11. Evaluation of motor function following intervention by umbilical cord-derived mesenchymal stem cells therapy combined with rehabilitation in ischemic stroke patients
Main Article Content
Abstract
The study was conducted to evaluate changes in motor function in patients with ischemic stroke using the Fugl-Meyer Assessment (FMA) following intervention with umbilical cord-derived mesenchymal stem cell (UC-MSC) therapy combined with rehabilitation. This was a Phase I + II clinical trial with a control group, involving 64 patients with ischemic stroke. Participants were divided into two groups: the intervention group (32 patients) received UC-MSC therapy (administered either intravenously or via intrathecal injection) along with rehabilitation training, while the control group (32 patients) received rehabilitation only. Results showed significant improvement in FMA scores within the intervention group at 3, 6, and 12 months post-treatment compared to baseline (p < 0.0001). Additionally, the intervention group exhibited greater improvement in FMA scores than the control group at 6 and 12 months, with statistically significant differences (p < 0.05). No statistically significant difference in FMA scores were observed between the intravenous and intrathecal administration routes.
Article Details
Keywords
Ischemic stroke, umbilical cord-derived mesenchymal stem cells, motor rehabilitation, Fugl-Meyer Assessment
References
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23. Nguyễn Huy Ngọc, Nguyễn Quang Ân, Nguyễn Thị Minh Thanh. Đánh giá kết quả can thiệp vận động cưỡng bức bên liệt cường độ thấp trong phục hồi chức năng chi trên ở người bệnh nhồi máu não giai đoạn cấp tại bệnh viện đa khoa tỉnh Phú Thọ năm 2023. Tạp chí Y học Việt Nam. 2024; 541(1). doi:10.51298/vmj.v541i1.10667.
24. Pandian S, Arya ,Kamal Narayan, and Kumar D. Minimal clinically important difference of the lower-extremity fugl–meyer assessment in chronic-stroke. Top Stroke Rehabil. 2016; 23(4): 233-239. doi:10.1179/1945511915Y.0000000003.
25. Hassanein ME, Fayad J, Shabana JA, et al. Efficacy and safety of intravenous mesenchymal stem cells for ischemic stroke patients, a systematic review and meta-analysis. Front Stroke. 2024; 2. doi:10.3389/fstro.2023.1339331.
26. Sions JM, Tyrell CM, Knarr BA, Jancosko A, Binder-Macleod SA. Age- and stroke-related skeletal muscle changes: a review for the geriatric clinician. J Geriatr Phys Ther 2001. 2012; 35(3): 155-161. doi:10.1519/JPT.0b013e318236db92.
27. Ejma M, Madetko N, Brzecka A, et al. The Role of Stem Cells in the Therapy of Stroke. Curr Neuropharmacol. 2022; 20(3): 630-647. doi:10.2174/1570159X19666210806163352.
28. Chen L, Zhang G, Khan AA, Guo X, Gu Y. Clinical Efficacy and Meta-Analysis of Stem Cell Therapies for Patients with Brain Ischemia. Stem Cells Int. 2016; 2016: 6129579. doi:10.1155/2016/6129579.
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. Demeco A, Zola L, Frizziero A, et al. Immersive Virtual Reality in Post-Stroke Rehabilitation: A Systematic Review. Sensors. 2023; 23(3): 1712. doi:10.3390/s23031712.
4. F X, X L, J X, et al. Emerging Limb Rehabilitation Therapy After Post-stroke Motor Recovery. Front Aging Neurosci. 2022; 14. doi:10.3389/fnagi.2022.863379.
5. Marín-Medina DS, Arenas-Vargas PA, Arias-Botero JC, Gómez-Vásquez M, Jaramillo-López MF, Gaspar-Toro JM. New approaches to recovery after stroke. Neurol Sci Off J Ital Neurol Soc Ital Soc Clin Neurophysiol. 2024; 45(1): 55-63. doi:10.1007/s10072-023-07012-3.
6. Bindawas SM, Vennu VS. Stroke rehabilitation: A call to action in Saudi Arabia. Neurosci J. 2016; 21(4): 297-305. doi:10.17712/nsj.2016.4.20160075.
7. Kawabori M, Shichinohe H, Kuroda S, Houkin K. Clinical Trials of Stem Cell Therapy for Cerebral Ischemic Stroke. Int J Mol Sci. 2020; 21(19): 7380. doi:10.3390/ijms21197380.
8. Cuende N, Rico L, Herrera C. Concise Review: Bone Marrow Mononuclear Cells for the Treatment of Ischemic Syndromes: Medicinal Product or Cell Transplantation? Stem Cells Transl Med. 2012; 1(5): 403-408. doi:10.5966/sctm.2011-0064.
9. Okinaka Y, Kikuchi-Taura A, Takeuchi Y, et al. Clot-Derived Contaminants in Transplanted Bone Marrow Mononuclear Cells Impair the Therapeutic Effect in Stroke. Stroke. 2019; 50(10): 2883-2891. doi:10.1161/STROKEAHA.119.026669.
10. Kawabori M, Shichinohe H, Kuroda S, Houkin K. Clinical Trials of Stem Cell Therapy for Cerebral Ischemic Stroke. Int J Mol Sci. 2020; 21(19): 7380. doi:10.3390/ijms21197380.
11. Li T, Xia M, Gao Y, Chen Y, Xu Y. Human umbilical cord mesenchymal stem cells: An overview of their potential in cell-based therapy. Expert Opin Biol Ther. 2015; 15(9): 1293-1306. doi:10.1517/14712598.2015.1051528.
12. Weiss ML, Anderson C, Medicetty S, et al. Immune Properties of Human Umbilical Cord Wharton’s Jelly-Derived Cells. Stem Cells. 2008; 26(11): 2865-2874. doi:10.1634/stemcells.2007-1028.
13. Xue P, Wang M, Yan G. Mesenchymal stem cell transplantation as an effective treatment strategy for ischemic stroke in Asia: a meta-analysis of controlled trials. Ther Clin Risk Manag. 2018; 14: 909-928. doi:10.2147/TCRM.S161326.
14. Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002; 16(3): 232-240. doi:10.1177/154596802401105171.
15. Kwah LK, Diong J. National Institutes of Health Stroke Scale (NIHSS). J Physiother. 2014; 60(1): 61. doi:10.1016/j.jphys.2013.12.012.
16. Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007; 38(3): 1091-1096. doi:10.1161/01.STR.0000258355.23810.c6.
17. Broderick JP, Adeoye O, Elm J. The Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials. Stroke. 2017; 48(7): 2007-2012. doi:10.1161/STROKEAHA.117.017866.
18. Corrigan JD, Smith-Knapp K, Granger CV. Validity of the functional independence measure for persons with traumatic brain injury. Arch Phys Med Rehabil. 1997; 78(8): 828-834.
19. Ansari NN, Naghdi S, Hasson S, Fakhari Z, Mashayekhi M, Herasi M. Assessing the reliability of the Modified Modified Ashworth Scale between two physiotherapists in adult patients with hemiplegia. NeuroRehabilitation. 2009; 25(4): 235-240. doi:10.3233/NRE-2009-0520.
20. Savitz SI, Yavagal D, Rappard G, et al. A Phase 2 Randomized, Sham-Controlled Trial of Internal Carotid Artery Infusion of Autologous Bone Marrow–Derived ALD-401 Cells in Patients With Recent Stable Ischemic Stroke (RECOVER-Stroke). Circulation. 2019; 139(2): 192-205. doi:10.1161/CIRCULATIONAHA.117.030659.
21. Shanghai IxCell Biotechnology Co., LTD. A Phase I Study of Safety and Tolerability of Single-Dose Human Umbilical Cord Mesenchymal Stem Cell (IxCell hUC-MSC-S) in Patients With Convalescent Phase of Ischemic Stroke. clinicaltrials.gov; 2024. Accessed February 2, 2025. https://clinicaltrials.gov/study/NCT05697718.
22. Savitz S. SAfety of Mesenchymal Stromal Cells for Ischemic Stroke. clinicaltrials.gov; 2018. Accessed February 2, 2025. https://clinicaltrials.gov/study/NCT01922908.
23. Nguyễn Huy Ngọc, Nguyễn Quang Ân, Nguyễn Thị Minh Thanh. Đánh giá kết quả can thiệp vận động cưỡng bức bên liệt cường độ thấp trong phục hồi chức năng chi trên ở người bệnh nhồi máu não giai đoạn cấp tại bệnh viện đa khoa tỉnh Phú Thọ năm 2023. Tạp chí Y học Việt Nam. 2024; 541(1). doi:10.51298/vmj.v541i1.10667.
24. Pandian S, Arya ,Kamal Narayan, and Kumar D. Minimal clinically important difference of the lower-extremity fugl–meyer assessment in chronic-stroke. Top Stroke Rehabil. 2016; 23(4): 233-239. doi:10.1179/1945511915Y.0000000003.
25. Hassanein ME, Fayad J, Shabana JA, et al. Efficacy and safety of intravenous mesenchymal stem cells for ischemic stroke patients, a systematic review and meta-analysis. Front Stroke. 2024; 2. doi:10.3389/fstro.2023.1339331.
26. Sions JM, Tyrell CM, Knarr BA, Jancosko A, Binder-Macleod SA. Age- and stroke-related skeletal muscle changes: a review for the geriatric clinician. J Geriatr Phys Ther 2001. 2012; 35(3): 155-161. doi:10.1519/JPT.0b013e318236db92.
27. Ejma M, Madetko N, Brzecka A, et al. The Role of Stem Cells in the Therapy of Stroke. Curr Neuropharmacol. 2022; 20(3): 630-647. doi:10.2174/1570159X19666210806163352.
28. Chen L, Zhang G, Khan AA, Guo X, Gu Y. Clinical Efficacy and Meta-Analysis of Stem Cell Therapies for Patients with Brain Ischemia. Stem Cells Int. 2016; 2016: 6129579. doi:10.1155/2016/6129579.