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

• Published in: Stem cells international Vol. 2017; no. 2017; pp. 1 - 12
• Main Authors: Fischer-Nielsen, Anne, Haack-Sørensen, Mandana, Ekblond, Annette, Kastrup, Jens, Kofoed, Klaus Fuglsang, Elberg, Jens Jørgen, Helqvist, Steffen, Jørgensen, Erik, Kühl, Jørgen Tobias, Mygind, Naja Dam, Mathiasen, Anders Bruun, Qayyum, Abbas Ali, Vejlstrup, Niels Groove
• Format: Journal Article
• Language: English
• Published: Cairo, Egypt Hindawi Publishing Corporation 01.01.2017; Hindawi; Hindawi Limited; Wiley
• Subjects: Adipocytes; Analysis; Angina pectoris; Bicycles; Bone marrow; Cardiac patients; Cardiology; Cardiovascular disease; Care and treatment; Clinical Study; Clinical trials; Coronary artery; Coronary vessels; Disease control; Health aspects; Heart diseases; Heart failure; Ischemia; Medical imaging; Myocardial ischemia; Patients; Physiology; Placebos; Population; Randomization; Stem cells; Studies; Vascular endothelial growth factor
• ISSN: 1687-966X; 1687-9678; 1687-9678
• DOI: 10.1155/2017/5237063

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.