Evidence map›Paper›PMID 26161101›Full record

ArticlePostepy w kardiologii interwencyjnej = Advances in interventional cardiology2015

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 and 4 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Postepy w kardiologii interwencyjnej = Advances in interventional cardiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04703751 (Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents), which is not on this map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04703751 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents

TypeinterventionalSponsorJohn Paul II Hospital, KrakowRan2022 to 2022Enrolled10ConditionsDilated CardiomyopathyArmsTranscoronary delivery of a pharmacological agent (nitroglycerin) and cell based agent (Cardiocell) using the CIRCULATE Catheter
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.

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  13. Cellular therapies in no-option critical limb ischemia: present status and future directions.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 2 institutions in 1 country.

Piotr MusialekDepartment of Cardiac and Vascular Diseases, Jagiellonian University Medical College, Krakow, Poland ; Clinical Departments, John Paul II Hospital, Krakow, Poland.
Adam MazurekDepartment of Cardiac and Vascular Diseases, Jagiellonian University Medical College, Krakow, Poland ; Clinical Departments, John Paul II Hospital, Krakow, Poland.
Danuta JarochaDepartment of Transplantation, Jagiellonian University Medical College, Krakow, Poland.
Lukasz TekieliClinical Departments, John Paul II Hospital, Krakow, Poland ; Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Wojciech SzotNuclear Imaging Laboratory, John Paul II Hospital, Krakow, Poland.
Magdalena KostkiewiczClinical Departments, John Paul II Hospital, Krakow, Poland ; Nuclear Imaging Laboratory, John Paul II Hospital, Krakow, Poland.
R Pawel BanysMagnetic Resonance Imaging Laboratory, John Paul II Hospital, Krakow, Poland.
Malgorzata UrbanczykMagnetic Resonance Imaging Laboratory, John Paul II Hospital, Krakow, Poland.
Andrzej KadzielskiDepartment of Interventional Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Mariusz TrystulaClinical Departments, John Paul II Hospital, Krakow, Poland.
Jacek KijowskiDepartment of Transplantation, Jagiellonian University Medical College, Krakow, Poland.
Krzysztof ZmudkaClinical Departments, John Paul II Hospital, Krakow, Poland ; Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Piotr PodolecDepartment of Cardiac and Vascular Diseases, Jagiellonian University Medical College, Krakow, Poland ; Clinical Departments, John Paul II Hospital, Krakow, Poland.
Marcin MajkaDepartment of Transplantation, Jagiellonian University Medical College, Krakow, Poland.
Jagiellonian University · PLJohn Paul II Hospital · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn 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.

aimTo 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

methodsThe 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.

results30 × 10(6) 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.

conclusionsThis 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.

Indexed as

acute myocardial infarctionfeasibilityfirst-in-manhuman umbilical cord matrixmyocardial regenerationsafetyWharton's jelly mesenchymal stem cells

Identifiers

PMID26161101
PMCPMC4495125
OpenAlexW855853990

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.