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Published: 2023-09-20
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DOI: https://doi.org/10.52852/tcncyh.v169i8.1814
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Vol. 169 No. 8 (2023)
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Các bài báo
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Thuỷ, N. T. N., Lâm, P. N., Đoan, N. V., Hương, L. T., Anh, N. T. P., Bích, P. T., Kiên, N. T., Đức, H. M., Anh, N. Q., Hà, N. T. V., Minh, P. V., & Liêm, N. T. (2023). 10. Safety assessment of umbilical cord mesenchymal stem cell transplantation in combination with rehabilitation in ischemic stroke patients. Journal of Medical Research, 169(8), 80-88. https://doi.org/10.52852/tcncyh.v169i8.1814

10. Safety assessment of umbilical cord mesenchymal stem cell transplantation in combination with rehabilitation in ischemic stroke patients

Nguyen Thi Ngoc Thuy, Phung Nam Lam, Ngo Van Doan, Le Thu Huong, Nguyen Thi Phuong Anh, Pham Thi Bich, Nguyen Trung Kien, Hoang Minh Duc, Nguyen Quang Anh, Nguyen Thi Viet Ha, Pham Van Minh, Nguyen Thanh Liem

Main Article Content

Abstract

Umbilical cord mesenchymal stem cell therapy (UC-MSC) is evaluated as a potential and effective for brain recovering in the treatment of neurological diseases, including ischemic stroke. The study was conducted to evaluate the safety of UC-MSC therapy through two intravenous and intrathecal administration in the ischemic stroke patients. The method was a phase I clinical trial in 10 ischemic stroke patients, assessing safety through the occurrence of adverse events (AEs), serious adverse events (SAEs) and initial results through NIHSS and FIM at 3 months, 6 months and 12 months. The results showed that there was none of any SAEs, there were 4 AEs in the intravenous group and 6 AEs in the intrathecal group and there was an improvement in NIHSS score and FIM score after 12 months of intervention. We concluded that UC-MSC therapy is safe and initially effective in improving neurological sequelae after ischemic stroke, as such it is necessary to transition to phase II to further evaluate the UC-MSC effectiveness.

Article Details

Keywords

Ischemic stroke- umbilical cord mesenchymal cell therapy- clinical trial- safety

References

1. Deng L, Peng Q, Wang H, et al. Intrathecal Injection of Allogenic Bone Marrow-Derived Mesenchymal Stromal Cells in Treatment of Patients with Severe Ischemic Stroke: Study Protocol for a Randomized Controlled Observer-Blinded Trial. Transl Stroke Res. 2019; 10(2): 170-177. doi:10.1007/s12975-018-0634-y.
2. Le Danseur M. Stroke Rehabilitation. Crit Care Nurs Clin North Am. 2020; 32(1): 97-108. doi:10.1016/j.cnc.2019.11.004.
3. Chương trình Avant Phục hồi chức năng thần kinh sau đột quỵ não. Tài liệu lý thuyết rối loạn vận động và rối loạn nuốt. Published online 2007.
4. Brooks B, Ebedes D, Usmani A, Gonzales-Portillo JV, Gonzales-Portillo D, Borlongan CV. Mesenchymal Stromal Cells in Ischemic Brain Injury. Cells. 2022; 11(6): 1013. doi:10.3390/cells11061013.
5. Eckert MA, Vu Q, Xie K, et al. Evidence for high translational potential of mesenchymal stromal cell therapy to improve recovery from ischemic stroke. J Cereb Blood Flow Metab Off J Int Soc Cereb Blood Flow Metab. 2013; 33(9): 1322-1334. doi:10.1038/jcbfm.2013.91.
6. Hsuan YCY, Lin CH, Chang CP, Lin MT. Mesenchymal stem cell-based treatments for stroke, neural trauma, and heat stroke. Brain Behav. 2016; 6(10): e00526. doi:10.1002/brb3.526.
7. Li Z, Dong X, Tian M, et al. Stem cell-based therapies for ischemic stroke: a systematic review and meta-analysis of clinical trials. Stem Cell Res Ther. 2020; 11(1): 252. doi:10.1186/s13287-020-01762-z.
8. Hoang DM, Nguyen QT, Phan TTK, et al. Advanced cell-based products generated via automated and manual manufacturing platforms under the quality by design principle: Are they equivalent or different? Heliyon. 2023; 9(5): e15946. doi:10.1016/j.heliyon.2023.e15946.
9. Hoang VT, Trinh QM, Phuong DTM, et al. Standardized xeno- and serum-free culture platform enables large-scale expansion of high-quality mesenchymal stem/stromal cells from perinatal and adult tissue sources. Cytotherapy. 2021; 23(1): 88-99. doi:10.1016/j.jcyt.2020.09.004.
10. Li Z, Dong X, Tian M, et al. Stem cell-based therapies for ischemic stroke: a systematic review and meta-analysis of clinical trials. Stem Cell Res Ther. 2020; 11: 252. doi:10.1186/s13287-020-01762-z.
11. Lee JS, Hong JM, Moon GJ, et al. A long-term follow-up study of intravenous autologous mesenchymal stem cell transplantation in patients with ischemic stroke. Stem Cells Dayt Ohio. 2010; 28(6): 1099-1106. doi:10.1002/stem.430.
12. Bhatia V, Gupta V, Khurana D, Sharma RR, Khandelwal N. Randomized Assessment of the Safety and Efficacy of Intra-Arterial Infusion of Autologous Stem Cells in Subacute Ischemic Stroke. AJNR Am J Neuroradiol. 2018; 39(5): 899-904. doi:10.3174/ajnr.A5586.
13. Jin Y, Ying L, Yu G, Nan G. Analysis of the long-term effect of bone marrow mononuclear cell transplantation for the treatment of cerebral infarction. Int J Clin Exp Med. 2017; 10: 3059-3068.
14. Ghali AA, Yousef MK, Ragab OA, ElZamarany EA. Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Stem Cells in Subacute Ischemic Stroke Patients. Front Neurol. 2016; 7: 228. doi:10.3389/fneur.2016.00228.
15. Moniche F, Gonzalez A, Gonzalez-Marcos JR, et al. Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke. 2012; 43(8): 2242-2244. doi:10.1161/STROKEAHA.112.659409.