<br>Original paper<br>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

Piotr Musialek; Adam Mazurek; Danuta Jarocha; Lukasz Tekieli; Wojciech Szot; Magdalena Kostkiewicz; R. Pawel Banys; Malgorzata Urbanczyk; Andrzej Kadzielski; Mariusz Trystula; Jacek Kijowski; Krzysztof Zmudka; Piotr Podolec; Marcin Majka

doi:10.5114/pwki.2015.52282

eISSN: 1897-4295
ISSN: 1734-9338

Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej

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Original paper
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

Piotr Musialek

,

Adam Mazurek

,

Danuta Jarocha

,

Lukasz Tekieli

,

Wojciech Szot

,

Magdalena Kostkiewicz

,

R. Pawel Banys

,

Malgorzata Urbanczyk

,

Andrzej Kadzielski

,

Mariusz Trystula

,

Jacek Kijowski

,

Krzysztof Zmudka

,

Piotr Podolec

,

Marcin Majka

Postep Kardiol Inter 2015; 11, 2 (40): 100–107

DOI: https://doi.org/10.5114/pwki.2015.52282

Online publish date: 2015/06/22

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AMA

Musialek P, Mazurek A, Jarocha D, et al. Original paperMyocardial 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. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2015;11(2):100-107. doi:10.5114/pwki.2015.52282.

APA

Musialek, P., Mazurek, A., Jarocha, D., Tekieli, L., Szot, W.,  & Kostkiewicz, M. et al. (2015). Original paperMyocardial 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. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 11(2), 100-107. https://doi.org/10.5114/pwki.2015.52282

Chicago

Musialek, Piotr, Adam Mazurek, Danuta Jarocha, Lukasz Tekieli, Wojciech Szot, Magdalena Kostkiewicz,  and R. Pawel Banys et al. 2015. "Original paperMyocardial 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". Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej 11 (2): 100-107. doi:10.5114/pwki.2015.52282.

Harvard

Musialek, P., Mazurek, A., Jarocha, D., Tekieli, L., Szot, W., Kostkiewicz, M., Banys, R., Urbanczyk, M., Kadzielski, A., Trystula, M., Kijowski, J., Zmudka, K., Podolec, P.,  and Majka, M. (2015). Original paperMyocardial 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. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 11(2), pp.100-107. https://doi.org/10.5114/pwki.2015.52282

MLA

Musialek, Piotr et al. "Original paperMyocardial 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." Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, vol. 11, no. 2, 2015, pp. 100-107. doi:10.5114/pwki.2015.52282.

Vancouver

Musialek P, Mazurek A, Jarocha D, Tekieli L, Szot W, Kostkiewicz M et al. Original paperMyocardial 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. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2015;11(2):100-107. doi:10.5114/pwki.2015.52282.

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.

keywords:

myocardial regeneration, Wharton’s jelly mesenchymal stem cells, human umbilical cord matrix, acute myocardial infarction, first-in-man, safety, feasibility

Original paperMyocardial 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

Piotr Musialek , Adam Mazurek , Danuta Jarocha , Lukasz Tekieli , Wojciech Szot , Magdalena Kostkiewicz , R. Pawel Banys , Malgorzata Urbanczyk , Andrzej Kadzielski , Mariusz Trystula , Jacek Kijowski , Krzysztof Zmudka , Piotr Podolec , Marcin Majka

myocardial regeneration, Wharton’s jelly mesenchymal stem cells, human umbilical cord matrix, acute myocardial infarction, first-in-man, safety, feasibility

Original paper
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

Piotr Musialek

,

Adam Mazurek

,

Danuta Jarocha

,

Lukasz Tekieli

,

Wojciech Szot

,

Magdalena Kostkiewicz

,

R. Pawel Banys

,

Malgorzata Urbanczyk

,

Andrzej Kadzielski

,

Mariusz Trystula

,

Jacek Kijowski

,

Krzysztof Zmudka

,

Piotr Podolec

,

Marcin Majka