eISSN: 1897-4295
ISSN: 1734-9338
Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej
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4/2022
vol. 18
 
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abstract:
Original paper

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

Ewa Kwiecien
1, 2
,
Leszek Drabik
1, 2
,
Adam Mazurek
1, 2
,
Danuta Jarocha
3, 4
,
Malgorzata Urbanczyk
5
,
Wojciech Szot
6
,
Robert P. Banys
5
,
Anna Kozynacka-Fras
2
,
Wojciech Plazak
1, 2
,
Maria Olszowska
1, 2
,
Dorota Sobczyk
2
,
Magdalena Kostkiewicz
2, 6
,
Marcin Majka
3
,
Piotr Podolec
1, 2
,
Piotr Musialek
1, 2

1.
Department of Cardiac and Vascular Diseases, Jagiellonian University, Krakow, Poland
2.
Clinical Department, John Paul II Hospital, Krakow, Poland
3.
Department of Transplantation, Krakow, Poland, John Paul II Hospital, Krakow, Poland
4.
Division of Hematology, The Children’s Hospital of Philadelphia, Philadelphia, PA, USA
5.
Magnetic Resonance Imaging Laboratory, Krakow, Poland
6.
Nuclear Imaging Laboratory, Krakow, Poland
Adv Interv Cardiol 2022; 18, 4 (70): 476–482
DOI: https://doi.org/10.5114/aic.2022.121125
Online publish date: 2022/11/15
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Introduction:
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). Aim: To evaluate WJMSC transplantation safety and evolution of left ventricular (LV) remodeling in CIRCULATE-AMI PSC.

Material and methods:
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 × 106 WJMSCs were administered using a novel cell delivery-dedicated, coronary-non-occlusive method (CIRCULATE catheter). Other treatment was guideline-based.

Results:
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, p = 0.51) flow deterioration or troponin elevation. By 3 years, one patient died from a new, non-index territory AMI; there were no other major adverse cardiovascular and cerebrovascular events (MACCE) and no adverse events that might be related to WJMSCs. cMRI infarct size was reduced from 33.2 ±7.6 g to 25.5 ±6.4 g at 1 year and 23.1 ±5.6 g at 3 years (p = 0.03 vs. baseline). cMRI, SPECT, and echo showed a consistent, statistically significant increase in LVEF at 6–12 months (41.9 ±2.6% vs. 51.0 ±3.3%, 36.0 ±3.9% vs. 44.9 ±5.0%, and 38.4 ±2.5% vs. 48.0 ±2.1% respectively, p < 0.01 for all); the effect was sustained at 3 years.

Conclusions:
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.

keywords:

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