Acute myocardial infarction reparation/regeneration strategy using Wharton's jelly multipotent stem cells as an 'unlimited' therapeutic agent: 3-year outcomes in a pilot cohort of the CIRCULATE-AMI trial.

LV ejection fraction Wharton’s jelly multipotent stem cells efficacy infarct size myocardial regeneration safety

Journal

Postepy w kardiologii interwencyjnej = Advances in interventional cardiology
ISSN: 1734-9338
Titre abrégé: Postepy Kardiol Interwencyjnej
Pays: Poland
ID NLM: 101272671

Informations de publication

Date de publication:
Dec 2022
Historique:
received: 01 11 2021
accepted: 02 03 2022
entrez: 27 3 2023
pubmed: 28 3 2023
medline: 28 3 2023
Statut: ppublish

Résumé

CIRCULATE-AMI (NCT03404063), a cardiac magnetic resonance imaging (cMRI) infarct size-reduction-powered double-blind randomized controlled trial (RCT) of standardized Wharton jelly multipotent stem cells (WJMSCs, CardioCell Investigational Medical Product) vs. placebo (2 : 1) transcoronary transfer on acute myocardial infarction (AMI) day ~5-7, is preceded by safety and feasibility evaluation in a pilot study cohort (CIRCULATE-AMI PSC). To evaluate WJMSC transplantation safety and evolution of left ventricular (LV) remodeling in CIRCULATE-AMI PSC. In 10 consecutive patients (32-65 years, peak CK-MB 533 ±89 U/l, cMRI-LVEF 40.3 ±2.7%, cMRI-infarct size 20.1 ±2.8%), 30 × 10 WJMSC transfer was safe and occurred in the absence of coronary (TIMI-3 in all) or myocardial (corrected TIMI frame count (cTFC) 45 ±8 vs. 44 ±9, CIRCULATE-AMI PSC data suggest that WJMSC transcoronary application ~5-7 days after large AMI in humans is feasible and safe and it may be associated with a durable LVEF improvement. CIRCULATE-AMI RCT will quantify the magnitude of LV adverse remodeling attenuation with CardioCell/placebo administration.

Identifiants

pubmed: 36967843
doi: 10.5114/aic.2022.121125
pii: 48158
pmc: PMC10031665
doi:

Types de publication

Journal Article

Langues

eng

Pagination

476-482

Informations de copyright

Copyright: © 2022 Termedia Sp. z o. o.

Déclaration de conflit d'intérêts

The authors declare no conflict of interest.

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Auteurs

Ewa Kwiecien (E)

Department of Cardiac and Vascular Diseases, Jagiellonian University, Krakow, Poland.
Clinical Department, John Paul II Hospital, Krakow, Poland.

Leszek Drabik (L)

Department of Cardiac and Vascular Diseases, Jagiellonian University, Krakow, Poland.
Clinical Department, John Paul II Hospital, Krakow, Poland.

Adam Mazurek (A)

Department of Cardiac and Vascular Diseases, Jagiellonian University, Krakow, Poland.
Clinical Department, John Paul II Hospital, Krakow, Poland.

Danuta Jarocha (D)

Department of Transplantation, John Paul II Hospital, Krakow, Poland.
Division of Hematology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Malgorzata Urbanczyk (M)

Magnetic Resonance Imaging Laboratory, Krakow, Poland.

Wojciech Szot (W)

Nuclear Imaging Laboratory, Krakow, Poland.

Robert P Banys (RP)

Magnetic Resonance Imaging Laboratory, Krakow, Poland.

Anna Kozynacka-Fras (A)

Clinical Department, John Paul II Hospital, Krakow, Poland.

Wojciech Plazak (W)

Department of Cardiac and Vascular Diseases, Jagiellonian University, Krakow, Poland.
Clinical Department, John Paul II Hospital, Krakow, Poland.

Maria Olszowska (M)

Department of Cardiac and Vascular Diseases, Jagiellonian University, Krakow, Poland.
Clinical Department, John Paul II Hospital, Krakow, Poland.

Dorota Sobczyk (D)

Clinical Department, John Paul II Hospital, Krakow, Poland.

Magdalena Kostkiewicz (M)

Clinical Department, John Paul II Hospital, Krakow, Poland.
Nuclear Imaging Laboratory, Krakow, Poland.

Marcin Majka (M)

Department of Transplantation, John Paul II Hospital, Krakow, Poland.

Piotr Podolec (P)

Department of Cardiac and Vascular Diseases, Jagiellonian University, Krakow, Poland.
Clinical Department, John Paul II Hospital, Krakow, Poland.

Piotr Musialek (P)

Department of Cardiac and Vascular Diseases, Jagiellonian University, Krakow, Poland.
Clinical Department, John Paul II Hospital, Krakow, Poland.

Classifications MeSH