MESENCHYMAL STROMAL CELL THERAPY IN HEART DISEASE
MESENCHYMAL STROMAL CELL THERAPY IN HEART DISEASE
J. Kastrup
The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
Background: We aimed to study the safety, feasibility and preliminary efficacy of ex-vivo expanded mesenchymal-derived endothelial progenitor cells for autologous cell transplantation to the heart, to improve vascularization in patients with severe myocardial ischemia.
Methods: A clinical trial including “no-option” patients with CCS 2-3 and reversible myocardial ischemia in an adenosine stress single photon emission computerized tomography. Primary endpoint is safety and feasibility of the treatment. Secondary endpoint is effect on angina. Bone marrow was aspirated by needle from the iliac crest. Mesenchymal stem cells were isolated and expanded in culture for 6-8 weeks. The last week cells were stimulated by rhVEGF-A165 to promote differentiation into endothelial progenitor cells. A total of 10 - 30 x106 cells were injected into a myocardial area of reversible ischemia using NOGA-guidance.
Results: 20 patients (age 68±7 years [mean±SD]) and sixteen controls (age 62±9 years) have been included in this “first-in-man” study. Autologous progenitor cell injections into the myocardium seem safe and feasible. Patients do not develop signs of inflammation or a tendency to arrhythmias. The patients with 3 and 6 months follow-up data had significant and sustained improvement in CCS-class, symptoms measured by Seattle angina questionnaire scores, angina frequency and nitroglycerine consumption compared to the control group.
Conclusion: The study demonstrates the feasibility and safety of autologous transplantation using ex-vivo expanded mesenchymal derived VEGF-stimulated endothelial progenitor cells, in order to induce vasculogenesis in patients with severe chronic occlusive coronary artery disease. Furthermore preliminary data suggest treatment-induced reduction of angina.
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