ISSCR’s Guidelines for Stem Cell Research and Clinical Translation: Supporting development of safe and efficacious stem cell-based interventions

Abstract

The ISSCR’s revised Guidelines for Stem Cell Research and Clinical Translation reflect the organization’s commitment to opposing premature commercialization of stem cell-based interventions and supporting the development of products that meet stringent ethical, scientific, and regulatory standards. The Guidelines contain five important new recommendations concerning clinical translation of stem cell products.

Effect of miR-21 in mesenchymal stem cells-derived extracellular vesicles behavior

“…MSC from human umbilical cord stroma expressed the characteristic markers of stem cells recognized by the ISSCR [11,23,29] in addition to being susceptible to be differentiated into three different mesodermal lines when they are differentially cultured in the laboratory, and these cells showed a high expression of pluripotency genes. Afterward, their EVs showed expression of EV markers and an adequate size according to the latest International Society for Extracellular Vesicles (ISEV) specifications [27,31] (Fig.…”

Capacidades estatais brasileiras na medicina regenerativa: ciência, inovação, regulação, governança e inclusão social

“…Observa-se que, no início da década passada, agências de liderança global em MR tomaram várias iniciativas supranacionais para a harmonização das regulações no setor, por ex. as políticas da Sociedade Internacional de Pesquisa em Células Tronco (ISSCR) (Turner, 2021). Mas, ainda predomina a diversificação regulatória, que é apoiada por organizações como a Sociedade Internacional de Terapia Celular (Ireland et al, 2018).…”

Standardisation is the key to the sustained, rapid and healthy development of stem cell‐based therapy

“…The transition of SCT from small‐scale, customised experiments to routine clinical practice requires standards to assist. Standardisation can not only help SCT develop safely, effectively and ethically, but also prevent its premature commercialisation 28–30 . Therefore, many countries, regions and international organisations around the world have developed corresponding SCT standards, which will strongly promote the further development of the SCT industry.…”

“…Standardisation can not only help SCT develop safely, effectively and ethically, but also prevent its premature commercialisation. 28 , 29 , 30 Therefore, many countries, regions and international organisations around the world have developed corresponding SCT standards, which will strongly promote the further development of the SCT industry. This article aims to summarise the clinical application progress of SCT, and focus on the research progress of SCT standardisation.…”