• Title/Summary/Keyword: human clinical trial

Search Result 189, Processing Time 0.031 seconds

A Potent Tyrosinase Inhibitor from Artocarpus Lakoocha Heartwood Extract: Comparative Evaluation of Its Melanin- Reducing Efficacy in Guinea Pigs and Humans

  • Tengamnuay, Parkpoom;Pengrungruangwong, Kumkwan;Likhitwitayawuid, Kittisak
    • Proceedings of the SCSK Conference
    • /
    • 2003.09b
    • /
    • pp.201-212
    • /
    • 2003
  • The heartwood extract of Artocarpus lakoocha Roxb., which contains a potent tyrosinase inhibitor oxyresveratrol, was evaluated for its melanin-reducing efficacy in both guinea pigs and human volunteers. After 4 week-daily application of the extract dissolved in propylene glycol to the back of guinea pigs, significant reduction in melanin content was detected, with the effect greater than 3% kojic acid and solvent propylene glycol (P < 0.05). The extract was subsequently tested in female volunteers (3 groups of 20 subjects) using a parallel clinical trial with self-control. The first group received the A. lakoocha solution in propylene glycol whereas the second and the third group respectively received 0.25% licorice extract and 3% kojic acid in the same solvent. The subject in each group twice daily applied the test solution on one arm whereas the remaining arm was applied with only propylene glycol (self-control) for 12 weeks. The A. lakoocha extract was found to be the most effective agent, giving the shortest onset of significant whitening after only 4 weeks of application (P < 0.05), followed by 3% kojic acid (8 weeks) and 0.25% licorice extract (10 weeks). The whitening effect also increased with time, with the highest extent observed with A. lakoocha at week 12. The in vitro antityrosinase activity of A. lakoocha extract decreased with time upon storage at room temperature but could be stabilized by a combination of several antioxidants. In conclusion, the heartwood extract of A. lakoocha appeared to have promising potential for use as an effective and economical skin-whitening agent.

  • PDF

Critical Care Medicine (호흡기내과 의사를 위한 Respiratory Review of 2010)

  • Park, Jie-Hae;Chae, Jin-Nyeong;Choi, Won-Il
    • Tuberculosis and Respiratory Diseases
    • /
    • v.69 no.2
    • /
    • pp.75-80
    • /
    • 2010
  • The year of 2009~2010 brought a number of concepts and new ideas were evaluated with promising results. However, some studies that challenged many beliefs. In acute respiratory distress syndrome (ARDS), recent clinical studies took into consideration of pathophysiologic changes of respiratory system compliance. Meta-analysis of positive end-expiratory pressure trials showed survival benefit of high positive end-expiratory pressure in ARDS. Until now, prone positioning did not show survival benefit in patients with ARDS. Extracorporeal membrane oxygenation (ECMO) based management improved survival in patients with severe ARDS. ECMO can be a management option in severe ARDS. Sedation is a standard practice in critically ill patients needing mechanical ventilation. However, Danish group reported less sedation of critically ill patients receiving mechanical ventilation was associated with an increase in days without ventilation. Although this single center study has some limitations, the overall results are promising. Use of maximal sterile barrier precautions (mask, sterile gown, sterile gloves, and large sterile drapes) with chlorhexidine-impregnated dressing reduced central venous catheter related infection. Selective oropharyngeal decontamination (application of topical antibiotics in the oropharynx) reduced the mortality rate of an intensive care unit (ICU) population. Normoglycemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE-SUGAR) trial reported intensive glucose control increased mortality among adults in the ICU. Some of the results of above papers are promising. However, some ideas may need for more frequent individual assessment and increase the workload of ICU staffs. Before implementation of new practice in ICU, we should take into consideration of individual hospital situation including human and material resources.

Recent Progress in Immunotherapy for Gastric Cancer

  • Jeesun Yoon;Tae-Yong Kim;Do-Youn Oh
    • Journal of Gastric Cancer
    • /
    • v.23 no.1
    • /
    • pp.207-223
    • /
    • 2023
  • Gastric cancer (GC) is the fourth leading cause of cancer-related deaths worldwide. Under the standard of care, patients with advanced GC (AGC) have a median survival time of approximately 12-15 months. With the emergence of immunotherapy as a key therapeutic strategy in medical oncology, relevant changes are expected in the systemic treatment of GC. In the phase III ATTRACTION-2 trial, nivolumab, a monoclonal anti-programmed cell death 1 (PD-1) antibody, as a third- or later-line treatment improved overall survival (OS) compared with placebo in patients with AGC. Furthermore, nivolumab in combination with 5-fluorouracil and platinum as a first-line treatment improved OS in patients with human epidermal growth factor receptor-2 (HER2)-negative AGC in the global phase III CheckMate-649 study. Another anti-PD-1 antibody, pembrolizumab, in combination with trastuzumab and cytotoxic chemotherapy as a first-line treatment, significantly improved the overall response rate in patients with HER2-positive AGC. Therefore, immune checkpoint inhibitors (ICIs) are essential components of the current treatment of GC. Subsequent treatments after ICI combination therapy, such as ICI rechallenge or combination therapy with agents having other modes of action, are being actively investigated to date. On the basis of the success of immunotherapy in the treatment of AGC, various clinical trials are underway to apply this therapeutic strategy in the perioperative and postoperative settings for patients with early GC. This review describes recent progress in immunotherapy and potential immunotherapy biomarkers for GC.

Breakthroughs in the Systemic Treatment of HER2-Positive Advanced/Metastatic Gastric Cancer: From Singlet Chemotherapy to Triple Combination

  • Sun Young Rha;Hyun Cheol Chung
    • Journal of Gastric Cancer
    • /
    • v.23 no.1
    • /
    • pp.224-249
    • /
    • 2023
  • Gastric cancer is heterogeneous in morphology, biology, genomics, and treatment response. Alterations in human epidermal growth factor receptor 2 (HER2) overexpression, microsatellite instability (MSI) status, programmed death-ligand 1 (PD-L1) levels, and fibroblast growth factor receptor 2 (FGFR2) can be used as biomarkers. Since the combination of fluoropyrimidine/platinum plus trastuzumab that was investigated in the ToGA trial was approved as a standard of care in HER2-positive patients in 2010, no other agents showed efficacy in the first- (HELOISE, LOGiC, JACOB trials) and second- (TyTAN, GATSBY, T-ACT trials) line treatments. Despite the success in treating breast cancer, various anti-HER2 agents, including a monoclonal antibody (pertuzumab), an antibody-drug conjugate (ADC; trastuzumab emtansine [T-DM1]), and a small molecule (lapatinib) failed to translate into clinical benefits until the KEYNOTE-811 (first-line) and DESTINY-Gastri01 (≥second-line) trials were conducted. The incorporation of HER2-directed treatment with immune checkpoint inhibitors in the form of a monoclonal antibody or ADC is now approved as a standard treatment. Despite the promising results of new agents (engineered monoclonal antibodies, bi-specific antibodies, fusion proteins, and small molecules) in the early phase of development, the management of HER2-positive gastric cancer requires further optimization to achieve precision medicine with a chemotherapeutic backbone. Treatment resistance is a complex process that can be overcome using a combination of chemotherapy, targeted agents, and immune checkpoint inhibitors, including novel agents. HER2 status must be reassessed in patients undergoing anti-HER2 treatment with disease progression after the first-line treatment. As a general guideline, patients who need systemic treatment should receive chemotherapy plus targeted agents, anti-angiogenic agents, immune checkpoint inhibitors, or their combinations.

Cryopreservation of mesenchymal stem cells derived from dental pulp: a systematic review

  • Sabrina Moreira Paes;Yasmine Mendes Pupo;Bruno Cavalini Cavenago;Thiago Fonseca-Silva;Carolina Carvalho de Oliveira Santos
    • Restorative Dentistry and Endodontics
    • /
    • v.46 no.2
    • /
    • pp.26.1-26.15
    • /
    • 2021
  • Objectives: The aim of the present systematic review was to investigate the cryopreservation process of dental pulp mesenchymal stromal cells and whether cryopreservation is effective in promoting cell viability and recovery. Materials and Methods: This systematic review was developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and the research question was determined using the population, exposure, comparison, and outcomes strategy. Electronic searches were conducted in the PubMed, Cochrane Library, Science Direct, LILACS, and SciELO databases and in the gray literature (dissertations and thesis databases and Google Scholar) for relevant articles published up to March 2019. Clinical trial studies performed with dental pulp of human permanent or primary teeth, containing concrete information regarding the cryopreservation stages, and with cryopreservation performed for a period of at least 1 week were included in this study. Results: The search strategy resulted in the retrieval of 185 publications. After the application of the eligibility criteria, 21 articles were selected for a qualitative analysis. Conclusions: The cryopreservation process must be carried out in 6 stages: tooth disinfection, pulp extraction, cell isolation, cell proliferation, cryopreservation, and thawing. In addition, it can be inferred that the use of dimethyl sulfoxide, programmable freezing, and storage in liquid nitrogen are associated with a high rate of cell viability after thawing and a high rate of cell proliferation in both primary and permanent teeth.

Effect of Hanwoo Diets Containing Linseed on Plasma Cholesterol Levels of Humans to Beef Consumption and Change in n-6/n-3 Fatty Acid of Loin Fat (아마씨앗 첨가 한우사료가 등심 지방의 n-6/n-3 변화 및 이를 섭취한 사람의 혈중 콜레스테롤 함량에 미치는 영향)

  • Park, Sang-Oh;Park, Byung-Sung;Yuh, In-Suh;Hwangbo, Jong;Bang, Han-Tae
    • Journal of the Korean Applied Science and Technology
    • /
    • v.31 no.2
    • /
    • pp.265-276
    • /
    • 2014
  • The purpose of this study was to evaluate the effect on lowering blood LDL-C in an adult human, by taking n-6/n-3 balanced Hanwoo beef and reducing n-6/n-3 in loin of Hanwoo beef. The randomized complete block design was used to conduct an experiment with a total of 20 castrated Hanwoo cattles, which were divided into two groups. Each group had 10 cattles, and the control group consisted of absence of linseed, while n-3 treatment group (n-3 group) had linseed. The results showed that n-6/n-3 in loin and blood was decreased to under 4:1 in n-3 group, while oleic acid as an monounsaturated fatty acid was increased by 52.79% compared to the control group. In above 70% of the clinical subjects who ate the balanced Hanwoo beef, the blood triglyceride, total cholesterol, and LDL-C were decreased by 25.35, 5.22, and 17.59%. However, in the subjects who ate the imported beef, and not the common Hanwoo beef, the same parameters were increased by 9.05, 8.21, and 21.70%, respectively. When the balanced Hanwoo beef were eaten, HDL-C were increased by 6.07% but the imported beef and common Hanwoo beef had those values decreased by 14.46 and 11.46%, respectively. The blood glucose was decreased by 6.42 and 11.82% in the subjects who ate balanced Hanwoo beef and common Hanwoo beef, respectively but the subjects who ate the imported beef had an increase by 15.19%.

Study on the Safety of Firefly Luciferase in Human as a Transient Reporter Gene of Oncolytic Virotherapy (항암 바이러스 치료제의 보고유전자로써 반딧불이 루시퍼레이즈의 인체 내 안전성에 대한 연구)

  • Hong, Young Mi;Yoon, Woong Hee;Lee, You Ra;Kim, Soo Ji;Ngabire, Daniel;Narayanasamy, Badrinath;Ornella, Mefotse Saha Cyrelle;Kim, Myunghee;Cho, Euna;Lee, Bora;Hwang, Tae-Ho
    • Journal of Life Science
    • /
    • v.31 no.11
    • /
    • pp.1028-1036
    • /
    • 2021
  • Firefly luciferase (FLuc) can function as an efficient marker in the gene and viral therapies. Nonetheless, its clinical translation has been unaccomplished with the concerns on its exogenous nature and the similarity with human fatty acyl-CoA synthetase. In this study, we aimed to show safety of FLuc by conducting a set of preclinical experiments and a human use. Initially, FLuc permeability across the plasma membrane was investigated by delivering the FLuc-carrying viral vector, OTS-412, or the FLuc recombinant protein. After in vitro infection of OTS-412 into different cancer cell lines, FLuc activity was detected only in the cell lysates, but not in culture media. In addition, recombinant FLuc protein further showed the impermeability against the plasma membrane. Similar result was also observed in the in vivo experiment. After being injected into the VX2 tumor-bearing rabbit, the FLuc exclusively resided within the tumor tissue without being detected in the blood plasma or other organs. Human cancer cell lines originated from various organs were lysed and treated to the FLuc, and none of the human substrates was reactive against the FLuc. As a final step, FLuc recombinant protein was intravenously injected into a human. The luciferase was degraded with the half-life of 20 to 30 minutes in blood, and was untraceable from 1.5 hr after the injection. In addition, the blood plasma was nonresponsive against the fatty acids. Hematological analysis was also comparable between the pre- and post-injection. Altogether, our study collectively demonstrates the safety of the firefly luciferase.

Recent Studies on the Edible Plant Vaccine for Prophylactic Medicine against Microorganism-Mediated Diseases (세균성 질병 예방을 위한 식물 경구 백신 연구 동향)

  • Hahn Bum-Soo;Jeong Young-Jae;Roh Kyung-Hee;Park Jong-Sug;Cho Kang-Jin;Kim Yong-Hwan;Kim Jong-Bum
    • Journal of Plant Biotechnology
    • /
    • v.32 no.4
    • /
    • pp.233-241
    • /
    • 2005
  • Plants have considerable advantages for the production of antigenic proteins because they provide an inexpensive source of protein and an easy administration of vaccine. Since a publication describing edible plant vaccine of HBsAg in 1992, a number of laboratories around the world have studied the use of plants as the bioreactor to produce antigenic proteins of human or animal pathogens. Over the last ten years, these works have been mainly focused on three major strategies for the production of antigenic proteins in plants: stable genetic transformation of either the nuclear or plastid genome, or transient expression in plants using viral vectors. As many antigenic proteins have been expressed in tobacco, also several laboratories have succeeded to express genes encoding antigenic proteins in other crop plants: potato, tomato, maize, carrot, soybean and spinach. At present many works for the production of edible plant vaccine against bacteria-mediated diseases have mostly performed the studies of enterotoxins and adhesion proteins. Also the development of new-type antigens (pili, flagella, surface protein, other enterotoxin and exotoxin etc.) is required for various targets and more efficacy to immunize against microorganism pathogens. Many works mostly studied in experimental animals had good results, and phase I clinical trial of LTB clearly indicated its immunogenic ability. On the other hand, edible plant vaccines have still problems remained to be solved. In addition to the accumulation of sufficient antigen in plants, human health, environment and agriculture regulation should be proven. Also oral tolerance, the physiological response to food antigens and commensal flora is the induction of a state of specific immunological unresponsiveness, needs to be addressed before plant-derived vaccine becomes a therapeutic option.

Sanguinarine Increases Sensitivity of Human Gastric Adenocarcinoma Cells to TRAIL-mediated Apoptosis by Inducing DR5 Expression and ROS Generation (AGS 인체 위암세포에서 DR5의 발현 및 ROS 생성의 증가를 통한 sanguinarine과 TRAIL 혼합처리의 apoptosis 유도 활성 촉진)

  • Lee, Taek Ju;Im, Yong Gyun;Choi, Woo Young;Choi, Sung Hyun;Hwang, Won Deok;Choi, Yung Hyun
    • Journal of Life Science
    • /
    • v.24 no.9
    • /
    • pp.927-934
    • /
    • 2014
  • Sanguinarine, a benzophenanthridine alkaloid originally derived from the root of Sanguinaria canadensis, has been shown to possess antimicrobial, antioxidant, and anti-cancer properties. Although tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) is known to induce apoptosis in cancer cells, but not most normal cells and has shown efficacy in a phase 2 clinical trial, development of resistance to TRAIL by tumor cells is a major roadblock. Our previous study indicated that treatment with TRAIL in combination with subtoxic concentrations of sanguinarine sensitized TRAIL-mediated apoptosis in TRAIL-resistant human gastric carcinoma AGS cells; however, the detailed mechanisms are not fully understood. In this study, we show that sanguinarine sensitizes AGS cells to TRAIL-mediated apoptosis as detected by MTT assay, agarose gel electrophoresis, chromatin condensation and flow cytometry analysis. Combined treatment with sanguinarine and TRAIL effectively induced expression of death receptor (DR) 5 but did not affect expression of DR4 and mitogen activated protein kinases signaling molecules. Moreover, the combined treatment with sanguinarine and TRAIL increased the generation of reactive oxygen species (ROS); however, N-acetylcysteine, ROS scavenger, significantly recovered growth inhibition induced by the combined treatment. Taken together, our results indicate that sanguinarine can potentiate TRAIL-mediated apoptosis through upregulation of DR5 expression and ROS generation.

A Case Study on Performance Analysis of Antimicrobial Copper Film Attaching to Window for Responding to COVID-19 and Others (코로나19 등 대응을 위한 "유리창 부착용 항바이러스 동필름" 성능분석 사례연구)

  • Kim, Seong Je
    • Journal of Korean Society of Disaster and Security
    • /
    • v.14 no.1
    • /
    • pp.23-40
    • /
    • 2021
  • In the era of the global coronal 19 pandemic, there is a risk of cross-infection in hospitals at the stage where treatments and vaccines are currently being developed and marketed, so individuals should enhance their acquired immunity and generalize their living systems by the performance of copper ions in the social environment. In order to prevent the spread of infection, the need for anti-bacterial film and its efficacy were analyzed through anti-viral performance tests based on research and development cases of worldwide and immemorial time. he Korea Construction Research Institute (KCL) has received anti-bacterial performance certification and anti-viral test scores from the "National Approval Performance Certification Agency." At the time, NCCP 43326 Human Corona virus (BetaCoV/Korea/KCDC03/2020), which was approved by the Centers for Disease Control and Prevention, was introduced to ensure that the activity rate of infected cells was satisfied in the anti-viral performance test. Anti-proliferation measures for the Corona 19 virus require a quality clinical trial study comparing the experimental group within the glass space where the antiviral copper film is constructed with the comparator of the same condition without copper film.