The Center for Drug Evaluation (CDE) has released a set of “Guidelines for Clinical Trial Techniques for Human-Derived Stem Cells and Derived Cell Therapy Products,” which are now in immediate effect. These guidelines focus on clinical trials for stem cell-related products that are potential candidates for product approval, distinguishing them from investigator-initiated studies or other forms of research.<\/p>\n\n\n\n
Scope and Definition of Human-Derived Stem Cells<\/strong> Clinical Trial Techniques and Processes<\/strong>
The document defines “human-derived stem cells” as encompassing human embryonic stem cells, adult stem cells, and induced pluripotent stem cells. “Human-derived stem cell derived cell therapy products” refer to cell therapy products that originate from human-derived stem cells or mature somatic cell cells.<\/p>\n\n\n\n
The clinical trial techniques outlined in the guidelines include a range of in vitro operations such as collection and transportation of cells from donors, extraction, separation, purification, cultivation, amplification, in vitro stimulation, gene editing or modification, induction of differentiation, cryopreservation and resuscitation, and transportation of stem cell-related products.<\/p>\n\n\n\n