Coronary artery diseaseSafety and Feasibility of Transendocardial Autologous Bone Marrow Cell Transplantation in Patients With Advanced Heart Disease
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Patient population
This was a nonrandomized, open-label, multicenter study. All patients underwent maximally tolerated medical therapy before the baseline assessment. Patients were eligible for this study if they met all the following inclusion criteria: (1) Canadian Cardiovascular Society (CCS) angina class III to IV; (2) ≥1 major epicardial vascular conduit with >70% obstruction and supplying the myocardial territory with reversible myocardial ischemia on dual-isotope single-photon emission computed tomographic
Patients
Patient characteristics are listed in Table 1. The average number of surgical and percutaneous revascularization procedures per patient was 1.5 ± 0.7 and 4.0 ± 4.0, respectively.
Bone marrow
Cell viability was ≥97% in all patients. The filtered BM had no clots or bone spicules, had normal morphology, and stained negative for bacteria. The BM aspiration and processing time was approximately 2.5 hours. The injected BM contained 28 ± 28 × 106/ml CD45+ cells (4 to 109 × 106/ml). The cell composition is detailed
Discussion
The main study results support the safety and feasibility of direct, transendocardial autologous BM injection in patients with advanced coronary artery disease. The study results also suggest the potential efficacy, with clinical benefit sustained to 1 year.
The results of the present study extend our preliminary observations,5 underscoring the intermediate-term safety of autologous direct intramyocardial BM cell injections. During the first 6 months after the autologous BM injection, 4 patients
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This research was supported by grants from the Cardiovascular Research Institute, Washington, DC, and the Cardiovascular Research Foundation, New York, New York, and a grant from MediVas LLC, San Diego, California.
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Dr. Fuchs, Kornowski, Leon, and Epstein are minor shareholders in a startup company dedicated to the field of cell therapy for angiogenesis.