Safety Evaluation of Umbilical Cord Tissue-derived Mesenchymal Stem Cells (UC-MSCs) in the Treatment of Patients With Multiple Sclerosis

Introduction: Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system, leading to symptoms like fatigue, mobility issues, and cognitive decline. Available treatments include disease-modifying therapies (DMTs) and symptom management options. However, many patients experience limited effectiveness, side effects, or inadequate response, highlighting the need for innovative therapeutic approaches. Given the potential of mesenchymal stem cells (MSCs) to modulate immune responses and promote neuroprotection, this study aims to assess safety of umbilical cord-derived MSCs (UC-MSCs), paving the way for future therapeutic applications in MS management.Materials & Methods: In this study, five patients with MS were selected based on McDonald criteria and specific inclusion criteria, including age, EDSS score, and absence of certain medical conditions. Pre-injection assessments included ECG, MRI, and comprehensive blood and urine tests. Patients received UC-MSCs in normal saline over ۲۰ minutes, followed by hydrocortisone. Post-injection, patients were monitored in the hospital for ۲۴-۴۸ hours, with vital signs checked every ۱ to ۳ hours. Blood and urine tests were repeated ۲۴ hours after injection and again one month later to evaluate safety and monitor for adverse effects. Results: Our result showed that the differences in means for all inflammation and infection, liver function, kidney function, and blood tests over the four time points were not statistically significant. Conclusion: Given the absence of significant side effects associated with the utilization of UC-MSCs, it can be confidently concluded that these cells represent a promising therapeutic option for the effective management of MS. Their safety profile enhances their potential as a viable treatment alternative for patients.

کلیدواژه ها:

Umbilical cord tissue ، Mesenchymal stem cells (MSCs) ، Multiple sclerosis ، (MS) ، Safety ، Cell therapy