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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
myocardial regeneration
Wharton’s jelly mesenchymal stem cells
human umbilical cord matrix
acute myocardial infarction
first-in-man
safety
feasibility
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.
cris.lastimport.wos | 2024-04-09T21:00:03Z | |
dc.abstract.en | 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. | pl |
dc.affiliation | Wydział Lekarski : Instytut Kardiologii | pl |
dc.affiliation | Wydział Lekarski : Instytut Pediatrii | pl |
dc.cm.date | 2020-01-07 | |
dc.cm.id | 73044 | |
dc.contributor.author | Musiałek, Piotr - 173944 | pl |
dc.contributor.author | Mazurek, Adam | pl |
dc.contributor.author | Jarocha, Danuta - 200519 | pl |
dc.contributor.author | Tekieli, Łukasz | pl |
dc.contributor.author | Szot, Wojciech - 133597 | pl |
dc.contributor.author | Kostkiewicz, Magdalena - 130307 | pl |
dc.contributor.author | Banyś, Robert Paweł | pl |
dc.contributor.author | Urbanczyk, Malgorzata | pl |
dc.contributor.author | Kądzielski, Andrzej | pl |
dc.contributor.author | Trystuła, Mariusz - 356558 | pl |
dc.contributor.author | Kijowski, Jacek - 130099 | pl |
dc.contributor.author | Żmudka, Krzysztof - 133948 | pl |
dc.contributor.author | Podolec, Piotr - 133185 | pl |
dc.contributor.author | Majka, Marcin - 130808 | pl |
dc.date.accessioned | 2020-01-17T08:49:41Z | |
dc.date.available | 2020-01-17T08:49:41Z | |
dc.date.issued | 2015 | pl |
dc.date.openaccess | 0 | |
dc.description.accesstime | w momencie opublikowania | |
dc.description.number | 2 (40) | pl |
dc.description.physical | 100-107 | pl |
dc.description.points | 15 | pl |
dc.description.version | ostateczna wersja wydawcy | |
dc.description.volume | 11 | pl |
dc.identifier.doi | 10.5114/pwki.2015.52282 | pl |
dc.identifier.eissn | 1897-4295 | pl |
dc.identifier.issn | 1734-9338 | pl |
dc.identifier.project | ROD UJ / OP | pl |
dc.identifier.uri | https://ruj.uj.edu.pl/xmlui/handle/item/135755 | |
dc.language | eng | pl |
dc.language.container | eng | pl |
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.en | myocardial regeneration | pl |
dc.subject.en | Wharton’s jelly mesenchymal stem cells | pl |
dc.subject.en | human umbilical cord matrix | pl |
dc.subject.en | acute myocardial infarction | pl |
dc.subject.en | first-in-man | pl |
dc.subject.en | safety | pl |
dc.subject.en | feasibility | pl |
dc.subtype | Article | pl |
dc.title | 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 | pl |
dc.title.journal | Postępy w Kardiologii Interwencyjnej | pl |
dc.type | JournalArticle | pl |
dspace.entity.type | Publication |
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