Abstract 3682: Treatment of Patients with Severe Angina Pectoris Using Intracoronarily Injected Autologous Blood-Borne Angiogenic Cell Precursors
Background A pilot clinical trial was carried out to assess the safety and efficacy of intracoronary injection of VesCellTM, an autologous Angiogenic Cell Precursor (ACP)-based product for the treatment of patients with chronic stable angina pectoris who were on maximal drug therapy.
Methods Twenty four patients were prospectively enrolled and treated with ACPs. The administration of the therapy was based upon identifying ischemic but viable myocardium (SPECT-MIBI scan) in the distribution of occluded coronary arteries. ACPs were prepared from cells separated from non-mobilized peripheral blood of each patient, cultured ex vivo and injected via a catheter with proximal balloon occlusion of the coronary artery. The patients were assessed clinically pretreatment and at 1, 3 and 6 months after treatment using the following parameters: Canadian Cardiovascular Society (CCS) Scale, six minute walk (6MW) test, exercise capacity as assessed by metabolic equivalents (METs) and SPECT-MIBI perfusion defect.
Results Twenty patients have completed 3 months follow up and 17 have completed 6 months follow up. The other patients are scheduled to complete the follow up period before the end of this year. The clinical condition improved in all patients at 3 and 6 months vs. pretreatment, 6MW increasing from 333.65±26.56 to 414.95±28.54 meters at 3 months and to 413.25±33.17 meters at 6 months (both P<0.001); exercise capacity increasing from 5.62±0.52 to 6.73±0.64 METs at 3 months (P<0.004) and to 7.09±0.79 METs at 6 months (P<0.04); perfusion defect decreasing from 38.46±6.19% to 23.89±5.79% at 3 months (P<0.004) and to 21.05±5.16% at 6 months (P<0.005); and mean CCS score decreasing from 2.1±0.19 to 1.05±0.05 at 3 months and to 1.18±0.13 at 6 months (both P<0.001).One patient died two weeks after the treatment due to acute myocardial infarction. Coronary angiography demonstrated occlusion in an untreated artery and patency of the VesCellTM-treated artery.
Conclusion VesCell™ therapy for chronic stable angina seems to be safe and improves anginal symptoms at 3 and 6 months. Larger studies are being initiated to evaluate the benefit of VesCell™ for the treatment of this and additional severe heart diseases.