Ayala, Verónica Crisostomo

Climent, Andreu M.

Diaz, Claudia Baez

Fdez-Aviles, Francisco

Sanchez Margallo, Francisco Miguel

Sancho, Susana Suarez

Sanz-Ruiz, Ricardo

Elsevier - Publisher Connector 

Segment Variable SC Placebo p value
Culprit stented segment D MLA (mm2) -1.2 [-3.0, -0.2] -1.5 [-3.2, -0.1] 0.97
% NIH volume (%) 12.1 [3.7, 29.8] 7.6 [3.5, 30.6] 0.95
D Maximum arc of attenuated plaque ( ) 1.0 [-3.6, 9.0] -12.4 [-25.0, -3.7] 0.004
Culprit proximal 5mm
reference segment
D MLA (mm2) -1.2 [-2.7, -0.7] -0.7 [-1.2, -0.5] 0.19
D% plaque volume (%) 3.3 [0.6, 8.3] 3.1 [-2.7, 7.0] 0.41
Culprit distal 5mm
reference segment
D MLA (mm2) 0.0 [-1.5, 0.2] -0.1 [-0.2, 0.4] 0.72
D% plaque volume (%) 3.9 [0.3, 8.3] 0.6 [-2.1, 5.2] 0.19
Proximal non-culprit
segment in culprit vessel
D MLA (mm2) -0.4 [-0.8, -0.1] -0.6 [-1.2, 0.5] 0.69
D% plaque volume (%) 0.8 [-1.9, 2.7] -0.5 [-3.5, 2.9] 0.53
Distal non-culprit segment
in culprit vessel
D MLA (mm2) -0.2 [-0.7, 0.4] -0.1 [-0.7, 0.6] 0.97
D% plaque volume (%) -1.1 [-2.7, 0.0] -0.8 [-2.5, 2.4] 0.50
Non-culprit segment in
non-culprit vessel
D MLA (mm2) -0.2 [-0.7, 0.1] 0.2 [-0.1, 0.6] 0.10
D% plaque volume (%) 0.6 [-1.9, 2.1] -1.4 [-2.0, 1.3] 0.50
SATURDAY, SEPTEMBER 13, 2014, 5:00 PM–7:00 PM www.jacctctabstracts2014.comTCT-152
ALLogeneic Heart STem Cells To Achieve Myocardial Regeneration
(ALLSTAR): The Six Month Phase I Safety Results
Raj Makkar1, Richard Schatz2, Jay H. Traverse3, Andrew Hamer4, Katherine Beattie4,
Rachel R. Smith4, Frances Kivel4, Linda Marban4, Eduardo Marban1,
Timothy D. Henry1
1Cedars-Sinai Heart Institute, Los Angeles, CA, 2Scripps CLinic, La Jolla, USA,
3Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital,
Minneapolis, MN, 4Capricor, Inc., Beverly Hills, CA
Background: In CADUCEUS, autologous cardiosphere-derived cells decreased infarct
size and increased viable tissue in post-MI patients. The ﬁrst-in-human Phase I
ALLSTAR trial was designed to test the safety and feasibility of intracoronary infusion
of allogeneic cardiosphere-derived cells (CAP-1002) in patients with a previous anterior
myocardial infarction (MI), within the prior 12 months with scar size >15% by MRI.
Methods: A total of 14 adult subjects (mean age ¼ 55.6 yr; range 40-66 years) with a
recent (28 – 90 days; n¼9) or chronic (91-365 days; n¼5) anterior wall MI (mean infarct
size 25.4%; range 15.3% – 32.7%) and LV dysfunction (mean LVEF 42%; range 26.7%
- 55.1%) were prospectively enrolled and infused with CAP-1002 (n¼4 at 12.5M dose;
n¼10 at 25Mdose) via stop-ﬂow intracoronary infusion. Primary safety endpoints were:
MACE events (recurrent MI, hospitalization or ER treatment for heart failure, LVAD
placement or heart transplantation), acute myocarditis, death due to arrhythmias or
unwitnessed death in persons otherwise well. Humoral and cellular immunologic re-
sponses were assessed via single antigen bead and ELISpot assays.
Results: No pre-speciﬁed safety endpoint occurred. Only two adverse events were
treatment-related, both transient hypotension related to nitroglycerin. There were no
clinically signiﬁcant rises in peri-procedural cardiac enzymes. Donor speciﬁc anti-
bodies (DSAs) were present in four subjects prior to infusion; one resolved and three
persisted during 6 months of follow up. De novo DSA’s developed in four subjects,
three resolved during follow up and one persisted at 6 months of follow up. All DSA
levels observed were low (MFI< 5000). ELISpot revealed no de novo cellular
immune responses.
Conclusions: Intracoronary infusion of allogeneic cardiosphere-derived cells (CAP-
1002) appears to be safe and feasible. On the basis of the present ﬁndings, the
ALLSTAR trial has proceeded to a Phase II randomized, double-blind component,
powered to assess reduction of scar size by MRI.
TCT-153
Safety and efﬁcacy of transendocardial injection of mesenchymal and induced
pluripotent stem cells in a swine subacute model of myocardial ischemia
Ricardo Sanz-Ruiz1, Verónica Crisostomo Ayala2, Claudia Baez Diaz2,
Susana Suarez Sancho1, Andreu M. Climent1, Francisco Miguel Sanchez Margallo2,
Francisco Fdez-Aviles3
1Hospital General Universitario Gregorio Marañón, Madrid, Spain, 2Centro de
Cirugía de Mínima Invasión Jesús Usón, Cáceres, Spain, 3Hospital General
Universitario Gregorio Marañon, Madrid, Spain
Background: Mesenchymal stem cells (MSC) are the most promising cells for
ischemic myocardial repair. Nowadays we can obtain them from induced pluripotent
stem cells (iPS). Our objective is to compare the safety and efﬁcacy of “conventional”
MSC and iPS-derived MSC in a large animal model of myocardial ischemia.
Methods: Phase I/II preclinical randomized, placebo-controlled trial, with 30 large
white pigs included. Acute myocardial infarction (AMI) will be created after 90-min
occlusion of the LAD. The 3 groups are: injection of 20x106 MSC from human ad-
ipose tissue (n¼10); injection of 20x106 MSC from human iPS (n¼10); injection of
saline (n¼10). Injections will be performed in the scar border with the NOGA XP
platform, 7 days after AMI. Safety endpoints include MACE, malignant arrhythmias
and lab parameters (intraprocedural and for 5 weeks). Efﬁcacy endpoints include scar
size and LV parameters (MRI) and myocardial repair by histology (ﬁbrosis and
capillary density, staining with human nuclear antibodies) at 5 weeks.Results: So far 10 pigs have been included, weight 34.86.2 kg. Troponin and CPK
values (mg/L) were preinjection 0.41 0.61 and 4.73.0, and postinjection 0.440.33
and 8.65.1, respectively. Cell injection was successful in all cases, with 1 episode of
ventricular ﬁbrillation successfully cardioverted and no other events during the
procedures or in the follow-up.B46 JACC Vol 64/11/Suppl B j SeConclusions: This is the ﬁrst stem cell study designed to assess the cardiac repair
ability of iPS-derived MSC. NOGA-guided injections 7 days after AMI were safe. No
efﬁcacy data are available, but will be during the conference.
TCT-154
Impact of Intracoronary Injection of CD133+ Bone Marrow Stem Cells on
Coronary Atherosclerotic Progression in Patients with STEMI:
A COMPARE-AMI IVUS Substudy
Fuyu Qiu1, Akiko Maehara2, Ramez El Khoury3, Philippe Genereux4, Laura LaSalle5,
Gary S. Mintz6, Nicolas Noiseux7, François Gobeil7, Louis-Mathieu Stevens7,
Francois Reeves8, Alain Rivard9, Samer Mansour10
1Cardiovascular Research Foundation and Columbia University Medical Center,
New York, NY, 2Cardiovascular Reserach Foundation and Columbia University
Medical Center, New York, United States, 3Centre Hospitalier de l’Université de
Montréal, Montreal, Quebec, 4Columbia University Medical Center, New York,
United States, 5Cardiovascular Research Foundation, New-York, NY,
6Cardiovascular Research Foundation, Washington, United States, 7University of
Montreal, Montreal, Quebec, 8CHUM, Montreal, Quebec, 9CHUM, Montreal,
Québec, 10Centre Hospitalier de l’Universite de Montreal, Montreal, Canada
Background: COMPARE-AMI was a randomized, prospective, double-blind, single-
center trial to investigate the effect of an intracoronary injection of CD133+ bone
marrow stem cells (SC) vs placebo (Placebo) on infarcted myocardium in pts with ST-
segment elevation myocardial infarction (STEMI) who underwent primary percuta-
neous coronary intervention. This IVUS substudy sought to evaluate the adverse effect
of CD133+ bone marrow stem cells onto the progression of coronary artery disease in
the stented, non-stented segment of culprit vessel, and non-culprit vessels.
Methods: Baseline and 4-month follow-up IVUS images were obtained in 17 SC and
20 Placebo pts. In culprit vessels stented and 5mm proximal and distal reference
segments, and proximal and distal non-stented segments were analyzed every 1mm; in
non-culprit vessels the entire segments were analyzed every 1mm.
Results: In the culprit vessel analysis, in-stent median % neointimal hyperplasia (NIH)
(¼NIH/stent volume) (12.1%vs 7.6%, p¼0.95), reduction ofminimal lumen area (MLA)
(-1.2 mm2 vs -1.5 mm2, p¼0.97), andMLA at follow-up (4.3mm2 vs 5.3mm2, p¼0.22)
were similar between SC and Placebo. Changes in proximal and distal non-stented
segment lumen areas and %plaque volume (¼plaque/vessel volume) were also similar
between SC and Placebo pts. However, there was a decrease in the maximum arc of
attenuated plaque behind the stent frombaseline to follow-up in Placebo, but not in SC pts
(-12.4 vs. 1.0, p¼0.004). In the non-culprit vessel analysis, there were no differences in
changes of MLA, %plaque volume, or attenuated plaque between SC and Placebo pts.
Conclusions: CD133+ bone marrow stem cells (SC) injection through the coronary
artery has no effect on disease progression in both culprit and non-culprit vessels.TCT-155
A Novel Multi Lumen Compliant Balloon Catheter (ND Infusion Catheter)
Preserves Stem Cell Viability and Improves Dispersion When Compared to a
Standard Single Lumen Balloon Angioplasty Catheter
Nabil Dib1, John P. Abraham2, Brian D. Plourde2, Dillon Schwalbach2,
DeAnn Dana3, Lester Myers4, Katherine Hunkler4, Siddharth R D’Silva3,
Todd R. Flower5, Robert E. Kohler3
1Mercy Gilbert Medical Centers/Dignity Health, Gilbert, United States, 2University of
St Thomas, St Paul, MN, 3Translational Research Institute, Gilbert, AZ, 4Celebration
Stem Cell Centre, Gilbert, AZ, 5Celebration Stem Cell Center, Gilbert, AZ
Background: Intracoronary infusion of stem cells (SC) is typically administered
through a single lumen balloon angioplasty catheter (SLC). These catheters are not
optimized for SC delivery and potentially compromise SC viability and effectiveness.
A multi-lumen catheter (MLC), (ND Infusion Catheter, Translational Research
Institute Gilbert, AZ) may preserve cell viability (CV) and improve dispersion.
Methods: A standard .014” over the wire SLC was compared to a novel MLC 3 Fr.
014” rapid exchange catheter with 6 micro-lumens that act as cell separators.ptember 13–17, 2014 j TCT Abstracts/Cell Therapy and Angiogenesis


TCT-153 Safety and efficacy of transendocardial injection of mesenchymal and induced pluripotent stem cells in a swine subacute model of myocardial ischemia 

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TCT-153 Safety and efficacy of transendocardial injection of mesenchymal and induced pluripotent stem cells in a swine subacute model of myocardial ischemia

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