Cell Journal، جلد ۲۶، شماره ۱۱، صفحات ۶۵۶-۶۶۸

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عنوان انگلیسی Developing A General Checklist for The Effective Administration of Extracellular Vesicles in Biomedical and Clinical Research
چکیده انگلیسی مقاله The potential application of extracellular vesicles (EVs) in regenerative and personalized medicine has attracted substantial interest in recent years, highlighting the need for standardized protocols for their administration in preclinical and clinical settings. EVs, which play critical roles in intercellular communication and have significant therapeutic potential, have prompted extensive research and advancements in their clinical applications. However, the rapid evolution of this field has also revealed variability in how EVs are isolated, characterized, and used across different studies. Over the past decade, organizations such as the International Society for Extracellular Vesicles (ISEV) and the International Society for Cell and Gene Therapy (ISCT) have actively worked to address these challenges by proposing frameworks for standardizing EV-related research. As the clinical evaluation of therapeutic EVs becomes increasingly commonplace, there is a need for practical guidelines and assessment tools that can aid in evaluating their efficacy and safety. In this context, we propose a comprehensive checklist designed to guide researchers and clinicians in considering critical aspects when designing and conducting biomedical and clinical studies involving EVs. This checklist aims to enhance the standardization of trials and therapeutic procedures, ensuring that clinical reports are prepared with adequate detail. By controlling reproducibility and transparency in research, we believe that our proposed guidelines will contribute significantly to advancing the application of EVs in clinical practice.
کلیدواژه‌های انگلیسی مقاله Biological Products,Extracellular vesicles,Good Manufacturing Practices,Mesenchymal Stem/Stromal Cells,Translational Medical Research

نویسندگان مقاله Azadeh Haghighitalab |
Stem Cells and Regenerative Medicine Research Group, Academic Center for Education, Culture and Research (ACECR), Khorasan Razavi, Mashhad, Iran

Mahboubeh Kazemi Noughabi |
Stem Cells and Regenerative Medicine Research Group, Academic Center for Education, Culture and Research (ACECR), Khorasan Razavi, Mashhad, Iran

Halimeh Hassanzadeh |
Stem Cells and Regenerative Medicine Research Group, Academic Center for Education, Culture and Research (ACECR), Khorasan Razavi, Mashhad, Iran

Faezeh Shekari |
Department of Stem Cells and Developmental Biology, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran

Maryam Moghadam Matin |
Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran

Rebecca Lim |
The Ritchie Centre, Hudson Institute of Medical Research, Clayton, Victoria, Australia

Hamid Reza Bidkhori |
The Ritchie Centre, Hudson Institute of Medical Research, Clayton, Victoria, Australia

Ahmad Reza Bahrami |
Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran


نشانی اینترنتی https://www.celljournal.org/article_721756_f9e586f9c4a35a736a8cb23d948c2857.pdf
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