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Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke

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Author(s)
Jong-Won ChungWon Hyuk ChangOh Young BangGyeong Joon MoonSuk Jae KimSoo-Kyoung KimJin Soo LeeSung-Il SohnYun-Hee Kim
Keimyung Author(s)
Sohn, Sung Il
Department
Dept. of Neurology (신경과학)
Journal Title
Neurology
Issued Date
2021
Volume
96
Issue
7
Abstract
Objective:
To test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.

Methods:
In this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.

Results:
A total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range 28–83) years, and mean interval between stroke onset to randomization was 20.2 (range 5–89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months (p = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index, p = 0.023), which was notable among patients with low predicted recovery potential. There were no serious treatment-related adverse events.

Conclusions:
IV application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.

Classification of Evidence:
This study provides Class III evidence that autologous MSCs do not improve 90-day outcomes in patients with chronic stroke.
Keimyung Author(s)(Kor)
손성일
Publisher
School of Medicine (의과대학)
Citation
Jong-Won Chung et al. (2021). Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke. Neurology, 96(7), e1012–e1023. doi: 10.1212/WNL.0000000000011440
Type
Article
ISSN
1526-632X
Source
https://n.neurology.org/content/96/7/e1012.long
DOI
10.1212/WNL.0000000000011440
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43641
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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