ISSN: 1859 - 2872
Significant improvement of Barthel index scores in patients with subacute middle cerebral artery infarct after intravenous autologous bone marrow-derived stem cells infusion
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Objective: To assess the safety and the efficacy of intravenous infusion of autologous bone marrow-derived stem cells (BMSC) in subacute middle cerebral artery (MCA) infarct. Subject and method: A prospective, open-label, non-randomized was performed in patients with MCA infarct, within 7-40 days from onset. Sixty-three patients, satisfying the inclusion criteria, were enrolled, and allocated into the IV-BMSC group (n = 32) or into control group (n = 31). Main follow-ups were at 6 months and 1 year after therapy. Adverse events were noted to conclude safety outcome. The primary efficacy outcomes were proportions of patients achieving a score of 0 to 2 on the modified Rankin Scale (mRS). The secondary efficacy outcomes were evaluated by the National Institutes of Health Stroke Scale (NIHSS), Barthel index (BI), Brunnstrom stages of hand (BRS-H), and infarct volume on head MRI. Result: There were no statistically significant differences in the rates of noted adverse events. There were no significant differences between the two groups on the proportions of the mRS 0-2 at both 6-month and 1-year follow-up (3.2% vs 6.9% with p=0.6, and 6.9 vs 9.7 with p=1.0, respectively). The improvement of BI at 6 months was significantly better in the IV-BMSC group compared to control group, however no significant differences on other secondary efficacy measures. Conclusion: Intravenous infusion of BMSC was safe in patients with subacute MCA infarct. Although the difference in the primary efficacy outcomes was not statistically significant, a favorable secondary outcome was observed in IV-BMSC group, presenting by the statistically significant improvement of the Barthel index at 6-month follow-up.
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2. Rodríguez-Frutos B, Otero-Ortega L, Gutiérrez-Fernández M, Fuentes B, Ramos-Cejudo J, Díez-Tejedor E (2016) Stem cell therapy and administration routes after stroke. Translational Stroke Research 7(5): 378-387.
3. Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al (1989) Measurements of acute cerebral infarction: A clinical examination scale. Stroke 20(7): 864-870.
4. Mahoney FI and Barthel DW (1965) Functional evaluation: the barthel index. Md State Med J 14: 61-65.
5. Bruno A, Akinwuntan AE, Lin C, Close B, Davis K, Baute V, Aryal T, Brooks D, Hess DC, Switzer JA, Nichols FT (2011) Simplified modified rankin scale questionnaire: Reproducibility over the telephone and validation with quality of life. Stroke 42(8): 2276-2279.
6. Saver JL, Chaisinanunkul N, Campbell BCV et al (2021) Standardized nomenclature for Modified Rankin Scale global disability outcomes: Consensus Recommendations From Stroke Therapy Academic Industry Roundtable XI. Stroke 52(9): 3054-3062.
7. Pandian S, Arya KN, Davidson EWR (2012) Comparison of Brunnstrom movement therapy and motor relearning program in rehabilitation of post-stroke hemiparetic hand: A randomized trial. Journal of Bodywork and Movement Therapies 16(3): 330-337.
8. Sims JR, Gharai LR, Schaefer PW, Vangel M, Rosenthal ES, Lev MH, Schwamm LH (2009) ABC/2 for rapid clinical estimate of infarct, perfusion, and mismatch volumes. Neurology 72(24): 2104-2110.
9. Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, McTaggart RA, Torbey MT, Kim-Tenser M, Leslie-Mazwi T, Sarraj A, Kasner SE, Ansari SA, Yeatts SD, Hamilton S, Mlynash M, Heit JJ, Zaharchuk G, Kim S, Carrozzella J, Palesch YY, Demchuk AM, Bammer R, Lavori PW, Broderick JP, Lansberg MG; DEFUSE 3 Investigators (2018) Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 378(8): 708-718. doi: 10.1056/NEJMoa1713973.
10. Jovin TG, Chamorro A, Cobo E et al (2015) Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med 372(24): 2296-306. doi: 10.1056/NEJMoa1503780.
11. Hess DC, Wechsler LR, Clark WM, Savitz SI, Ford GA, Chiu D, Yavagal DR, Uchino K, Liebeskind DS, Auchus AP, Sen S, Sila CA, Vest JD, Mays RW (2017) Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol 16(5): 360-368.
12. Jaillard A, Hommel M, Moisan A, Zeffiro TA, Favre-Wiki IM, Barbieux-Guillot M, Vadot W, Marcel S, Lamalle L, Grand S, Detante O (2020) Autologous mesenchymal stem cells improve motor recovery in subacute ischemic stroke: A randomized clinical trial. Transl Stroke Res 11(5): 910-923.
13. Prasad K, Sharma A, Garg A, Mohanty S, Bhatnagar S, Johri S, Singh KK, Nair V, Sarkar RS, Gorthi SP, Hassan KM, Prabhakar S, Marwaha N, Khandelwal N, Misra UK, Kalita J, Nityanand S; InveST Study Group (2014) Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke: A multicentric, randomized trial. Stroke 45(12): 3618-3624.
14. Law ZK, Tan HJ, Chin SP, Wong CY, Wan Yahya WNN, Muda AS, Zakaria R, Ariff MI, Ismail NA, Cheong SK, S Abdul Wahid SF, Mohamed Ibrahim N (2021) The effects of intravenous infusion of autologous mesenchymal stromal cells in patients with subacute middle cerebral artery infarct: a phase 2 randomized controlled trial on safety, tolerability and efficacy. Cytotherapy 23(9): 833-840.
15. Lee J, Chang WH, Chung JW, Kim SJ, Kim SK, Lee JS, Sohn SI, Kim YH, Bang OY; STARTING-2 Collaborators (2022) Efficacy of intravenous mesenchymal stem cells for motor recovery after ischemic stroke: A neuroimaging study. Stroke 53(1): 20-28.
16. Savitz SI, Yavagal D, Rappard G, Likosky W, Rutledge N, Graffagnino C, Alderazi Y, Elder JA, Chen PR, Budzik RF Jr, Tarrel R, Huang DY, Hinson JM Jr (2019) 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 139(2): 192-205.
17. Rothrock JF, Clark WM, and Lyden PD (1995) Spontaneous early improvement following ischemic stroke. Stroke 26(8): 1358-1360. doi: 10.1161/01.str.26.8.1358.
18. Walcott BP, Miller JC, Kwon CS, Sheth SA, Hiller M, Cronin CA, Schwamm LH, Simard JM, Kahle KT, Kimberly WT, Sheth KN (2014) Outcomes in severe middle cerebral artery ischemic stroke. Neurocrit Care 21(1): 20-26.
19. Li L, Jiang Q, Ding G, Zhang L, Zhang ZG, Li Q, Panda S, Lu M, Ewing JR, Chopp M (2010) Effects of administration route on migration and distribution of neural progenitor cells transplanted into rats with focal cerebral ischemia, an MRI study. J Cereb Blood Flow Metab 30(3): 653-662.
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