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Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis

Open access
Thompson, Mary, Mei, Shirley H.J., Wolfe, Dianna, Champagne, Josée, Fergusson, Dean, Stewart, Duncan J., Sullivan, Katrina J., Doxtator, Emily, Lalu, Manoj, English, Shane W., Granton, John, Hutton, Brian, Marshall, John, Maybee, Alies, Walley, Keith R., Santos, Claudia Dos, Winston, Brent, McIntyre, Lauralyn·2020·EClinicalMedicine

Abstract

BACKGROUND: Characterization of the mesenchymal stromal cell (MSC) safety profile is important as this novel therapy continues to be evaluated in clinical trials for various inflammatory conditions. Due to an increase in published randomized controlled trials (RCTs) from 2012-2019, we performed an updated systematic review to further characterize the MSC safety profile. METHODS: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Web of Science (to May 2018) were searched. RCTs that compared intravascular delivery of MSCs to controls in adult populations were included. Pre-specified adverse events were grouped according to: (1) immediate, (2) infection, (3) thrombotic/embolic, and (4) longer-term events (mortality, malignancy). Adverse events were pooled and meta-analyzed by fitting inverse-variance binary random effects models. Primary and secondary clinical efficacy endpoints were summarized descriptively. FINDINGS: = 0%, 0%, 0%, 0%, 0%). No included trials were ended prematurely due to safety concerns. INTERPRETATIONS: MSC therapy continues to exhibit a favourable safety profile. Future trials should continue to strengthen study rigor, reporting of MSC characterization, and adverse events. FUNDING: Stem Cell Network, Ontario Institute for Regenerative Medicine and Ontario Research Fund.

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Metadata

Authors
Thompson, M., Mei, S. H. J., Wolfe, D., Champagne, J., Fergusson, D., Stewart, D. J., Sullivan, K. J., Doxtator, E., Lalu, M., English, S. W., Granton, J., Hutton, B., Marshall, J., Maybee, A., Walley, K. R., Santos, C. D., Winston, B., & McIntyre, L.
Venue
EClinicalMedicine
Publisher
Elsevier BV
Published
2020-02
Volume
19
Pages
100249
ISSN
2589-5370 (ISSN-L)
OpenAlex
W2999396804
Cited by
283
References
59
FWCI
9.29
Type
journal article
Language
en
Open access
gold

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Thompson, M., Mei, S. H. J., Wolfe, D., Champagne, J., Fergusson, D., Stewart, D. J., Sullivan, K. J., Doxtator, E., Lalu, M., English, S. W., Granton, J., Hutton, B., Marshall, J., Maybee, A., Walley, K. R., Santos, C. D., Winston, B., & McIntyre, L. (2020). Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis. EClinicalMedicine. https://doi.org/10.1016/j.eclinm.2019.100249

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.