Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study

We aimed to evaluate the effect of intramyocardial injections of autologous VEGF-A165-stimulated adipose-derived stromal cells (ASCs) in patients with refractory angina. MyStromalCell trial is a randomized double-blind placebo-controlled study including sixty patients with CCS/NYHA class II-III, lef...

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Main Authors: Abbas Ali Qayyum, Anders Bruun Mathiasen, Naja Dam Mygind, Jørgen Tobias Kühl, Erik Jørgensen, Steffen Helqvist, Jens Jørgen Elberg, Klaus Fuglsang Kofoed, Niels Groove Vejlstrup, Anne Fischer-Nielsen, Mandana Haack-Sørensen, Annette Ekblond, Jens Kastrup
Format: Article
Language:English
Published: Wiley 2017-01-01
Series:Stem Cells International
Online Access:http://dx.doi.org/10.1155/2017/5237063
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author Abbas Ali Qayyum
Anders Bruun Mathiasen
Naja Dam Mygind
Jørgen Tobias Kühl
Erik Jørgensen
Steffen Helqvist
Jens Jørgen Elberg
Klaus Fuglsang Kofoed
Niels Groove Vejlstrup
Anne Fischer-Nielsen
Mandana Haack-Sørensen
Annette Ekblond
Jens Kastrup
author_facet Abbas Ali Qayyum
Anders Bruun Mathiasen
Naja Dam Mygind
Jørgen Tobias Kühl
Erik Jørgensen
Steffen Helqvist
Jens Jørgen Elberg
Klaus Fuglsang Kofoed
Niels Groove Vejlstrup
Anne Fischer-Nielsen
Mandana Haack-Sørensen
Annette Ekblond
Jens Kastrup
author_sort Abbas Ali Qayyum
collection DOAJ
description We aimed to evaluate the effect of intramyocardial injections of autologous VEGF-A165-stimulated adipose-derived stromal cells (ASCs) in patients with refractory angina. MyStromalCell trial is a randomized double-blind placebo-controlled study including sixty patients with CCS/NYHA class II-III, left ventricular ejection fraction > 40%, and at least one significant coronary artery stenosis. Patients were treated with ASC or placebo in a 2 : 1 ratio. ASCs from the abdomen were culture expanded and stimulated with VEGF-A165. At 6 months follow-up, bicycle exercise tolerance increased significantly in time duration 22 s (95%CI −164 to 208 s) (P=0.034), in watt 4 (95%CI −33 to 41, 0.048), and in METs 0.2 (95%CI −1.4 to 1.8) (P=0.048) in the ASC group while there was a nonsignificant increase in the placebo group in time duration 9 s (95%CI −203 to 221 s) (P=0.053), in watt 7 (95%CI −40 to 54) (P=0.41), and in METs 0.1 (95%CI −1.7 to 1.9) (P=0.757). The difference between the groups was not significant (P=0.680, P=0.608, and P=0.720 for time duration, watt, and METs, resp.). Intramyocardial delivered VEGF-A165-stimulated ASC treatment was safe but did not improve exercise capacity compared to placebo. However, exercise capacity increased in the ASC but not in the placebo group. This trial is registered with ClinicalTrials.gov NCT01449032.
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spelling doaj-art-6bc9a440f65540048693b5d75e5a2f2e2025-02-03T01:11:18ZengWileyStem Cells International1687-966X1687-96782017-01-01201710.1155/2017/52370635237063Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled StudyAbbas Ali Qayyum0Anders Bruun Mathiasen1Naja Dam Mygind2Jørgen Tobias Kühl3Erik Jørgensen4Steffen Helqvist5Jens Jørgen Elberg6Klaus Fuglsang Kofoed7Niels Groove Vejlstrup8Anne Fischer-Nielsen9Mandana Haack-Sørensen10Annette Ekblond11Jens Kastrup12Department of Cardiology & Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Cardiology & Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Cardiology & Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Cardiology & Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Cardiology & Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Cardiology & Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Plastic Surgery, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Cardiology & Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Cardiology & Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Clinical Immunology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkCardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkCardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkDepartment of Cardiology & Cardiac Catheterization Laboratory 2014, The Heart Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, DenmarkWe aimed to evaluate the effect of intramyocardial injections of autologous VEGF-A165-stimulated adipose-derived stromal cells (ASCs) in patients with refractory angina. MyStromalCell trial is a randomized double-blind placebo-controlled study including sixty patients with CCS/NYHA class II-III, left ventricular ejection fraction > 40%, and at least one significant coronary artery stenosis. Patients were treated with ASC or placebo in a 2 : 1 ratio. ASCs from the abdomen were culture expanded and stimulated with VEGF-A165. At 6 months follow-up, bicycle exercise tolerance increased significantly in time duration 22 s (95%CI −164 to 208 s) (P=0.034), in watt 4 (95%CI −33 to 41, 0.048), and in METs 0.2 (95%CI −1.4 to 1.8) (P=0.048) in the ASC group while there was a nonsignificant increase in the placebo group in time duration 9 s (95%CI −203 to 221 s) (P=0.053), in watt 7 (95%CI −40 to 54) (P=0.41), and in METs 0.1 (95%CI −1.7 to 1.9) (P=0.757). The difference between the groups was not significant (P=0.680, P=0.608, and P=0.720 for time duration, watt, and METs, resp.). Intramyocardial delivered VEGF-A165-stimulated ASC treatment was safe but did not improve exercise capacity compared to placebo. However, exercise capacity increased in the ASC but not in the placebo group. This trial is registered with ClinicalTrials.gov NCT01449032.http://dx.doi.org/10.1155/2017/5237063
spellingShingle Abbas Ali Qayyum
Anders Bruun Mathiasen
Naja Dam Mygind
Jørgen Tobias Kühl
Erik Jørgensen
Steffen Helqvist
Jens Jørgen Elberg
Klaus Fuglsang Kofoed
Niels Groove Vejlstrup
Anne Fischer-Nielsen
Mandana Haack-Sørensen
Annette Ekblond
Jens Kastrup
Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study
Stem Cells International
title Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study
title_full Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study
title_fullStr Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study
title_full_unstemmed Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study
title_short Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study
title_sort adipose derived stromal cells for treatment of patients with chronic ischemic heart disease mystromalcell trial a randomized placebo controlled study
url http://dx.doi.org/10.1155/2017/5237063
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