cost. 
		                        		
		                        			Conclusion
		                        			This guideline presents comprehensive recommendations for the rehabilitation of adult patients after hip fracture surgery.
		                        		
		                        		
		                        		
		                        	
6.Clinical Practice Guideline for Postoperative Rehabilitation in Older Patients With Hip Fractures
Kyunghoon MIN ; Jaewon BEOM ; Bo Ryun KIM ; Sang Yoon LEE ; Goo Joo LEE ; Jung Hwan LEE ; Seung Yeol LEE ; Sun Jae WON ; Sangwoo AHN ; Heui Je BANG ; Yonghan CHA ; Min Cheol CHANG ; Jung-Yeon CHOI ; Jong Geol DO ; Kyung Hee DO ; Jae-Young HAN ; Il-Young JANG ; Youri JIN ; Dong Hwan KIM ; Du Hwan KIM ; In Jong KIM ; Myung Chul KIM ; Won KIM ; Yun Jung LEE ; In Seok LEE ; In-Sik LEE ; JungSoo LEE ; Chang-Hyung LEE ; Seong Hoon LIM ; Donghwi PARK ; Jung Hyun PARK ; Myungsook PARK ; Yongsoon PARK ; Ju Seok RYU ; Young Jin SONG ; Seoyon YANG ; Hee Seung YANG ; Ji Sung YOO ; Jun-il YOO ; Seung Don YOO ; Kyoung Hyo CHOI ; Jae-Young LIM
Annals of Rehabilitation Medicine 2021;45(3):225-259
		                        		
		                        			Objective:
		                        			The incidence of hip fractures is increasing worldwide with the aging population, causing a challenge to healthcare systems due to the associated morbidities and high risk of mortality. After hip fractures in frail geriatric patients, existing comorbidities worsen and new complications are prone to occur. Comprehensive rehabilitation is essential for promoting physical function recovery and minimizing complications, which can be achieved through a multidisciplinary approach. Recommendations are required to assist healthcare providers in making decisions on rehabilitation post-surgery. Clinical practice guidelines regarding rehabilitation (physical and occupational therapies) and management of comorbidities/complications in the postoperative phase of hip fractures have not been developed. This guideline aimed to provide evidence-based recommendations for various treatment items required for proper recovery after hip fracture surgeries. Methods Reflecting the complex perspectives associated with rehabilitation post-hip surgeries, 15 key questions (KQs) reflecting the complex perspectives associated with post-hip surgery rehabilitation were categorized into four areas: multidisciplinary, rehabilitation, community-care, and comorbidities/complications. Relevant literature from four databases (PubMed, EMBASE, Cochrane Library, and KoreaMed) was searched for articles published up to February 2020. The evidence level and recommended grade were determined according to the grade of recommendation assessment, development, and evaluation method. Results A multidisciplinary approach, progressive resistance exercises, and balance training are strongly recommended. Early ambulation, weigh-bearing exercises, activities of daily living training, community-level rehabilitation, management of comorbidities/complication prevention, and nutritional support were also suggested. This multidisciplinary approach reduced the total healthcare cost. 
		                        		
		                        			Conclusion
		                        			This guideline presents comprehensive recommendations for the rehabilitation of adult patients after hip fracture surgery.
		                        		
		                        		
		                        		
		                        	
7.Is It Worth Treating Non-Bothering Nocturia? Results of a Multicenter Prospective Observational Study.
Kwangsung PARK ; Hyoung Keun PARK ; Sae Woong KIM ; Dae Yul YANG ; Jong Kwan PARK ; Hyun Jun PARK ; Ki Hak MOON ; Du Geon MOON ; Kweon Sik MIN ; Hwancheol SON ; Sung Won LEE ; Jae Seog HYUN ; Woo Suk CHOI ; Sang Kuk YANG
The World Journal of Men's Health 2018;36(3):248-254
		                        		
		                        			
		                        			PURPOSE: The purpose of this study was to evaluate the efficacy of treatment in patients with non-bothering nocturia. MATERIALS AND METHODS: In this prospective multicenter study, patients who visited hospitals for treatment of voiding symptoms were enrolled. Inclusion criteria were: 1) men >45 years, and 2) nocturia ≥2 confirmed by a three-day voiding diary. Subjects were divided into non-bothering and bothering groups based on International Consultation on Incontinence Questionnaire Nocturia (ICIQ-N) question 2b. Changes in voiding symptoms, frequency of nocturia, and bothersomeness were evaluated with international prostate symptom score (IPSS), ICIQ-N, and three-day voiding diary at 4 and 12 weeks after treatment. RESULTS: A total of 48 patients in the non-bothering nocturia group and 50 patients in the bothering nocturia group who completed the 12-week treatment were analyzed. The total IPSS was decreased by 5.8 in the non-bothering group and 5.2 in the bothering group. There was no significant difference in decrease of IPSS between the two groups. Both groups showed significant reduction in discomfort of nocturia. The ICIQ-N 2b score decreased from 3.9 to 2.7 (p=0.01) in the non-bothering group and from 6.9 to 4.6 (p=0.02) in the bothering group. The number of nocturia episodes was significantly decreased in both groups. CONCLUSIONS: Regardless of discomfort associated with nocturia, both groups showed significant improvement in nocturia-related discomfort and voiding symptoms. These results suggest that patients with nocturia who were unaware of its discomfort benefited from treatment.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Lower Urinary Tract Symptoms
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Nocturia*
		                        			;
		                        		
		                        			Observational Study*
		                        			;
		                        		
		                        			Prospective Studies*
		                        			;
		                        		
		                        			Prostate
		                        			;
		                        		
		                        			Prostatic Hyperplasia
		                        			
		                        		
		                        	
8.Isolation and characterization of Korean porcine deltacoronavirus strain KNU16-07
Guehwan JANG ; Seong Hee KIM ; Yoo Jin LEE ; Seungjoon KIM ; Du Sik LEE ; Kyoung Ki LEE ; Changhee LEE
Journal of Veterinary Science 2018;19(4):577-581
		                        		
		                        			
		                        			Porcine deltacoronavirus (PDCoV) has emerged in several pig-raising countries and has been a causative pathogen associated with diarrheal diseases in South Korea since 2014. In the present study, we were able to isolate and cultivate a Korean PDCoV strain (KNU16-07) in cell culture and investigate its pathogenicity. PDCoV-inoculated piglets showed watery diarrhea accompanied by acute enteritis in the natural host. Sequencing analysis demonstrated the genetic stability of KNU16-07 for at least thirty serial passages.
		                        		
		                        		
		                        		
		                        			Cell Culture Techniques
		                        			;
		                        		
		                        			Diarrhea
		                        			;
		                        		
		                        			Enteritis
		                        			;
		                        		
		                        			Korea
		                        			;
		                        		
		                        			Serial Passage
		                        			;
		                        		
		                        			Virulence
		                        			
		                        		
		                        	
9.Quality of Life and Physical Ability Changes After Hospital-Based Cardiac Rehabilitation in Patients With Myocardial Infarction.
Byung Joo LEE ; Jin Young GO ; Ae Ryung KIM ; Seong Min CHUN ; Minhyuk PARK ; Dong Heon YANG ; Hun Sik PARK ; Tae Du JUNG
Annals of Rehabilitation Medicine 2017;41(1):121-128
		                        		
		                        			
		                        			OBJECTIVE: To evaluate the effect of hospital-based cardiac rehabilitation (CR) on quality of life (QOL) and physical ability in patients with myocardial infarction (MI). METHODS: Patients with MI who were referred to the Cardiac Health and Rehabilitation Center 2 weeks after percutaneous coronary intervention were divided into CR and non-CR groups. The CR group performed supervised exercises 3 times a week for 2 months. QOL assessment, using the 36-item Short-Form Health Survey (SF-36) and physical ability evaluation were performed at the beginning and end of CR. RESULTS: The CR group demonstrated statistically significant improvements in physical functioning (PF), physical role functioning (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social role functioning (SF), emotional role functioning (RE), mental health (MH), physical component summary (PCS), and mental component summary (MCS). The non-CR group showed improvement in RP. Secondary outcomes, including resting heart rate (RHR), maximal oxygen consumption (VO(2max)), metabolic equivalent of task (MET), maximal exercise time (ET(max)), stage 3 Borg rating of perceived exertion (3RPE), maximal Borg rating of perceived exertion (RPEmax), and stage 3 rate pressure product (3RPP), improved in the CR group. The non-CR group showed improvements in VO(2max), MET, ET(max), and 3RPE. There were significant differences in improvements in PF, RP, BP, VT, SF, MH, MCS, RHR, VO(2max), MET, ET(max), 3RPE, and 3RPP between the two groups. CONCLUSION: Male patients with MI demonstrated improvements in QOL and physical ability following hospital-based CR; the impact on the mental component was greater than that on the physical component.
		                        		
		                        		
		                        		
		                        			Exercise
		                        			;
		                        		
		                        			Health Surveys
		                        			;
		                        		
		                        			Heart Rate
		                        			;
		                        		
		                        			Home Care Services, Hospital-Based
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Mental Health
		                        			;
		                        		
		                        			Metabolic Equivalent
		                        			;
		                        		
		                        			Myocardial Infarction*
		                        			;
		                        		
		                        			Oxygen Consumption
		                        			;
		                        		
		                        			Percutaneous Coronary Intervention
		                        			;
		                        		
		                        			Physical Fitness
		                        			;
		                        		
		                        			Quality of Life*
		                        			;
		                        		
		                        			Rehabilitation Centers
		                        			;
		                        		
		                        			Rehabilitation*
		                        			
		                        		
		                        	
10.Reactive Oxygen Species are Involved in Y-27632-induced Neurite Outgrowth in PC12 Cells.
So Yeong PARK ; Seong Ah MOON ; Jeong Mi AN ; Du sik KIM ; Jeong Taeg SEO
International Journal of Oral Biology 2016;41(4):231-236
		                        		
		                        			
		                        			Inhibition of Rho-associated coiled coil-containing kinase (ROCK) has been reported to promote differentiation of neuronal cells. Here, we examined the effect of Y-27632, a ROCK inhibitor, on the outgrowth of neurites in PC12 cells. Y-27632 caused a rapid induction of neurite outgrowth in PC12 cells in a time-dependent manner. The neurite outgrowth, triggered by Y-27632, was accompanied by Rac1 activation, and was attenuated by Rac1 inhibitor NSC23766, in a concentration-dependent manner. Y-27632 also induced an increase in the production of reactive oxygen species (ROS). Pretreatment with N-acetylcysteine, an ROS scavenger, inhibited the ROS generation and neurite outgrowth in response to Y-27632. These results indicate that the activation of Rac1 and the generation of ROS contribute to the neurite outgrowth triggered by Y-27632 in PC12 cells.
		                        		
		                        		
		                        		
		                        			Acetylcysteine
		                        			;
		                        		
		                        			Animals
		                        			;
		                        		
		                        			Neurites*
		                        			;
		                        		
		                        			Neurons
		                        			;
		                        		
		                        			PC12 Cells*
		                        			;
		                        		
		                        			Phosphotransferases
		                        			;
		                        		
		                        			Reactive Oxygen Species*
		                        			
		                        		
		                        	
            
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