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.The Impact of Educational Interventions on Osteoporosis Knowledge among Korean Osteoporosis Patients.
Won Seok JO ; Eun Hee CHO ; Beon Jung KANG ; Gi Du KWON ; Yong Chan HA ; Sunmee JANG ; Ha Young KIM
Journal of Bone Metabolism 2018;25(2):115-121
BACKGROUND: The purpose of this study was to determine the impact of an educational intervention that includes information sharing about absolute fracture risk on the knowledge of osteoporosis and modifiable risk factors among Korean patients with osteoporosis. METHODS: Adults aged >50 years who visited the outpatient clinic for osteoporosis were recruited. Subjects with trauma-related fractures or pathological fractures were excluded. The anthropometric data and clinical risk factors for fracture were collected at baseline. The participants completed the survey questionnaire that measured their knowledge regarding osteoporosis at baseline and then received information about the risk of fracture and individual education. Fracture risk was classified into five groups according to degree. The post-survey was conducted 3 months later. The pretest results were compared with the posttest results. RESULTS: In this study, 179 subjects (15 men and 164 women) were enrolled. After the educational intervention, the mean osteoporosis knowledge score significantly increased from 10.6±5.7 at pre-education (baseline) to 11.7±6.3 at post-education (P < 0.001). When comparing the pre- and post-education Korean fracture risk scores, a negligible difference was found between the “very low risk” and “low risk” groups. However, the scores in the “very high risk” and “high risk” groups decreased from 77.6% to 76.0%. We found a difference over time only in physical activity. CONCLUSIONS: Simple educational intervention is effective in increasing osteoporosis knowledge among Korean patients with osteoporosis. It may confer some benefit by providing information about osteoporotic fracture risks to improve knowledge and awareness regarding osteoporosis.
Adult
;
Ambulatory Care Facilities
;
Education
;
Fractures, Spontaneous
;
Humans
;
Information Dissemination
;
Male
;
Motor Activity
;
Osteoporosis*
;
Osteoporotic Fractures
;
Risk Assessment
;
Risk Factors
8.Amyloidosis in a Whooper swan (Cygnus cygnus).
Sang Ho WOO ; Yong Ahn KIM ; Soo Whan KWON ; Yang Beom KIM ; Soong Hee YOUN ; Ki Yong SHIN ; Eun JUNG ; Du Min GO ; Dae Yong KIM
Korean Journal of Veterinary Research 2017;57(4):257-260
Two Whooper swan (Cygnus cygnus) died after suffering from pododermatitis, lethargy, and ataxia; necropsy was performed. Grossly, the liver was swollen and firm. The kidney and spleen were also enlarged and a pale tan color. On histopathologic examination with Congo red staining, amyloidosis was noted in liver, spleen, and kidney. In addition, marked osseous metaplasia was present in the liver. Based on these results, systemic amyloidosis involving liver, spleen, and kidney with osseous metaplasia in the liver was diagnosed. Study results indicate that an inflammatory reaction associated with pododermatitis had a role in the amyloidosis in this particular case.
Amyloidosis*
;
Ataxia
;
Congo Red
;
Kidney
;
Lethargy
;
Liver
;
Metaplasia
;
Spleen
;
Triacetoneamine-N-Oxyl
9.A Case of Thymic Carcinoma with Behcet's Disease Combined with Immunoglobulin A Nephropathy.
Se Hee PARK ; Jung Ho KIM ; Jung Yoen LEE ; Sug Kyun SHIN ; Yong Kook HONG ; Jeong Hae KIE ; Du Yong KANG ; Chan Hee LEE
Journal of Rheumatic Diseases 2015;22(2):118-122
Behcet's disease is a systemic inflammatory disorder of unknown etiology, characterized by recurrent oral aphthous ulcers, genital ulcers, uveitis, and skin lesions. Renal involvement is rare in patients with Behcet's disease particularly immunoglobulin A (IgA) nephropathy. Other autoimmune diseases have been associated with increased risk of malignancy, but not Behcet's disease. Some cases of Behcet's disease accompanied by bladder cancer, thyroid cancer, stomach cancer, or hematologic malignancies have been reported. However, to the best of our knowledge, co-occurrence of Behcet's diseases with thymic carcinoma has not yet been reported. We experienced a 49-year-old male patient who had been treated for Behcet disease and IgA nephropathy, who presented with a large mediastinal mass on chest x-ray. After thymectomy, he was diagnosed with thymic carcinoma with complete resection.
Autoimmune Diseases
;
Behcet Syndrome
;
Glomerulonephritis, IGA*
;
Hematologic Neoplasms
;
Humans
;
Immunoglobulin A
;
Male
;
Middle Aged
;
Skin
;
Stomach Neoplasms
;
Stomatitis, Aphthous
;
Thorax
;
Thymectomy
;
Thymoma*
;
Thyroid Neoplasms
;
Ulcer
;
Urinary Bladder Neoplasms
;
Uveitis
10.Efficacy of Slimming Cream Containing 3.5% Water-Soluble Caffeine and Xanthenes for the Treatment of Cellulite: Clinical Study and Literature Review.
Sang Young BYUN ; Soon Hyo KWON ; Su Hak HEO ; Jae Seong SHIM ; Mi Hee DU ; Jung Im NA
Annals of Dermatology 2015;27(3):243-249
BACKGROUND: Cellulite is a 'cottage cheese-like' cutaneous change caused by subcutaneous fat bulging into the dermis that usually leads to cosmetic problems. Slimming cream containing 3.5% water-soluble caffeine and xanthenes exhibits a lipolytic effect with penetration into the dermis. OBJECTIVE: To evaluate the efficacy and safety of slimming cream for the treatment of cellulite. METHODS: Fifteen subjects with cellulite applied slimming cream to the thighs and inner side of the upper arms twice daily for 6 weeks. Efficacy was assessed using a standard visual scale, changes in the circumferences of the thighs and upper arms, and patient satisfaction by a questionnaire at baseline, week 3, and week 6. Safety was assessed by inquiring about adverse events through questionnaires. RESULTS: The standard visual scale score improved significantly by 0.49 points (19.8%) at week 6. Thigh and upper-arm circumferences decreased by 0.7 cm (1.7%) and 0.8 cm (2.3%), respectively, at week 6. Slight itching and transient flushing were commonly reported, but no serious adverse event occurred. CONCLUSION: The slimming cream tested appears to be effective for the treatment of cellulitis without serious adverse effects. However, additional large clinical trials are required to confirm the efficacy and safety of slimming cream for the treatment of cellulitis.
Arm
;
Caffeine*
;
Cellulitis
;
Dermis
;
Flushing
;
Patient Satisfaction
;
Pruritus
;
Subcutaneous Fat
;
Thigh
;
Xanthenes*
;
Surveys and Questionnaires

Result Analysis
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