International Journal of Molecular Medical Science, 2024, Vol.14, No.2, 123-131 http://medscipublisher.com/index.php/ijmms 128 4.1.2 Validity Chen et al. (2019) argued that the efficacy of MSCs showed significant variability across different clinical trials, which could be caused by a variety of factors, such as cell dose, route of administration, patient disease status, and background. In addition, the mechanism of action of MSCs is complex, and their immunomodulatory function is closely related to the patient's own immune environment, which increases the difficulty of predicting their clinical effects. 4.2 Complexity and unpredictability of immune regulatory mechanisms Castro-Manrreza and Montesinos (2015) mentioned that the immunomodulatory functions of MSCs involve multiple cell types and complex signaling pathways, which makes their immunomodulatory mechanisms extremely complex. Although some of the mechanisms by which MSCs interact with immune cells have been revealed, there are still a lot of unknown areas to explore. This complexity leads to variability and unpredictability in the response of MSCs to individuals in practical applications, which increases the risk and uncertainty of treatment. 4.3 Evaluation of safety and efficacy of cell therapy Peng Xufeng et al. (2020) believe that when MSCs are used to treat autoimmune diseases, their safety and efficacy must be rigorously evaluated. This includes aspects such as the source, quality, quantity, purity of the cells and the long-term effect after treatment. At present, the lack of a unified and standardized evaluation system makes the evaluation of the safety and efficacy of MSCs treatment challenging. 4.4 Technical challenges of cell origin, isolation and culture Sources of MSCs are limited and are usually obtained from tissues such as bone marrow, fat, and cord blood. This limits its wide application in clinical practice. In addition, the isolation and culture of cells is also a technical challenge. Currently, while there are ways to isolate and grow MSCs from these tissues, these methods are often time-consuming, inefficient, and costly. 4.5 Legal, ethical and cost considerations As Ringden et al. (2022) mentioned in their study, MSCs treatment involves multiple aspects such as ethics, law and economy. For example, the legality and compliance of cell sources, the right to information and privacy of patients, and the affordability of treatment costs all need to be considered. These factors may limit the widespread clinical use of MSCs therapy. Therefore, it is necessary to fully consider these aspects when formulating relevant policies and regulations to promote the healthy development of MSCs treatment. 5 Prospect and Research Direction 5.1 Application prospect of MSCs in the treatment of autoimmune diseases Chen et al. (2019) proposed in their study that MSCs have the potential to regulate inflammation, promote tissue repair and maintain immune homeostasis, making them an ideal choice for the treatment of autoimmune diseases. These cells can secrete a variety of anti-inflammatory cytokines and other solute factors, such as transforming growth factor-β (TGF-β), interleukin-10 (IL-10), and so on, effectively inhibit the inflammatory response. At the same time, they can also engage in complex interactions with immune cells, such as T cells and B cells, to regulate the activity of the immune system and prevent excessive immune responses from causing tissue damage. Take systemic lupus erythematosus, a disease caused by the immune system's abnormal attack on its own tissues. Ben-Ami et al. (2011) proposed that MSCs could alleviate the symptoms of systemic lupus erythematosus by inhibiting the activation and proliferation of T cells and reducing the production of pro-inflammatory cytokines. MSCs have shown similar therapeutic effects in autoimmune diseases such as rheumatoid arthritis and Crohn's disease. The positive results of these clinical trials provide a solid basis for the widespread use of MSCs in the treatment of autoimmune diseases. Zaripova et al. (2023) point out that despite the great therapeutic potential of MSCs, there are still many challenges to their practical application. How to ensure the stable source and controllable quality of MSCs, how to
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