Stem cell therapy: Cultivation process impacts efficacy and safety

Medical experts caution that increasing the quantity of stem cells through cultivation does not necessarily guarantee higher therapeutic efficacy or safety. While stem cells can be expanded in vitro to reach counts of tens of millions or even 100 million, the quality and characteristics of the cells are heavily influenced by the cultivation process.

Research from Sapienza University of Rome suggests that repeated subculturing can lead to changes in cell properties, potentially reducing their ability to regulate immune responses. Furthermore, studies involving animal models, such as those conducted at Texas A&M University, have indicated that repeated administration of cultured stem cells may trigger inflammatory responses. These reactions can be linked to the cells' origin or the presence of residual proteins from culture media, such as fetal bovine serum.

In South Korea, strict regulations govern the use of cultured stem cells. Patients cannot be treated with directly cultivated and expanded cells unless they have undergone specific approval processes, such as being designated as a cell therapy product by the Ministry of Food and Drug Safety or being part of an approved clinical trial. Consequently, many current domestic treatments utilize uncultured stem cells, such as those derived from bone marrow or stromal vascular fractions (SVF) from adipose tissue.