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

Medientyp: E-Artikel
Titel: Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study
Beteiligte: Qayyum, Abbas Ali; Mathiasen, Anders Bruun; Mygind, Naja Dam; Kühl, Jørgen Tobias; Jørgensen, Erik; Helqvist, Steffen; Elberg, Jens Jørgen; Kofoed, Klaus Fuglsang; Vejlstrup, Niels Groove; Fischer-Nielsen, Anne; Haack-Sørensen, Mandana; Ekblond, Annette; Kastrup, Jens
Erschienen: Hindawi Limited, 2017
Erschienen in: Stem Cells International
Sprache: Englisch
DOI: 10.1155/2017/5237063
ISSN: 1687-966X; 1687-9678
Schlagwörter: Cell Biology ; Molecular Biology
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Beschreibung: <jats:p>We aimed to evaluate the effect of intramyocardial injections of autologous VEGF-A<jats:sub>165</jats:sub>-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-A<jats:sub>165</jats:sub>. At 6 months follow-up, bicycle exercise tolerance increased significantly in time duration 22 s (95%CI −164 to 208 s) (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M1"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn>0.034</mml:mn></mml:math>), in watt 4 (95%CI −33 to 41, 0.048), and in METs 0.2 (95%CI −1.4 to 1.8) (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn>0.048</mml:mn></mml:math>) 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) (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M3"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn>0.053</mml:mn></mml:math>), in watt 7 (95%CI −40 to 54) (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M4"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn>0.41</mml:mn></mml:math>), and in METs 0.1 (95%CI −1.7 to 1.9) (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M5"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn>0.757</mml:mn></mml:math>). The difference between the groups was not significant (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M6"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn>0.680</mml:mn></mml:math>, <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M7"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn>0.608</mml:mn></mml:math>, and <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M8"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn>0.720</mml:mn></mml:math> for time duration, watt, and METs, resp.). Intramyocardial delivered VEGF-A<jats:sub>165</jats:sub>-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 <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01449032?term=01449032&rank=1">NCT01449032</jats:ext-link>.</jats:p>
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