Staff View: 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

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

Background aims Mesenchymal stromal cells (MSCs) are characterized by paracrine and immunomodulatory functions capable of changing the microenvironment of damaged brain tissue toward a more regenerative and less inflammatory milieu. The authors conducted a phase 2, single-center, assessor-blinded ra...

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Main Authors:	Zhe, Kang Law, Hui, Jan Tan, Sze, Piaw Chin, Chee, Yin Wong, Wan Yahya, Wan Nur Nafisah, Muda, Ahmad Sobri, Zakaria, Rozman, Ariff, Mohd Izhar, Ismail, Nor Azimah, Soon, Keng Cheong, S. Abdul Wahid, S. Fadilah, Mohamed Ibrahim, Norlinah
Format:	Article
Language:	English
Published:	Elsevier 2021
Online Access:	http://psasir.upm.edu.my/id/eprint/95417/1/The%20effects%20of%20intravenous%20infusion%20of%20autologous%20mesenchymal%20stromal%20cells%20in%20patients%20with%20subacute%20middle%20cerebral%20artery%20infarct%20a%20phase%202%20randomized%20controlled%20trial%20on%20safety%2C%20tolerability%20and%20efficacy.pdf http://psasir.upm.edu.my/id/eprint/95417/ https://www.sciencedirect.com/science/article/pii/S1465324921002140
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spelling	my.upm.eprints.954172023-01-05T06:59:12Z http://psasir.upm.edu.my/id/eprint/95417/ 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 Zhe, Kang Law Hui, Jan Tan Sze, Piaw Chin Chee, Yin Wong Wan Yahya, Wan Nur Nafisah Muda, Ahmad Sobri Zakaria, Rozman Ariff, Mohd Izhar Ismail, Nor Azimah Soon, Keng Cheong S. Abdul Wahid, S. Fadilah Mohamed Ibrahim, Norlinah Background aims Mesenchymal stromal cells (MSCs) are characterized by paracrine and immunomodulatory functions capable of changing the microenvironment of damaged brain tissue toward a more regenerative and less inflammatory milieu. The authors conducted a phase 2, single-center, assessor-blinded randomized controlled trial to investigate the safety and efficacy of intravenous autologous bone marrow-derived MSCs (BMMSCs) in patients with subacute middle cerebral artery (MCA) infarct. Methods Patients aged 30-75 years who had severe ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 10-35) involving the MCA territory were recruited within 2 months of stroke onset. Using permuted block randomization, patients were assigned to receive 2 million BMMSCs per kilogram of body weight (treatment group) or standard medical care (control group). The primary outcomes were the NIHSS, modified Rankin Scale (mRS), Barthel Index (BI) and total infarct volume on brain magnetic resonance imaging (MRI) at 12 months. All outcome assessments were performed by blinded assessors. Per protocol, analyses were performed for between-group comparisons. Results Seventeen patients were recruited. Nine were assigned to the treatment group, and eight were controls. All patients were severely disabled following their MCA infarct (median mRS = 4.0 [4.0-5.0], BI = 5.0 [5.0-25.0], NIHSS = 16.0 [11.5-21.0]). The baseline infarct volume on the MRI was larger in the treatment group (median, 71.7 [30.5-101.7] mL versus 26.7 [12.9-75.3] mL, P = 0.10). There were no between-group differences in median NIHSS score (7.0 versus 6.0, P = 0.96), mRS (2.0 versus 3.0, P = 0.38) or BI (95.0 versus 67.5, P = 0.33) at 12 months. At 12 months, there was significant improvement in absolute change in median infarct volume, but not in total infarct volume, from baseline in the treatment group (P = 0.027). No treatment-related adverse effects occurred in the BMMSC group. Conclusions Intravenous infusion of BMMSCs in patients with subacute MCA infarct was safe and well tolerated. Although there was no neurological recovery or functional outcome improvement at 12 months, there was improvement in absolute change in median infarct volume in the treatment group. Larger, well-designed studies are warranted to confirm this and the efficacy of BMMSCs in ischemic stroke. Elsevier 2021-09 Article PeerReviewed text en http://psasir.upm.edu.my/id/eprint/95417/1/The%20effects%20of%20intravenous%20infusion%20of%20autologous%20mesenchymal%20stromal%20cells%20in%20patients%20with%20subacute%20middle%20cerebral%20artery%20infarct%20a%20phase%202%20randomized%20controlled%20trial%20on%20safety%2C%20tolerability%20and%20efficacy.pdf Zhe, Kang Law and Hui, Jan Tan and Sze, Piaw Chin and Chee, Yin Wong and Wan Yahya, Wan Nur Nafisah and Muda, Ahmad Sobri and Zakaria, Rozman and Ariff, Mohd Izhar and Ismail, Nor Azimah and Soon, Keng Cheong and S. Abdul Wahid, S. Fadilah and Mohamed Ibrahim, Norlinah (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. ISSN 1465-3249; ESSN: 1477-2566 https://www.sciencedirect.com/science/article/pii/S1465324921002140 10.1016/j.jcyt.2021.03.005
institution	Universiti Putra Malaysia
building	UPM Library
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	Universiti Putra Malaysia
content_source	UPM Institutional Repository
url_provider	http://psasir.upm.edu.my/
language	English
description	Background aims Mesenchymal stromal cells (MSCs) are characterized by paracrine and immunomodulatory functions capable of changing the microenvironment of damaged brain tissue toward a more regenerative and less inflammatory milieu. The authors conducted a phase 2, single-center, assessor-blinded randomized controlled trial to investigate the safety and efficacy of intravenous autologous bone marrow-derived MSCs (BMMSCs) in patients with subacute middle cerebral artery (MCA) infarct. Methods Patients aged 30-75 years who had severe ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 10-35) involving the MCA territory were recruited within 2 months of stroke onset. Using permuted block randomization, patients were assigned to receive 2 million BMMSCs per kilogram of body weight (treatment group) or standard medical care (control group). The primary outcomes were the NIHSS, modified Rankin Scale (mRS), Barthel Index (BI) and total infarct volume on brain magnetic resonance imaging (MRI) at 12 months. All outcome assessments were performed by blinded assessors. Per protocol, analyses were performed for between-group comparisons. Results Seventeen patients were recruited. Nine were assigned to the treatment group, and eight were controls. All patients were severely disabled following their MCA infarct (median mRS = 4.0 [4.0-5.0], BI = 5.0 [5.0-25.0], NIHSS = 16.0 [11.5-21.0]). The baseline infarct volume on the MRI was larger in the treatment group (median, 71.7 [30.5-101.7] mL versus 26.7 [12.9-75.3] mL, P = 0.10). There were no between-group differences in median NIHSS score (7.0 versus 6.0, P = 0.96), mRS (2.0 versus 3.0, P = 0.38) or BI (95.0 versus 67.5, P = 0.33) at 12 months. At 12 months, there was significant improvement in absolute change in median infarct volume, but not in total infarct volume, from baseline in the treatment group (P = 0.027). No treatment-related adverse effects occurred in the BMMSC group. Conclusions Intravenous infusion of BMMSCs in patients with subacute MCA infarct was safe and well tolerated. Although there was no neurological recovery or functional outcome improvement at 12 months, there was improvement in absolute change in median infarct volume in the treatment group. Larger, well-designed studies are warranted to confirm this and the efficacy of BMMSCs in ischemic stroke.
format	Article
author	Zhe, Kang Law Hui, Jan Tan Sze, Piaw Chin Chee, Yin Wong Wan Yahya, Wan Nur Nafisah Muda, Ahmad Sobri Zakaria, Rozman Ariff, Mohd Izhar Ismail, Nor Azimah Soon, Keng Cheong S. Abdul Wahid, S. Fadilah Mohamed Ibrahim, Norlinah
spellingShingle	Zhe, Kang Law Hui, Jan Tan Sze, Piaw Chin Chee, Yin Wong Wan Yahya, Wan Nur Nafisah Muda, Ahmad Sobri Zakaria, Rozman Ariff, Mohd Izhar Ismail, Nor Azimah Soon, Keng Cheong S. Abdul Wahid, S. Fadilah Mohamed Ibrahim, Norlinah 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
author_facet	Zhe, Kang Law Hui, Jan Tan Sze, Piaw Chin Chee, Yin Wong Wan Yahya, Wan Nur Nafisah Muda, Ahmad Sobri Zakaria, Rozman Ariff, Mohd Izhar Ismail, Nor Azimah Soon, Keng Cheong S. Abdul Wahid, S. Fadilah Mohamed Ibrahim, Norlinah
author_sort	Zhe, Kang Law
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	Elsevier
publishDate	2021
url	http://psasir.upm.edu.my/id/eprint/95417/1/The%20effects%20of%20intravenous%20infusion%20of%20autologous%20mesenchymal%20stromal%20cells%20in%20patients%20with%20subacute%20middle%20cerebral%20artery%20infarct%20a%20phase%202%20randomized%20controlled%20trial%20on%20safety%2C%20tolerability%20and%20efficacy.pdf http://psasir.upm.edu.my/id/eprint/95417/ https://www.sciencedirect.com/science/article/pii/S1465324921002140
_version_	1754531217097621504
score	13.211869

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

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