Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis.
Adverse events
Mesenchymal stem cells
Safety
Systematic review
Journal
EClinicalMedicine
ISSN: 2589-5370
Titre abrégé: EClinicalMedicine
Pays: England
ID NLM: 101733727
Informations de publication
Date de publication:
Feb 2020
Feb 2020
Historique:
received:
15
08
2019
revised:
04
12
2019
accepted:
17
12
2019
entrez:
29
1
2020
pubmed:
29
1
2020
medline:
29
1
2020
Statut:
epublish
Résumé
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. 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. 7473 citations were reviewed and 55 studies met inclusion criteria ( MSC therapy continues to exhibit a favourable safety profile. Future trials should continue to strengthen study rigor, reporting of MSC characterization, and adverse events. Stem Cell Network, Ontario Institute for Regenerative Medicine and Ontario Research Fund.
Sections du résumé
BACKGROUND
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
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
RESULTS
7473 citations were reviewed and 55 studies met inclusion criteria (
INTERPRETATIONS
CONCLUSIONS
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
BACKGROUND
Stem Cell Network, Ontario Institute for Regenerative Medicine and Ontario Research Fund.
Identifiants
pubmed: 31989101
doi: 10.1016/j.eclinm.2019.100249
pii: S2589-5370(19)30258-5
pii: 100249
pmc: PMC6970160
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100249Informations de copyright
© 2019 Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
LM reports grants from CIHR, OIRM and SCN during the conduct of this study. DJS and SHJM reports affiliations with Northern Therapeutics Inc., outside the submitted work. BH reports prior honoraria from Cornerstone Research Group for the provision of methodologic advice related to systematic review and meta-analysis, outside the submitted work. KRW reported grants for CIHR, outside the submitted work. No other authors have any affiliations to report in relation to this study.
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