Developing A General Checklist for The Effective Administration of Extracellular Vesicles in Biomedical and Clinical Research
نویسندگان
1 Stem Cells and Regenerative Medicine Research Group, Academic Center for Education, Culture and Research (ACECR), Khorasan Razavi, Mashhad, Iran
2 Stem Cells and Regenerative Medicine Research Group, Academic Center for Education, Culture and Research (ACECR), Khorasan Razavi, Mashhad, Iran
3 Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran
4 Advanced Therapy Medicinal Product Technology Development Center (ATMP-TDC), Cell Sciences Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
5 Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran
6 Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran
7 Stem Cells and Regenerative Medicine Research Group, Academic Center for Education, Culture and Research (ACECR), Khorasan Razavi, Mashhad, Iran
8 Department of Stem Cells and Developmental Biology, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
doi
10.22074/cellj.2025.2039721.1659چکیده
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.
