The burgeoning field of bioengineering has witnessed significant strides due to the advent of stem cell models, particularly in their application in advanced therapy medicinal products (ATMPs). In this review, we examine the multifaceted impact of these developments, emphasizing the potential of stem cell models to enhance the sophistication of ATMPs and to offer alternatives to animal testing. Stem cell-derived tissues are particularly promising because they can reshape the preclinical landscape by providing more physiologically relevant and ethically sound platforms for drug screening and disease modelling. We also discuss the critical challenges of reproducibility and accuracy in measurements to ensure the integrity and utility of stem cell models in research and application. Moreover, this review highlights the imperative of stem cell models to align with regulatory standards, ensuring using stem cells in ATMPs translates into safe and effective clinical therapies. With regulatory approval serving as a gateway to clinical adoption, the collaborative efforts between scientists and regulators are vital for the progression of stem cell applications from bench to bedside. We advocate for a balanced approach that nurtures innovation within the framework of rigorous validation and regulatory compliance, ensuring that stem cell-base solutions are maximized to promote public trust and patient health in ATMPs.

Between the completion of the mesenchymal stem cell (MSCs) preparation and the transplantation into the patient, there is a time interval during which the quality control and transport of MSC products occur, which usually involves suspending the cells in normal saline in an oxygen-glucose deprivation (OGD) microenvironments. Thus, how to effectively maintain MSC viability during the abovementioned time interval is bound to play a significant role in the therapeutic effect of MSC-based therapies. Recently, menstrual blood-derived endometrial stem cells (MenSCs) have attracted extensive attention in regenerative medicine due to their superior biological characteristics, including noninvasive protocols for their collection, abundant source material, stable donation, and autotransplantation. Therefore, this study aimed to mainly determine the effect of storage temperature on the maintenance of MenSC viabilities in an OGD microenvironment, and to preliminarily explore its potential mechanism. Simultaneously, the effects of solvents commonly used in the clinic on MenSC viability were also examined to support the clinical application of MenSCs. Consequently, our results demonstrated that in the OGD microenvironment, a nonfreezing low temperature (4°C) was suitable and cost-effective for MenSC storage, and the maintenance of MenSC viability stored at 4°C was partly contributed by the sustained releases of autophagy-produced energy. Furthermore, the addition of human serum albumin effectively inhibited the cell sedimentations in the MenSC suspension. These results provide support and practical experience for the extensive application of MenSCs in the clinic.