• Title/Summary/Keyword: Human trials

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A Survey on the Current Status of Human Research Protection Program Settlement and Subject Protection Activities in Korea (국내 임상시험 및 대상자 보호프로그램 도입 현황과 안전관 리체계에 대한 설문조사 연구)

  • Park, Sinyoung;Cho, Su Jin;Seo, Kyung Jeong;Kim, Jin Seok
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.28-36
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    • 2021
  • Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

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Differential Behaviour of Selenium Analogs against Anticancer Drug Induced Apoptosis of Lymphocytes in Human Peripheral Blood

  • Elango, Sonaa;Subbiah, Usha;Jain, Jeong
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.5
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    • pp.2527-2533
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    • 2016
  • Sensitising cancer cells and at the same time desensitizing normal cells is a double task in cancer management. Agents which can combat the debilitating side effects of cancer therapeutics and simultaneously synergize with anticancer agents in specifically targeting cancer cells are needed. Selenium, a proven anticarcinogen, gains due importance in terms of its efficacy to combat the side effects of cancer therapy. This study is a comparative analysis of the chemoprotective effects of selenium compounds, methyl selenol (generated from organic selenomethionine (5mmol/L ; METase 40U/L)) and sodium selenite (inorganic form)($30{\mu}M$) in peripheral blood human lymphocytes exposed to cisplatin and mitomycin. Biochemical alterations occurring in many cells during apoptosis include loss of plasma membrane phospholipid asymmetry, DNA fragmentation, and activation of caspase-3. The present study demonstrated that the selenium metabolite and selenite are efficient in protecting lymphocytes undergoing DNA damage and exerted their activity by reducing caspase 3 expression. Interestingly organic methylselenol (MeSe) was found to offer more protective effects compared to inorganic selenite (SeL), by reducing the induction of apoptosis by the cytotoxic agents. This suggests that MeSe and to a lesser extent selenite might have potential for assessment in clinical trials and could be considered as strong candidates in pharmacogenomics or in the nutriprotective arena.

Isolation and Characterization of Cells from Human Adipose Tissue Developing into Osteoblast and Adipocyte (인간 지방조직에서 분리된 줄기세포의 표면항원 및 다분화능 확인)

  • Cho, Hye-Kyung
    • Korean Journal of Clinical Laboratory Science
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    • v.40 no.2
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    • pp.106-112
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    • 2008
  • Bone marrow derived mesenchymal stem cells (BMSCs) are largely studied for their potential clinical use. But it is hard to get enough number of those cells for clinical trials and give serious pain to the patients. Adipose tissue is derived from the embryonic mesenchyme and contains a stroma that is easily isolated with large amount. This cell population (adipose derived stem cells: ADSCs) can be isolated from human lipoaspirates and like MSCs, differentiate toward the osteogenic, adipogenic, myogenic and chondrogenic lineages. To confirm whether adipose tissue contains stem cells, the ADSCs extracted from omental or subcutaneous fat tissue were expanded during third to fifth passages. The phenotype of the ADSCs was identified by the conventional cell surface markers using flow cytometry: positive for CD29 and CD44, but negative for CD34, CD45, CD117 and HLA-DR that similar to those observed on BMSCs. The ADSCs were able to differentiate into the osteoblast or adipocytes with induction media. Finally, ADACs expressed multiple CD marker antigens similar to those observed on BMSCs and differentiated into osteoblast, adipocyte. With this, human adipotissue contains multipotent cells and may represent an alternative stem cell source to bone marrow-derived MSCs.

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Exploring the Potential of Modifying Visual Stimuli in Virtual Reality to Reduce Hand Tremor in Micromanipulation Tasks

  • Prada, John;Park, Taiwoo;Jang, Sunjin;Im, Jintaek;Song, Cheol
    • Current Optics and Photonics
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    • v.1 no.6
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    • pp.642-648
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    • 2017
  • Involuntary hand tremor has been a serious challenge in micromanipulation tasks and thus draws a significant amount of attention from related fields. To minimize the effect of the hand tremor, a variety of mechanically assistive solutions have been proposed. However, approaches increasing human awareness of their own hand tremor have not been extensively studied. In this paper, a head mount display based virtual reality (VR) system to increase human self-awareness of hand tremor is proposed. It shows a user a virtual image of a handheld device with emphasized hand tremor information. Provided with this emphasized tremor information, we hypothesize that subjects will control their hand tremor more effectively. Two methods of emphasizing hand tremor information are demonstrated: (1) direct amplification of tremor and (2) magnification of virtual object, in comparison to the controlled condition without emphasized tremor information. A human-subject study with twelve trials was conducted, with four healthy participants who performed a task of holding a handheld gripper device in a specific direction. The results showed that the proposed methods achieved a reduced level of hand tremor compared with the control condition.

The Development of Serious Game for the Cognitive Ability Training using Smart Device (스마트디바이스를 활용한 인지 능력 훈련 기능성 게임 개발)

  • Yang, Yeong-Wook;Lim, Heui-Seok
    • Journal of Korea Game Society
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    • v.11 no.6
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    • pp.23-31
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    • 2011
  • The cognitive abilities are functions in human brain. They are closely with the real life. The cognitive abilities are likely to be decreased when human gets older and older. Fortunately, due to the plasticity of human brain, it is possible to help recover and rehabilitate brain function. Those efforts are called brain training and cognitive ability training. The cognitive ability training needs continuous trials and efforts. But many users feel boring because of simple repetitive works. This paper proposes a cognitive training system implemented in a smart device. The proposed system is designed to make users to focus on the repetitive training by using game-based tasks on the smart device. It shows that the proposed system is effective to attention and flexible on cognitive training game.

Ginseng and Diabetes: The Evidences from In Vitro, Animal and Human Studies

  • Yuan, Hai-Dan;Kim, Jung-Tae;Kim, Sung-Hoon;Chung, Sung-Hyun
    • Journal of Ginseng Research
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    • v.36 no.1
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    • pp.27-39
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    • 2012
  • Panax ginseng exhibits pleiotropic beneficial effects on cardiovascular system, central nervous system, and immune system. In the last decade, numerous preclinical findings suggest ginseng as a promising therapeutic agent for diabetes prevention and treatment. The mechanism of ginseng and its active components is complex and is demonstrated to either modulate insulin production/secretion, glucose metabolism and uptake, or inflammatory pathway in both insulin-dependent and insulin-independent manners. However, human studies are remained obscure because of contradictory results. While more studies are warranted to further understand these contradictions, ginseng holds promise as a therapeutic agent for diabetes prevention and treatment. This review summarizes the evidences for the therapeutic potential of ginseng and ginsenosides from in vitro studies, animal studies and human clinical trials with a focus on diverse molecular targets including an AMP-activated protein kinase signaling pathway.

Effects of Adenoviral Gene Transduction on the Stemness of Human Bone Marrow Mesenchymal Stem Cells

  • Marasini, Subash;Chang, Da-Young;Jung, Jin-Hwa;Lee, Su-Jung;Cha, Hye Lim;Suh-Kim, Haeyoung;Kim, Sung-Soo
    • Molecules and Cells
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    • v.40 no.8
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    • pp.598-605
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    • 2017
  • Human mesenchymal stem cells (MSCs) are currently being evaluated as a cell-based therapy for tissue injury and degenerative diseases. Recently, several methods have been suggested to further enhance the therapeutic functions of MSCs, including genetic modifications with tissue- and/or diseasespecific genes. The objective of this study was to examine the efficiency and stability of transduction using an adenoviral vector in human MSCs. Additionally, we aimed to assess the effects of transduction on the proliferation and multipotency of MSCs. The results indicate that MSCs can be transduced by adenoviruses in vitro, but high viral titers are necessary to achieve high efficiency. In addition, transduction at a higher multiplicity of infection (MOI) was associated with attenuated proliferation and senescence-like morphology. Furthermore, transduced MSCs showed a diminished capacity for adipogenic differentiation while retaining their potential to differentiate into osteocytes and chondrocytes. This work could contribute significantly to clinical trials of MSCs modified with therapeutic genes.

The New in vitro Oral Irritation Test Method for Toothpaste using YD-38 Oral Mucosal Cell Line (치약에 대한 YD-38 세포주를 활용한 새로운 구강 점막 자극 시험방법)

  • Nam, Gi Baeg;Cho, Sun-A;Cho, Jun-Cheol;Kim, Chanho;Kim, Yoo-Jin;Lee, John Hwan;Shin, Kyeho
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.38 no.4
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    • pp.305-310
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    • 2012
  • Through our entire life, oral care products such as toothpaste are used. Thus the safety of oral care products used every day to our mouth is very important. As the previous study in animal tests or clinical trials, surfactant in toothpaste may cause the oral irritation. However, EU cosmetics legislation prohibits animal testing of cosmetics and its ingredient for animal welfare. Therefore the development of alternative in vitro test has been actively performed to replace or reduce using the animal in many areas. However, the way to evaluate oral mucosal toxicity has been done using animal models or clinical trials from now on. Even more, the experiment with human oral 3D tissue or human oral cell line is used recently. The aim of this study is the development of oral mucosal irritation method without using animal for the safety of the oral care product. We developed in vitro test method for oral irritation by using human oral cell line (YD-38 cell) acceptable to toothpaste which contains insoluble material. By the results of this assay, we could discriminate toothpaste with or without irritating substance as same manner in animal studies reported previously. In addition, we confirmed that toothpaste for babies and children toothpaste irritated oral musoca lower than the general adult toothpaste. The present study suggest that this new in vitro method by using human oral cell line (YD-38 cell) could be used for evaluation of oral irritation without using animal.

Mid-infrared (MIR) spectroscopy for the detection of cow's milk in buffalo milk

  • Anna Antonella, Spina;Carlotta, Ceniti;Cristian, Piras;Bruno, Tilocca;Domenico, Britti;Valeria Maria, Morittu
    • Journal of Animal Science and Technology
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    • v.64 no.3
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    • pp.531-538
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    • 2022
  • In Italy, buffalo mozzarella is a largely sold and consumed dairy product. The fraudulent adulteration of buffalo milk with cheaper and more available milk of other species is very frequent. In the present study, Fourier transform infrared spectroscopy (FTIR), in combination with multivariate analysis by partial least square (PLS) regression, was applied to quantitatively detect the adulteration of buffalo milk with cow milk by using a fully automatic equipment dedicated to the routine analysis of the milk composition. To enhance the heterogeneity, cow and buffalo bulk milk was collected for a period of over three years from different dairy farms. A total of 119 samples were used for the analysis to generate 17 different concentrations of buffalo-cow milk mixtures. This procedure was used to enhance variability and to properly randomize the trials. The obtained calibration model showed an R2 ≥ 0.99 (R2 cal. = 0.99861; root mean square error of cross-validation [RMSEC] = 2.04; R2 val. = 0.99803; root mean square error of prediction [RMSEP] = 2.84; root mean square error of cross-validation [RMSECV] = 2.44) suggesting that this method could be successfully applied in the routine analysis of buffalo milk composition, providing rapid screening for possible adulteration with cow's milk at no additional cost.

A Current Research Insight into Function and Development of Adjuvants (면역보조제의 작용 및 개발)

  • Sohn, Eun-Soo;Son, EunWha;Pyo, SuhkNeung
    • IMMUNE NETWORK
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    • v.4 no.3
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    • pp.131-142
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    • 2004
  • In recent years, adjuvants have received much attention because of the development of purified subunit and synthetic vaccines which are poor immunogens and require adjuvants to evoke the immune response. Therefore, immunologic adjuvants have been developed and testing for most of this century. During the last years much progress has been made on development, isolation and chemical synthesis of alternative adjuvants such as derivatives of muramyl dipeptide, monophosphoryl lipid A, liposomes, QS-21, MF-59 and immunostimulating complexes (ISCOMS). Biodegradable polymer microspheres are being evaluated for targeting antigens on mucosal surfaces and for controlled release of vaccines with an aim to reduce the number of doses required for primary immunization. The most common adjuvants for human use today are aluminum hydroxide and aluminum phosphate. Calcium phosphate and oil emulsions have been also used in human vaccination. The biggest issue with the use of adjuvants for human vaccines is the toxicity and adverse side effects of most of the adjuvant formulations. Other problems with the development of adjuvants include restricted adjuvanticity of certain formulations to a few antigens, use of aluminum adjuvants as reference adjuvant preparations under suboptimal conditions, non-availability of reliable animal models, use of non-standard assays and biological differences between animal models and humans leading to the failure of promising formulations to show adjuvanticity in clinical trials. The availability of hundreds of different adjuvants has prompted a need for identifying rational standards for selection of adjuvant formulations based on safety and sound immunological principles for human vaccines. The aim of the present review is to put the recent findings into a broader perspective to facilitate the application of these adjuvants in general and experimental vaccinology.