1.Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study
Jie-Hyun KIM ; Hwoon-Yong JUNG ; In Kyung YOO ; Seon-Young PARK ; Jae Gyu KIM ; Jae Kyu SUNG ; Jin Seok JANG ; Gab Jin CHEON ; Kyoung Oh KIM ; Tae Oh KIM ; Soo Teik LEE ; Kwang Bum CHO ; Hoon Jai CHUN ; Jong-Jae PARK ; Moo In PARK ; Jae-Young JANG ; Seong Woo JEON ; Jin Woong CHO ; Dae Hwan KANG ; Gwang Ha KIM ; Jae J. KIM ; Sang Gyun KIM ; Nayoung KIM ; Yong Chan LEE ; Su Jin HONG ; Hyun-Soo KIM ; Sora LEE ; Sang Woo LEE
Gut and Liver 2024;18(1):70-76
Background/Aims:
H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA.However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis.
Methods:
A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.
Results:
According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.
Conclusions
DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
2.A Preliminary Study on the Potential Protective Role of the Antioxidative Stress Markers of Cognitive Impairment: Glutathione and Glutathione Reductase
Sang-a PARK ; Gihwan BYEON ; Jin Hyeong JHOO ; Hyung-Chun KIM ; Myoung-Nam LIM ; Jae-Won JANG ; Jong Bin BAE ; Ji Won HAN ; Tae Hui KIM ; Kyung Phil KWAK ; Bong Jo KIM ; Shin Gyeom KIM ; Jeong Lan KIM ; Seok Woo MOON ; Joon Hyuk PARK ; Seung-Ho RYU ; Jong Chul YOUN ; Dong Woo LEE ; Seok Bum LEE ; Jung Jae LEE ; Dong Young LEE ; Ki Woong KIM
Clinical Psychopharmacology and Neuroscience 2023;21(4):758-768
Objective:
To investigate the relationship between reduced glutathione (GSH), a key molecule of the antioxidant defense system in the blood, and glutathione reductase (GR), which reduces oxidized glutathione (glutathione disulfide [GSSG]) to GSH and maintains the redox balance, with the prevalence of Alzheimer’s dementia and cognitive decline.
Methods:
In all, 20 participants with Alzheimer’s dementia who completed the third follow-up clinical evaluation over 6 years were selected, and 20 participants with normal cognition were selected after age and sex matching. The GSH and GR concentrations were the independent variables. Clinical diagnosis and neurocognitive test scores were the dependent variables indicating cognitive status.
Results:
The higher the level of GR, the greater the possibility of having normal cognition than of developing Alzheimer’s dementia. Additionally, the higher the level of GR, the higher the neurocognitive test scores. However, this association was not significant for GSH. After 6 years, the conversion rate from normal cognition to cognitive impairment was significantly higher in the lower 50th percentile of the GR group than in the upper 50th percentile.
Conclusion
The higher the GR, the lower the prevalence of Alzheimer’s dementia and incidence of cognitive impairment and the higher the cognitive test scores. Therefore, GR is a potential protective biomarker against Alzheimer’s dementia and cognitive decline.
3.The Efficacy and Safety of a Human Perirenal Adipose TissueDerived Stromal Vascular Fraction in an Interstitial Cystitis Rat Model
Ji Yong HA ; Eun Hye LEE ; So Young CHUN ; Jun Nyung LEE ; Yun-Sok HA ; Jae-Wook CHUNG ; Bo Hyun YOON ; Minji JEON ; Hyun Tae KIM ; Tae Gyun KWON ; Eun Sang YOO ; Bum Soo KIM
Tissue Engineering and Regenerative Medicine 2023;20(2):225-237
BACKGROUND:
Interstitial cystitis (IC) is a chronic and intractable disease that can severely deteriorate patients’ quality of life. Recently, stem cell therapy has been introduced as a promising alternative treatment for IC in animal models. We aimed to verify the efficacy and safety of the human perirenal adipose tissue-derived stromal vascular fraction (SVF) in an IC rat model.
METHODS:
From eight-week-old female rats, an IC rat model was established by subcutaneous injection of 200 lg of uroplakin3A. The SVF was injected into the bladder submucosal layer of IC rats, and pain scale analysis, awakening cytometry, and histological and gene analyses of the bladder were performed. For the in vivo safety analysis, genomic DNA purification and histological analysis were also performed to check tumorigenicity and thrombus formation.
RESULTS:
The mean pain scores in the SVF 20 ll group were significantly lower on days 7 and 14 than those in the control group, and bladder intercontraction intervals were significantly improved in the SVF groups in a dose-dependent manner. Regeneration of the bladder epithelium, basement membrane, and lamina propria was observed in the SVF group.In the SVF groups, however, bladder fibrosis and the expression of inflammatory markers were not significantly improved compared to those in the control group.
CONCLUSION
This study demonstrated that a perirenal adipose tissue-derived SVF is a promising alternative for the management of IC in terms of improving bladder pain and overactivity.
4.Physical and biodegradable properties of 3D printed resorbable membranes for periodontal guided tissue regenerations
Hye-Bin GO ; Kyoung-Jin SEO ; Youn Wook CHUN ; Seung Won LEE ; Sung Min YOU ; Bum-Soon LIM ; Jae-Sung KWON
Korean Journal of Dental Materials 2021;48(2):89-98
The purpose of this study was to compare physical and biodegradable properties of 3D printed resorbable membranes that are used for guided tissue regenerations in periodontal tissues. Three types of 3D printed membranes (two types of non β-TCP and one type of β-TCP) were considered. The form and element compositions of 3D printed membranes were analyzed by field-emission scanning electron microscopy (FE-SEM) with energy-dispersive X-ray spectroscopy (EDS). Porosity and pore size were measured using Micro-CT. Also, tensile strength, biodegradability tests were performed. Statistical analyses were carried in tensile strength and cell viability test (p<0.05). The result of SEM images with EDS analyses showed linear layers of lattice structure with presence of C and O in all groups. There was a slight difference in Ca and P among some groups. Tensile strength was significantly different among all groups (p<0.05), and biodegradability showed that the group containing β-TCP resulted in the fastest degradation rate. Therefore, the results of this study concluded that the 3D printed resorbable membrane has variable physical and biodegradable properties for clinical use, where such information would be useful to be considered for the future development of related products and clinical application of the products.
5.Physical and biodegradable properties of 3D printed resorbable membranes for periodontal guided tissue regenerations
Hye-Bin GO ; Kyoung-Jin SEO ; Youn Wook CHUN ; Seung Won LEE ; Sung Min YOU ; Bum-Soon LIM ; Jae-Sung KWON
Korean Journal of Dental Materials 2021;48(2):89-98
The purpose of this study was to compare physical and biodegradable properties of 3D printed resorbable membranes that are used for guided tissue regenerations in periodontal tissues. Three types of 3D printed membranes (two types of non β-TCP and one type of β-TCP) were considered. The form and element compositions of 3D printed membranes were analyzed by field-emission scanning electron microscopy (FE-SEM) with energy-dispersive X-ray spectroscopy (EDS). Porosity and pore size were measured using Micro-CT. Also, tensile strength, biodegradability tests were performed. Statistical analyses were carried in tensile strength and cell viability test (p<0.05). The result of SEM images with EDS analyses showed linear layers of lattice structure with presence of C and O in all groups. There was a slight difference in Ca and P among some groups. Tensile strength was significantly different among all groups (p<0.05), and biodegradability showed that the group containing β-TCP resulted in the fastest degradation rate. Therefore, the results of this study concluded that the 3D printed resorbable membrane has variable physical and biodegradable properties for clinical use, where such information would be useful to be considered for the future development of related products and clinical application of the products.
6.Impact of Multiple Prostate Biopsies: Risk of Perioperative Complications and Biochemical Recurrence After Radical Prostatectomy
Kyong Min PARK ; Jae-Wook CHUNG ; Jun-Koo KANG ; Teak Jun SHIN ; Se Yun KWON ; Hyun Chan JANG ; Yun-Sok HA ; Seock Hwan CHOI ; Wonho JUNG ; Jun Nyung LEE ; Byung Hoon KIM ; Bum Soo KIM ; Hyun Tae KIM ; Jae Soo KIM ; Tae-Hwan KIM ; Eun Sang YOO ; Kyung Seop LEE ; Chun Il KIM ; Sung Kwang CHUNG ; Tae Gyun KWON
Korean Journal of Urological Oncology 2020;18(1):24-31
Purpose:
The aim of this study was to analyze the perioperative complications and oncological outcomes of radical prostatectomy (RP) in patients who underwent multiple prostate biopsies.
Materials and Methods:
A total of 1,112 patients who underwent RP between January 2009 and April 2016 at 4 different centers were included in this study. We divided these patients into 2 groups: patients who underwent only 1st biopsy, and those who underwent 2nd or more repeated biopsies. The association between the number of prior biopsies and perioperative complications and biochemical recurrence (BCR) was analyzed.
Results:
Of 1,112 patients, 1,046 patients (94.1%) underwent only 1st biopsy, and 66 (5.9%) underwent 2nd or more repeated biopsies. There were no significant differences in preoperative prostate-specific antigen levels, operation times, blood loss volumes, or hospital stay durations (all p>0.05). Patients who underwent multiple prostate biopsies presented with a localized tumor significantly more often (p<0.05). The Gleason score and rate of positive surgical margins were significantly lower in patients with multiple biopsies (all p<0.05). The Cox proportional hazards model analysis indicated that there was no association between the number of prior prostate biopsies and BCR (p>0.05). Kaplan-Meier curve analysis indicated that BCR-free survival rates between the 2 groups were similar (p>0.05).
Conclusions
Multiple prostate biopsies are not associated with an increased risk of perioperative complications, adverse pathological outcomes, or higher rates of BCR in patients who have undergone RP. (Korean J Urol Oncol 2020;18:24-31)
7.Bladder Regeneration Using a Polycaprolactone Scaffold with a Gradient Structure and Growth Factors in a Partially Cystectomized Rat Model
Ho Yong KIM ; So Young CHUN ; Eun Hye LEE ; Bomi KIM ; Yun-Sok HA ; Jae-Wook CHUNG ; Jun Nyung LEE ; Bum Soo KIM ; Se Heang OH ; Tae Gyun KWON
Journal of Korean Medical Science 2020;35(41):e374-
Background:
Tissue engineering can be used for bladder augmentation. However, conventional scaffolds result in fibrosis and graft shrinkage. This study applied an alternative polycaprolactone (PCL)-based scaffold (diameter = 5 mm) with a noble gradient structure and growth factors (GFs) (epidermal growth factor, vascular endothelial growth factor, and basic fibroblast growth factor) to enhance bladder tissue regeneration in a rat model.
Methods:
Partially excised urinary bladders of 5-week-old male Slc:SD rats were reconstructed with the scaffold (scaffold group) or the scaffold combined with GFs (GF group) and compared with sham-operated (control group) and untreated rats (partial cystectomy group). Evaluations of bladder volume, histology, immunohistochemistry (IHC), and molecular markers were performed at 4, 8, and 12 weeks after operation.
Results:
The bladder volumes of the scaffold and GF group recovered to the normal range, and those of the GF group showed more enhanced augmentation. Histological evaluations revealed that the GF group showed more organized urothelial lining, dense extracellular matrix, frequent angiogenesis, and enhanced smooth muscle bundle regeneration than the scaffold group. IHC for α-smooth muscle actin, pan-cytokeratin, α-bungarotoxin, and CD8 revealed that the GF group showed high formation of smooth muscle, blood vessel, urothelium, neuromuscular junction and low immunogenicity. Concordantly, real-time polymerase chain reaction experiments revealed that the GF group showed a higher expression of transcripts associated with smooth muscle and urothelial differentiation. In a 6-month in vivo safety analysis, the GF group showed normal histology.
Conclusion
This study showed that a PCL scaffold with a gradient structure incorporating GFs improved bladder regeneration functionally and histologically.
8.The Comparison of Seasonal Ginsenoside Composition Contents in Korean Wild Simulated Ginseng (Panax ginseng) which were Cultivated in Different Areas and Various Ages
Byung Wook YANG ; Jae Bum LEE ; Jung Min LEE ; Min Su JO ; Jae Kyung BYUN ; Hyoung Chun KIM ; Sung Kwon KO
Natural Product Sciences 2019;25(1):1-10
The ginsenoside content was compared with wild simulated ginseng (Panax ginseng) collected every season at 11 wild simulated ginseng plantations in Korea. As a result, the total saponin of 7 years old wild simulated ginseng showed the highest content of 4.5% in spring sampling wild simulated ginseng, 2.0% in summer sampling wild simulated ginseng, 1.2% in winter sampling wild simulated ginseng and 1.0% in autumn sampling wild simulated ginseng. And also, the total saponin of 10 years old wild simulated ginseng showed the highest content of 3.9% in spring sampling wild simulated ginseng, summer sampling wild simulated ginseng (1.8%), winter sampling wild simulated ginseng (1.6%) and autumn sampling wild simulated ginseng (0.6%). Therefore, the total saponin of spring sampling wild simulated ginseng was about 4.5 – 6.5 times higher than that of autumn sampling wild simulated ginseng regardless of cultivation period.
Korea
;
Panax
;
Saponins
;
Seasons
9.In Vivo Safety and Regeneration of Long-Term Transported Amniotic Fluid Stem Cells for Renal Regeneration
Na hee YU ; So Young CHUN ; Yun Sok HA ; Hyun Tae KIM ; Eugene LIH ; Dae Hwan KIM ; Jeongshik KIM ; Jae Wook CHUNG ; Phil Hyun SONG ; Eun Sang YOO ; Sung Kwang CHUNG ; Dong Keun HAN ; Bum Soo KIM ; Tae Gyun KWON
Tissue Engineering and Regenerative Medicine 2019;16(1):81-92
BACKGROUND: Despite major progress in stem cell therapy, our knowledge of the characteristics and tissue regeneration potency of long-term transported cells is insufficient. In a previous in vitro study, we established the optimal cell transport conditions for amniotic fluid stem cells (AFSCs). In the present study, the target tissue regeneration of long-term transported cells was validated in vivo. METHODS: For renal regeneration, transported AFSCs were seeded on a poly(lactide-co-glycolide) scaffold and implanted in a partially resected kidney. The target tissue regeneration of the transported cells was compared with that of freshly harvested cells in terms of morphological reconstruction, histological microstructure reformation, immune cell infiltration, presence of induced cells, migration into remote organs, expression of inflammation/fibrosis/renal differentiation-related factors, and functional recovery. RESULTS: The kidney implanted with transported cells showed recovery of total kidney volume, regeneration of glomerular/renal tubules, low CD4/CD8 infiltration, and no occurrence of cancer during 40 weeks of observation. The AFSCs gradually disappeared and did not migrate into the liver, lung, or spleen. We observed low expression levels of proinflammatory cytokines and fibrotic factors; enhanced expression of the genes Wnt4, Pax2, Wt1, and Emx2; and significantly reduced blood urea nitrogen and creatinine values. There were no statistical differences between the performance of freshly harvested cells and that of the transported cells. CONCLUSION: This study demonstrates that long-term transported cells under optimized conditions can be used for cell therapy without adverse effects on stem cell characteristics, in vivo safety, and tissue regeneration potency.
Amniotic Fluid
;
Blood Urea Nitrogen
;
Cell- and Tissue-Based Therapy
;
Creatinine
;
Cytokines
;
Female
;
In Vitro Techniques
;
Kidney
;
Liver
;
Lung
;
Polyglactin 910
;
Regeneration
;
Spleen
;
Stem Cells
10.Optimal Stem Cell Transporting Conditions to Maintain Cell Viability and Characteristics.
Na Hee YU ; So Young CHUN ; Yun Sok HA ; Hyun Tae KIM ; Dae Hwan KIM ; Jeongshik KIM ; Jae Wook CHUNG ; Jun Nyung LEE ; Phil Hyun SONG ; Eun Sang YOO ; Bum Soo KIM ; Tae Gyun KWON
Tissue Engineering and Regenerative Medicine 2018;15(5):639-647
BACKGROUND: The preservation of stem cell viability and characteristics during cell transport from the bench to patients can significantly affect the success of cell therapy. Factors such as suspending medium, time, temperature, cell density, and container type could be considered for transport conditions. METHODS: To establish optimal conditions, human amniotic fluid stem cells' (AFSCs) viabilities were analyzed under different media {DMEM(H), DMEM/F-12, K-SFM, RPMI 1640, α-MEM, DMEM(L), PBS or saline}, temperature (4, 22 or 37 ℃), cell density (1 × 10⁷ cells were suspended in 0.1, 0.5, 1.0 or 2.0 mL of medium) and container type (plastic syringe or glass bottle). After establishing the transport conditions, stem cell characteristics of AFSCs were compared to freshly prepared cells. RESULTS: Cells transported in DMEM(H) showed relatively higher viability than other media. The optimized transport temperature was 4 ℃, and available transport time was within 12 h. A lower cell density was associated with a better survival rate, and a syringe was selected as a transport container because of its clinical convenience. In compare of stem cell characteristics, the transported cells with established conditions showed similar potency as the freshly prepared cells. CONCLUSION: Our findings can provide a foundation to optimization of conditions for stem cell transport.
Amniotic Fluid
;
Cell Count
;
Cell Survival*
;
Cell- and Tissue-Based Therapy
;
Female
;
Glass
;
Humans
;
Stem Cells*
;
Survival Rate
;
Syringes

Result Analysis
Print
Save
E-mail