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Recent advancements in organoid technology have led to a vigorous movement towards utilizing it as a substitute for animal experiments. Organoid technology offers versatile applications, particularly in toxicity testing of pharmaceuticals or chemical substances. However, for the practical use in toxicity testing, minimal guidance is required to ensure reliability and relevance. This paper aims to provide minimal guidelines for practical uses of kidney organoids derived from human pluripotent stem cells as a toxicity evaluation model in vitro.
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Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function.This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.
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This report presents guidelines for the systematic management of packaging, storage, transportation, and traceability of source cells used for organoid research. Given the important role of source cells in organoid studies, it is important to ensure the preservation of their quality and integrity throughout transportation and distribution processes. The proposed guidelines, therefore, call for a cohesive strategy through these stages to minimize the risks of contamination, deterioration, and loss–threats that significantly compromise the safety, efficacy, and efficiency of source cells. Central to these guidelines is the quality control measures that include roles and responsibilities across the entire supply chain, with recommendations specific to packaging materials, transportation facilities, and storage management. Furthermore, the need for an integrated management system is emphasized, spanning from source cell collection to the final application. This system is crucial for maintaining the traceability and accountability of source cells, facilitating the sharing, distribution, and utilization on a global scale, and supporting to advance organoid research and development.
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An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.
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To address the limitations of animal testing, scientific research is increasingly focused on developing alternative testing methods. These alternative tests utilize cells or tissues derived from animals or humans for in vitro testing, as well as artificial tissues and organoids. In western countries, animal testing for cosmetics has been banned, leading to the adoption of artificial skin for toxicity evaluation, such as skin corrosion and irritation assessments. Standard guidelines for skin organoid technology becomes necessary to ensure consistent data and evaluation in replacing animal testing with in vitro methods. These guidelines encompass aspects such as cell sourcing, culture techniques, quality requirements and assessment, storage and preservation, and organoid-based assays.
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Recent amendments to regulatory frameworks have placed a greater emphasis on the utilization of in vitro testing platforms for preclinical drug evaluations and toxicity assessments. This requires advanced tissue models capable of accurately replicating liver functions for drug efficacy and toxicity predictions. Liver organoids, derived from human cell sources, offer promise as a reliable platform for drug evaluation. However, there is a lack of standardized quality evaluation methods, which hinders their regulatory acceptance. This paper proposes comprehensive quality standards tailored for liver organoids, addressing cell source validation, organoid generation, and functional assessment. These guidelines aim to enhance reproducibility and accuracy in toxicity testing, thereby accelerating the adoption of organoids as a reliable alternative or complementary tool to animal testing in drug development. The quality standards include criteria for size, cellular composition, gene expression, and functional assays, thus ensuring a robust hepatotoxicity testing platform.
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The objective of standard guideline for utilization of human lung organoids is to provide the basic guidelines required for the manufacture, culture, and quality control of the lung organoids for use in non-clinical efficacy and inhalation toxicity assessments of the respiratory system. As a first step towards the utilization of human lung organoids, the current guideline provides basic, minimal standards that can promote development of alternative testing methods, and can be referenced not only for research, clinical, or commercial uses, but also by experts and researchers at regulatory institutions when assessing safety and efficacy.
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This study offers a comprehensive overview of brain organoids for researchers. It combines expert opinions with technical summaries on organoid definitions, characteristics, culture methods, and quality control. This approach aims to enhance the utilization of brain organoids in research. Brain organoids, as three-dimensional human cell models mimicking the nervous system, hold immense promise for studying the human brain. They offer advantages over traditional methods, replicating anatomical structures, physiological features, and complex neuronal networks. Additionally, brain organoids can model nervous system development and interactions between cell types and the microenvironment. By providing a foundation for utilizing the most human-relevant tissue models, this work empowers researchers to overcome limitations of two-dimensional cultures and conduct advanced disease modeling research.
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Background@#Breaking the chain of disease transmission from overseas is necessary to control new infectious diseases such as coronavirus disease 2019 effectively. In this study, we developed a mobile app called Self-Symptom Checker (SSC) to monitor the health of inbound travelers. @*Methods@#SSC was developed for general users and administrators. The functions of SSC include non-repudiation using QR (quick response) codes, monitoring fever and respiratory symptoms, and requiring persons showing symptoms to undergo polymerase chain reaction tests at nearby screening stations following a review of reported symptoms by the Korea Disease Control and Prevention Agency, as well as making phone calls, via artificial intelligence or public health personnel, to individuals who have not entered symptoms to provide the necessary information. @*Results@#From February 12 to March 27, 2020, 165,000 people who were subjected to the special entry procedure installed SSC. The expected number of public health officers and related resources needed per day would be 800 if only the phone was used to perform symptom monitoring during the above period. @*Conclusion@#By applying SSC, more effective symptom monitoring was possible. The daily average number of health officers decreased to 100, or 13% of the initial estimate. SSC reduces the work burden on public healthcare personnel. SSC is an electronic solution conceived in response to health questionnaires completed by inbound travelers specified in the World Health Organization International Health Regulations as a requirement in the event of a pandemic.
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The management of emerging infectious diseases cannot help but completely depend on non-pharmaceutical interventions in the early stages of the outbreak. Consequently, South Korea has developed and implemented the 3T (test-trace-treat) models, non-pharmaceutical infection prevention and control (IPC) measures, in response to the coronavirus disease 2019 (COVID-19) pandemic. The IPC measures have gained global attention, rendering them to be essential in the development of a shareable, reusable, and applicable protocol for future pandemics. This study was conducted to identify the requirements necessary for standardizing the IPC measures. Three new work items of the 18 3T models were proposed to ISO/TC 304 (International Organization for Standardization/Technical Committee 304; healthcare organization management). Requirements for each IPC measure, identified by participating members (P-members) countries during the ISO ballots, were analyzed in this study. The three new work items were approved by the P-members countries after a 3-month ballot. There was a consensus that the three IPC measure models should be International Standards (IS). Other comments include (1) the models should include not only COVID-19 but also any respiratory pandemic; and (2) keep donning of level D protection at screening sites as an optional protocol, in consideration for the lack of personal protective equipment. Standardization is a systematic process of developing internationally agreed-upon wisdom and knowledge that consider and respect the diversity and universality of each country. It is expected that such standardized applicable IPC measure models contribute to global efforts to rapidly respond to a public health emergency of international concern during its early stages.
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OBJECTIVES: To develop dedicated markup language for clinical contents models (CCM) to facilitate the active use of CCM in electronic health record systems. METHODS: Based on analysis of the structure and characteristics of CCM in the clinical domain, we designed extensible markup language (XML) based CCM markup language (CCML) schema manually. RESULTS: CCML faithfully reflects CCM in both the syntactic and semantic aspects. As this language is based on XML, it can be expressed and processed in computer systems and can be used in a technology-neutral way. CONCLUSIONS: CCML has the following strengths: it is machine-readable and highly human-readable, it does not require a dedicated parser, and it can be applied for existing electronic health record systems.
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Sistemas de Computación , Registros Electrónicos de Salud , Electrónica , Electrones , SemánticaRESUMEN
OBJECTIVE: The development of a dictionary of clinical terminology based on medical concepts is essential for understanding the precise meanings of the clinical terminologies used in EMR systems. For an unambiguous presentation and retrieval of the terminologies in practical data entry, this study propose a clinical terminology dictionary, which integrates and manages the wide range of data in EMR Systems. METHODS: The structure of the system and attributes were defined. The structures should satisfy the following: all terminologies should be consistent with the medical concepts, all concepts have multiple relationships, all concepts have many synonyms, all concepts can be mapped to concepts in an external medical terminology system, and all concepts can be grouped as value sets by setting the "domain". RESULTS: With the derived entity objects and attributes, the physical clinical terminology database was constructed and an editor was developed using MySQL 5.0.45 and JAVA Swing. To verify the structure and contents of the developed clinical terminology dictionary, the terminology experts used the editor to search and register the medical concepts. CONCLUSION: Although the contents refinement and complements are an unsolved problem, it is anticipated that the proposed research will provide unambiguous meanings of the clinical terminology and be applicable to many services in EMR systems.