As an important means and research core of regenerative medicine,stem cells have shown great application value in the treatment of major clinical refractory diseases. Among them,induced pluripotent stem cells (iPSC) are more and more widely used because of their advantages such as less restriction of donor cells,stable quality and less ethical restrictions. In particular,the gradual maturation of pluripotent stem cell directed differentiation technology and gene editing technology has greatly accelerated the development of iPSC-derived cell therapy. The efficacy and safety of cell therapy products derived from induced pluripotent stem cells have been confirmed in non-clinical studies. However,iPSC are derived from the reprogramming of terminal somatic cells from human sources,and the production process and quality control of its derived cell products are extremely complicated. Therefore,there may still be large safety risks in the clinical application of such cell products,such as,tumorigenicity,ectopic distribution,immune rejection and other potential risks. This paper will introduce the basic concepts and characteristics of iPSC and their derived cell products,and focus on the possible problems and evaluation strategies in non-clinical research stage,taking stem cell products for treatment of Parkinson's disease as an example.
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