Myocardial regeneration strategy using Wharton's jelly mesenchymal stem cells as an off-the-shelf "unlimited" therapeutic agent : results from the Acute Myocardial Infarction First-in-Man Study

2015
journal article
article
70
cris.lastimport.wos2024-04-09T21:00:03Z
dc.abstract.enIntroduction: In large-animal acute myocardial infarction (AMI) models, Wharton’s jelly (umbilical cord matrix) mesenchymal stem cells (WJMSCs) effectively promote angiogenesis and drive functional myocardial regeneration. Human data are lacking. Aim: To evaluate the feasibility and safety of a novel myocardial regeneration strategy using human WJMSCs as a unique, allogenic but immuno-privileged, off-the-shelf cellular therapeutic agent. Material and methods: The inclusion criterion was first, large (LVEF ≤ 45%, CK-MB > 100 U/l) AMI with successful infarct-related artery primary percutaneous coronary intervention reperfusion (TIMI ≥ 2). Ten consecutive patients (age 32–65 years, peak hs-troponin T 17.3 ±9.1 ng/ml and peak CK-MB 533 ±89 U/l, sustained echo LVEF reduction to 37.6 ±2.6%, cMRI LVEF 40.3 ±2.7% and infarct size 20.1 ±2.8%) were enrolled. Results: 30 × 106 WJMSCs were administered (LAD/Cx/RCA in 6/3/1) per protocol at ≈ 5–7 days using a cell delivery dedicated, coronary-non-occlusive method. No clinical symptoms or ECG signs of myocardial ischemia occurred. There was no epicardial flow or myocardial perfusion impairment (TIMI-3 in all; cTFC 45 ±8 vs. 44 ±9, p = 0.51), and no patient showed hs-troponin T elevation (0.92 ±0.29 ≤ 24 h before vs. 0.89 ±0.28 ≤ 24 h after; decrease, p = 0.04). One subject experienced, 2 days after cell transfer, a transient temperature rise (38.9°C); this was reactive to paracetamol with no sequel. No other adverse events and no significant arrhythmias (ECG Holter) occurred. Up to 12 months there was one new, non-index territory lethal AMI but no adverse events that might be attributable to WJMSC treatment. Conclusions: This study demonstrated the feasibility and procedural safety of WJMSC use as off-the-shelf cellular therapy in human AMI and suggested further clinical safety of WJMSC cardiac transfer, providing a basis for randomized placebo-controlled endpoint-powered evaluation.pl
dc.affiliationWydział Lekarski : Instytut Kardiologiipl
dc.affiliationWydział Lekarski : Instytut Pediatriipl
dc.cm.date2020-01-07
dc.cm.id73044
dc.contributor.authorMusiałek, Piotr - 173944 pl
dc.contributor.authorMazurek, Adampl
dc.contributor.authorJarocha, Danuta - 200519 pl
dc.contributor.authorTekieli, Łukaszpl
dc.contributor.authorSzot, Wojciech - 133597 pl
dc.contributor.authorKostkiewicz, Magdalena - 130307 pl
dc.contributor.authorBanyś, Robert Pawełpl
dc.contributor.authorUrbanczyk, Malgorzatapl
dc.contributor.authorKądzielski, Andrzejpl
dc.contributor.authorTrystuła, Mariusz - 356558 pl
dc.contributor.authorKijowski, Jacek - 130099 pl
dc.contributor.authorŻmudka, Krzysztof - 133948 pl
dc.contributor.authorPodolec, Piotr - 133185 pl
dc.contributor.authorMajka, Marcin - 130808 pl
dc.date.accessioned2020-01-17T08:49:41Z
dc.date.available2020-01-17T08:49:41Z
dc.date.issued2015pl
dc.date.openaccess0
dc.description.accesstimew momencie opublikowania
dc.description.number2 (40)pl
dc.description.physical100-107pl
dc.description.points15pl
dc.description.versionostateczna wersja wydawcy
dc.description.volume11pl
dc.identifier.doi10.5114/pwki.2015.52282pl
dc.identifier.eissn1897-4295pl
dc.identifier.issn1734-9338pl
dc.identifier.projectROD UJ / OPpl
dc.identifier.urihttps://ruj.uj.edu.pl/xmlui/handle/item/135755
dc.languageengpl
dc.language.containerengpl
dc.rightsUdzielam licencji. Uznanie autorstwa - Użycie niekomercyjne - Na tych samych warunkach 4.0 Międzynarodowa*
dc.rights.licenceCC-BY-NC-SA
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/4.0/legalcode.pl*
dc.share.typeotwarte czasopismo
dc.subject.enmyocardial regenerationpl
dc.subject.enWharton’s jelly mesenchymal stem cellspl
dc.subject.enhuman umbilical cord matrixpl
dc.subject.enacute myocardial infarctionpl
dc.subject.enfirst-in-manpl
dc.subject.ensafetypl
dc.subject.enfeasibilitypl
dc.subtypeArticlepl
dc.titleMyocardial regeneration strategy using Wharton's jelly mesenchymal stem cells as an off-the-shelf "unlimited" therapeutic agent : results from the Acute Myocardial Infarction First-in-Man Studypl
dc.title.journalPostępy w Kardiologii Interwencyjnejpl
dc.typeJournalArticlepl
dspace.entity.typePublication
cris.lastimport.wos
2024-04-09T21:00:03Z
dc.abstract.enpl
Introduction: In large-animal acute myocardial infarction (AMI) models, Wharton’s jelly (umbilical cord matrix) mesenchymal stem cells (WJMSCs) effectively promote angiogenesis and drive functional myocardial regeneration. Human data are lacking. Aim: To evaluate the feasibility and safety of a novel myocardial regeneration strategy using human WJMSCs as a unique, allogenic but immuno-privileged, off-the-shelf cellular therapeutic agent. Material and methods: The inclusion criterion was first, large (LVEF ≤ 45%, CK-MB > 100 U/l) AMI with successful infarct-related artery primary percutaneous coronary intervention reperfusion (TIMI ≥ 2). Ten consecutive patients (age 32–65 years, peak hs-troponin T 17.3 ±9.1 ng/ml and peak CK-MB 533 ±89 U/l, sustained echo LVEF reduction to 37.6 ±2.6%, cMRI LVEF 40.3 ±2.7% and infarct size 20.1 ±2.8%) were enrolled. Results: 30 × 106 WJMSCs were administered (LAD/Cx/RCA in 6/3/1) per protocol at ≈ 5–7 days using a cell delivery dedicated, coronary-non-occlusive method. No clinical symptoms or ECG signs of myocardial ischemia occurred. There was no epicardial flow or myocardial perfusion impairment (TIMI-3 in all; cTFC 45 ±8 vs. 44 ±9, p = 0.51), and no patient showed hs-troponin T elevation (0.92 ±0.29 ≤ 24 h before vs. 0.89 ±0.28 ≤ 24 h after; decrease, p = 0.04). One subject experienced, 2 days after cell transfer, a transient temperature rise (38.9°C); this was reactive to paracetamol with no sequel. No other adverse events and no significant arrhythmias (ECG Holter) occurred. Up to 12 months there was one new, non-index territory lethal AMI but no adverse events that might be attributable to WJMSC treatment. Conclusions: This study demonstrated the feasibility and procedural safety of WJMSC use as off-the-shelf cellular therapy in human AMI and suggested further clinical safety of WJMSC cardiac transfer, providing a basis for randomized placebo-controlled endpoint-powered evaluation.
dc.affiliationpl
Wydział Lekarski : Instytut Kardiologii
dc.affiliationpl
Wydział Lekarski : Instytut Pediatrii
dc.cm.date
2020-01-07
dc.cm.id
73044
dc.contributor.authorpl
Musiałek, Piotr - 173944
dc.contributor.authorpl
Mazurek, Adam
dc.contributor.authorpl
Jarocha, Danuta - 200519
dc.contributor.authorpl
Tekieli, Łukasz
dc.contributor.authorpl
Szot, Wojciech - 133597
dc.contributor.authorpl
Kostkiewicz, Magdalena - 130307
dc.contributor.authorpl
Banyś, Robert Paweł
dc.contributor.authorpl
Urbanczyk, Malgorzata
dc.contributor.authorpl
Kądzielski, Andrzej
dc.contributor.authorpl
Trystuła, Mariusz - 356558
dc.contributor.authorpl
Kijowski, Jacek - 130099
dc.contributor.authorpl
Żmudka, Krzysztof - 133948
dc.contributor.authorpl
Podolec, Piotr - 133185
dc.contributor.authorpl
Majka, Marcin - 130808
dc.date.accessioned
2020-01-17T08:49:41Z
dc.date.available
2020-01-17T08:49:41Z
dc.date.issuedpl
2015
dc.date.openaccess
0
dc.description.accesstime
w momencie opublikowania
dc.description.numberpl
2 (40)
dc.description.physicalpl
100-107
dc.description.pointspl
15
dc.description.version
ostateczna wersja wydawcy
dc.description.volumepl
11
dc.identifier.doipl
10.5114/pwki.2015.52282
dc.identifier.eissnpl
1897-4295
dc.identifier.issnpl
1734-9338
dc.identifier.projectpl
ROD UJ / OP
dc.identifier.uri
https://ruj.uj.edu.pl/xmlui/handle/item/135755
dc.languagepl
eng
dc.language.containerpl
eng
dc.rights*
Udzielam licencji. Uznanie autorstwa - Użycie niekomercyjne - Na tych samych warunkach 4.0 Międzynarodowa
dc.rights.licence
CC-BY-NC-SA
dc.rights.uri*
http://creativecommons.org/licenses/by-nc-sa/4.0/legalcode.pl
dc.share.type
otwarte czasopismo
dc.subject.enpl
myocardial regeneration
dc.subject.enpl
Wharton’s jelly mesenchymal stem cells
dc.subject.enpl
human umbilical cord matrix
dc.subject.enpl
acute myocardial infarction
dc.subject.enpl
first-in-man
dc.subject.enpl
safety
dc.subject.enpl
feasibility
dc.subtypepl
Article
dc.titlepl
Myocardial regeneration strategy using Wharton's jelly mesenchymal stem cells as an off-the-shelf "unlimited" therapeutic agent : results from the Acute Myocardial Infarction First-in-Man Study
dc.title.journalpl
Postępy w Kardiologii Interwencyjnej
dc.typepl
JournalArticle
dspace.entity.type
Publication
Affiliations

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