Effect of once versus twice intracoronary injection of allogeneic-derived mesenchymal stromal cells after acute myocardial infarction: BOOSTER-TAHA7 randomized clinical trial.
Intracoronary injection
Mesenchymal stromal cell
Myocardial infarction
Stroke volume
Ventricular function
Journal
Stem cell research & therapy
ISSN: 1757-6512
Titre abrégé: Stem Cell Res Ther
Pays: England
ID NLM: 101527581
Informations de publication
Date de publication:
23 09 2023
23 09 2023
Historique:
received:
09
04
2023
accepted:
12
09
2023
medline:
25
9
2023
pubmed:
23
9
2023
entrez:
22
9
2023
Statut:
epublish
Résumé
Mesenchymal stromal cell (MSC) transplantation can improve the left ventricular ejection fraction (LVEF) after an acute myocardial infarction (AMI). Transplanted MSCs exert a paracrine effect, which might be augmented if repeated doses are administered. This study aimed to compare the effects of single versus double transplantation of Wharton's jelly MSCs (WJ-MSCs) on LVEF post-AMI. We conducted a single-blind, randomized, multicenter trial. After 3-7 days of an AMI treated successfully by primary PCI, 70 patients younger than 65 with LVEF < 40% on baseline echocardiography were randomized to receive conventional care, a single intracoronary infusion of WJ-MSCs, or a repeated infusion 10 days later. The primary endpoint was the 6-month LVEF improvement as per cardiac magnetic resonance (CMR) imaging. The mean baseline EF measured by CMR was similar (~ 40%) in all three groups. By the end of the trial, while all patients experienced a rise in EF, the most significant change was seen in the repeated intervention group. Compared to the control group (n = 25), single MSC transplantation (n = 20) improved the EF by 4.54 ± 2%, and repeated intervention (n = 20) did so by 7.45 ± 2% when measured by CMR imaging (P < 0.001); when evaluated by echocardiography, these values were 6.71 ± 2.4 and 10.71 ± 2.5%, respectively (P < 0.001). Intracoronary transplantation of WJ-MSCs 3-7 days after AMI in selected patients significantly improves LVEF, with the infusion of a booster dose 10 days later augmenting this effect. Trial registration: Iranian Registry of Clinical Trials, IRCT20201116049408N1. Retrospectively Registered 20 Nov. 2020, https://en.irct.ir/trial/52357.
Sections du résumé
BACKGROUND
Mesenchymal stromal cell (MSC) transplantation can improve the left ventricular ejection fraction (LVEF) after an acute myocardial infarction (AMI). Transplanted MSCs exert a paracrine effect, which might be augmented if repeated doses are administered. This study aimed to compare the effects of single versus double transplantation of Wharton's jelly MSCs (WJ-MSCs) on LVEF post-AMI.
METHODS
We conducted a single-blind, randomized, multicenter trial. After 3-7 days of an AMI treated successfully by primary PCI, 70 patients younger than 65 with LVEF < 40% on baseline echocardiography were randomized to receive conventional care, a single intracoronary infusion of WJ-MSCs, or a repeated infusion 10 days later. The primary endpoint was the 6-month LVEF improvement as per cardiac magnetic resonance (CMR) imaging.
RESULTS
The mean baseline EF measured by CMR was similar (~ 40%) in all three groups. By the end of the trial, while all patients experienced a rise in EF, the most significant change was seen in the repeated intervention group. Compared to the control group (n = 25), single MSC transplantation (n = 20) improved the EF by 4.54 ± 2%, and repeated intervention (n = 20) did so by 7.45 ± 2% when measured by CMR imaging (P < 0.001); when evaluated by echocardiography, these values were 6.71 ± 2.4 and 10.71 ± 2.5%, respectively (P < 0.001).
CONCLUSIONS
Intracoronary transplantation of WJ-MSCs 3-7 days after AMI in selected patients significantly improves LVEF, with the infusion of a booster dose 10 days later augmenting this effect.
TRIAL REGISTRATION
Trial registration: Iranian Registry of Clinical Trials, IRCT20201116049408N1. Retrospectively Registered 20 Nov. 2020, https://en.irct.ir/trial/52357.
Identifiants
pubmed: 37740221
doi: 10.1186/s13287-023-03495-1
pii: 10.1186/s13287-023-03495-1
pmc: PMC10517503
doi:
Banques de données
IRCT
['IRCT20201116049408N1']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
264Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
PLoS One. 2015 Oct 19;10(10):e0139870
pubmed: 26479722
Stem Cells. 2009 Jan;27(1):230-7
pubmed: 18772313
Nature. 2001 Apr 5;410(6829):701-5
pubmed: 11287958
Circulation. 2012 Jan 3;125(1):e2-e220
pubmed: 22179539
Eur Heart J. 2016 Jan 14;37(3):256-63
pubmed: 26405233
Int J Stem Cells. 2018 May 30;11(1):1-12
pubmed: 29482311
Circulation. 2002 Dec 10;106(24):3009-17
pubmed: 12473544
Stem Cell Res Ther. 2022 Aug 12;13(1):409
pubmed: 35962420
Clin Cardiol. 2009 Aug;32(8):458-66
pubmed: 19685520
Circ Heart Fail. 2010 May;3(3):e5-6
pubmed: 20484192
Circ Res. 2013 Aug 30;113(6):810-34
pubmed: 23989721
Front Cardiovasc Med. 2022 Aug 09;9:961920
pubmed: 36017096
BMC Cardiovasc Disord. 2022 Jun 9;22(1):259
pubmed: 35681123
Am J Med. 2002 Sep;113(4):324-30
pubmed: 12361819
Stem Cell Res Ther. 2021 Dec 7;12(1):600
pubmed: 34876213
Eur Heart J. 2014 Apr;35(15):989-98
pubmed: 24026778
BMC Med. 2015 Jul 10;13:162
pubmed: 26162993
Stem Cell Res Ther. 2022 May 16;13(1):203
pubmed: 35578329
J Am Coll Cardiol. 2003 Oct 15;42(8):1446-53
pubmed: 14563590
Circ Res. 2018 Jul 6;123(2):132-137
pubmed: 29976683
Cardiovasc Drugs Ther. 2022 Jul 25;:
pubmed: 35876933
Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):326-33
pubmed: 22357361
Circulation. 2008 Nov 11;118(20):2057-62
pubmed: 18955667
Cochrane Database Syst Rev. 2015 Sep 30;(9):CD006536
pubmed: 26419913
Nat Med. 2001 Apr;7(4):430-6
pubmed: 11283669
Circulation. 2016 Sep 27;134(13):e282-93
pubmed: 27208050
Circ Res. 2015 Jan 2;116(1):12-5
pubmed: 25552688
Eur J Heart Fail. 2009 Jul;11(7):691-8
pubmed: 19420003
Lancet. 2001 Jan 27;357(9252):279-80
pubmed: 11214133
PLoS One. 2014 May 07;9(5):e96725
pubmed: 24806457
Nat Med. 1998 Aug;4(8):929-33
pubmed: 9701245
J Am Coll Cardiol. 2012 Jan 31;59(5):539-40
pubmed: 22281257
JAMA. 2012 Dec 12;308(22):2369-79
pubmed: 23117550
Circulation. 1996 Nov 1;94(9 Suppl):II332-6
pubmed: 8901770
JAMA. 2014 Jan 1;311(1):62-73
pubmed: 24247587
JAMA. 2012 Dec 12;308(22):2380-9
pubmed: 23129008
Cytotherapy. 2021 Nov;23(11):974-979
pubmed: 34112613
JAMA. 2011 Nov 16;306(19):2110-9
pubmed: 22084195
Circ Res. 2011 Sep 30;109(8):923-40
pubmed: 21960725
Trials. 2022 Apr 12;23(1):293
pubmed: 35413932