Abstract 2091: Clinical Trial of Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Severe Chronic Heart Failure
Background. Experimental studies have shown that transplantation of mesenchymal stem cells (MSCs) improves cardiac function in heart failure. However, little information is available regarding the therapeutic potency of MSCs in humans. The present study evaluated the safety and preliminary efficacy of transendocardial transplantation of autologous bone marrow MSCs in patients with severe chronic heart failure.
Methods and Results. This is a prospective, nonrandomized, open-labeled pilot study of 11 patients with severe chronic heart failure who have no other option for standard therapies. Approximately 20 ml bone marrow was harvested from iliac crests and 400 – 600 ml peripheral blood was collected to prepare serum for culture. Bone marrow cells were cultured in medium containing 15% auto serum for 3 weeks to expand adherent fibroblastic cells (MSCs), of which surface antigen expression was mesenchymal type. The cultured MSCs secreted large amounts of angiogenic, antiapoptotic and mitogenic factors such as vascular endothelial growth factor and hepatocyte growth factor. Three patients did not receive cell transplantation because of insufficient cell expansion, an episode of pulmonary edema related to baseline catheterization and bone marrow aspiration, or acute colitis unrelated to the study procedure. The remaining 8 patients (dilated cardiomyopathy in 5 and ischemic cardiomyopathy in 3) received transendocardial injections of 3.7 ± 0.8 × 107 MSCs into 40 different points of the LV wall with Myostar injection catheter. There were no periprocedual complications such as sustained ventricular arrhythmias and pericardial effusions, nor did any significant adverse effects such as bone formation in the myocardium at the 2-month follow-up. MSC transplantation significantly increased LV ejection fraction (23.9 ± 2.8% to 27.8 ± 2.7%, P < 0.05). MSC also increased stroke volume index (35.3 ± 3.4% to 39.4 ± 3.1%, P < 0.05) without significant changes in LV volume. Plasma BNP level significantly decreased after MSC transplantation.
Conclusions. This preliminary study suggests the safety and short-term efficacy of transendocardial injection of autologous bone marrow MSCs in patients with severe chronic heart failure.