Probable Factors Associated with Response to Mesenchymal Stem Cell Therapy in Stroke Patients: A Post Hoc Analysis of the STARTING-2 Trial

The aim of this study was to identify factors associated with improved motor function of the lower extremities in response to mesenchymal stem cell (MSC) therapy in patients with ischemic stroke. This study was a post hoc analysis of data from a prospective, open-label, randomized controlled trial o...

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Main Authors: Won Hyuk Chang, Jungsoo Lee, Jong-Won Chung, Yun-Hee Kim, Oh Young Bang, The STARTING-2 Collaborators
Format: Article
Language:English
Published: MDPI AG 2021-11-01
Series:Journal of Personalized Medicine
Subjects:
Online Access:https://www.mdpi.com/2075-4426/11/11/1137
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author Won Hyuk Chang
Jungsoo Lee
Jong-Won Chung
Yun-Hee Kim
Oh Young Bang
The STARTING-2 Collaborators
author_facet Won Hyuk Chang
Jungsoo Lee
Jong-Won Chung
Yun-Hee Kim
Oh Young Bang
The STARTING-2 Collaborators
author_sort Won Hyuk Chang
collection DOAJ
description The aim of this study was to identify factors associated with improved motor function of the lower extremities in response to mesenchymal stem cell (MSC) therapy in patients with ischemic stroke. This study was a post hoc analysis of data from a prospective, open-label, randomized controlled trial of MSC therapy for patients with ischemic stroke patients associated with severe middle cerebral artery territory (STARTING-2 trial). Lower limb motor function was scored based on the lower limb of Fugl–Meyer assessment (FMA-LL) score before MSC therapy and at 3 months after stroke. All FMA-LL changes greater than or equal to six points were considered clinically significant. Univariate and multivariate binary logistic regression models were used to determine possible predictors of clinically significant lower limb motor response to MSC therapy. Twelve (33%) of the thirty-six patients receiving MSC therapy reached a minimal clinically important difference (MCID) of FMA-LL. The two independent factors with the greatest impact on response to MSC therapy for achieving an MCID in FMA-LL score were: (1) the time from stroke onset to MSC therapy, and (2) age (<i>p</i> < 0.05). In addition, obese stroke patients responded better to MSC therapy than stroke patients with normal weight. In conclusion, this post hoc analysis might suggest the need for recruiting stroke patients at younger and early after stroke onset in future clinical trials of MSC therapy for stroke.
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spelling doaj.art-a80a79b6f65f4a5f9024672142dad6662023-11-22T23:58:28ZengMDPI AGJournal of Personalized Medicine2075-44262021-11-011111113710.3390/jpm11111137Probable Factors Associated with Response to Mesenchymal Stem Cell Therapy in Stroke Patients: A Post Hoc Analysis of the STARTING-2 TrialWon Hyuk Chang0Jungsoo Lee1Jong-Won Chung2Yun-Hee Kim3Oh Young Bang4The STARTING-2 Collaborators5Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, KoreaDepartment of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, KoreaDepartments of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, KoreaDepartment of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, KoreaDepartments of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, KoreaDepartments of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, KoreaThe aim of this study was to identify factors associated with improved motor function of the lower extremities in response to mesenchymal stem cell (MSC) therapy in patients with ischemic stroke. This study was a post hoc analysis of data from a prospective, open-label, randomized controlled trial of MSC therapy for patients with ischemic stroke patients associated with severe middle cerebral artery territory (STARTING-2 trial). Lower limb motor function was scored based on the lower limb of Fugl–Meyer assessment (FMA-LL) score before MSC therapy and at 3 months after stroke. All FMA-LL changes greater than or equal to six points were considered clinically significant. Univariate and multivariate binary logistic regression models were used to determine possible predictors of clinically significant lower limb motor response to MSC therapy. Twelve (33%) of the thirty-six patients receiving MSC therapy reached a minimal clinically important difference (MCID) of FMA-LL. The two independent factors with the greatest impact on response to MSC therapy for achieving an MCID in FMA-LL score were: (1) the time from stroke onset to MSC therapy, and (2) age (<i>p</i> < 0.05). In addition, obese stroke patients responded better to MSC therapy than stroke patients with normal weight. In conclusion, this post hoc analysis might suggest the need for recruiting stroke patients at younger and early after stroke onset in future clinical trials of MSC therapy for stroke.https://www.mdpi.com/2075-4426/11/11/1137mesenchymal stem cellsstrokemotor recoverypost hoc analysismotor impairment
spellingShingle Won Hyuk Chang
Jungsoo Lee
Jong-Won Chung
Yun-Hee Kim
Oh Young Bang
The STARTING-2 Collaborators
Probable Factors Associated with Response to Mesenchymal Stem Cell Therapy in Stroke Patients: A Post Hoc Analysis of the STARTING-2 Trial
Journal of Personalized Medicine
mesenchymal stem cells
stroke
motor recovery
post hoc analysis
motor impairment
title Probable Factors Associated with Response to Mesenchymal Stem Cell Therapy in Stroke Patients: A Post Hoc Analysis of the STARTING-2 Trial
title_full Probable Factors Associated with Response to Mesenchymal Stem Cell Therapy in Stroke Patients: A Post Hoc Analysis of the STARTING-2 Trial
title_fullStr Probable Factors Associated with Response to Mesenchymal Stem Cell Therapy in Stroke Patients: A Post Hoc Analysis of the STARTING-2 Trial
title_full_unstemmed Probable Factors Associated with Response to Mesenchymal Stem Cell Therapy in Stroke Patients: A Post Hoc Analysis of the STARTING-2 Trial
title_short Probable Factors Associated with Response to Mesenchymal Stem Cell Therapy in Stroke Patients: A Post Hoc Analysis of the STARTING-2 Trial
title_sort probable factors associated with response to mesenchymal stem cell therapy in stroke patients a post hoc analysis of the starting 2 trial
topic mesenchymal stem cells
stroke
motor recovery
post hoc analysis
motor impairment
url https://www.mdpi.com/2075-4426/11/11/1137
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