Yong Kar Wey, Choi Jane Ru, Dolbashid Asdani Saifullah, Wan Safwani Wan Kamarul Zaman
Department of Biomedical Engineering, Faculty of Engineering, University of Malaya, Kuala Lumpur 50603, Malaysia.
Department of Chemical & Petroleum Engineering, Schulich School of Engineering, University of Calgary, Calgary, AB, T2N 1N4, Canada.
Regen Med. 2018 Mar;13(2):219-232. doi: 10.2217/rme-2017-0078. Epub 2018 Mar 6.
An outstanding amount of resources has been used in research on manipulation of human stem cells, especially mesenchymal stem cells (MSCs), for various clinical applications. However, human MSCs have not been fully utilized in clinical applications due to restrictions with regard to their certain biosafety and bioefficacy concerns, for example, genetic abnormality, tumor formation, induction of host immune response and failure of homing and engraftment. This review summarizes the biosafety and bioefficacy assessment of human MSCs in terms of genetic stability, tumorigenicity, immunogenicity, homing and engraftment. The strategies used to reduce the biosafety concerns and improve the bioefficacy of human MSCs are highlighted. In addition, the approaches that can be implemented to improve their biosafety and bioefficacy assessment are briefly discussed.
大量资源已用于人类干细胞，尤其是间充质干细胞（MSC）的研究，以用于各种临床应用。然而，由于某些生物安全性和生物有效性方面的限制，例如遗传异常、肿瘤形成、宿主免疫反应的诱导以及归巢和植入失败，人类MSC在临床应用中尚未得到充分利用。本综述总结了人类MSC在遗传稳定性、致瘤性、免疫原性、归巢和植入方面的生物安全性和生物有效性评估。重点介绍了用于降低人类MSC生物安全性问题并提高其生物有效性的策略。此外，还简要讨论了可用于改善其生物安全性和生物有效性评估的方法。
