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Patient's age ranged from 51 to 77 (63.6 ± 8.6); there were 18 male and 6 female patients. Mean baseline Canadian Cardiovascular Society (CCS) Score 2.17 ± 0.18. One patient died two weeks following a myocardial infarction which occurred one month after the administration of cell therapy. Coronary catheterization immediately following the MI determined that the infraction occurred in a region of the heart supplied by another, stead, coronary artery and not the one in which the cells were injected.
Final trial results show that symptoms of all 23 surviving patients improved significantly at 3 months vs. baseline, with the improvement persisting to 6 months.
Six minuet walk test improved from 347m to 427 m ( p<0.001) and CCS improved from 2.2 to 1.1 (p<0.001)
Since that initial study, VesCell™ was administered intracoronarily to 118 patients. Of these, at baseline, 13 had angina pectoris, 45 had ischemic cardiomyopathy, 59 had both ischemic cardiomyopathy and angina pectoris, and the rest is other type of CAD (table 5). Patients' age ranged from 38.4 to 94.6; there were 109 male and 9 female patients( table 1&3). Mean baseline NYHA score was 2.6 ± 0.7, and mean % rest EF (measured by echocardiography at patients' home countries) was 27.8 ± 12.5.
Patients whom follow up data was available showed improved cardiac function at 2-4 & 4-8 months follow up, mean ejection fraction improving from 34.56 ± 3.97 to 42.30 ± 3.57 & 40.07 + 3.34 (mean + SD) at P < 0.05. Patients with baseline ≤ 40 for whom follow up data was available (14 patients) showed improved cardiac function at 2-4 & 4-8 moths follow up, mean ejection fraction improving from 25.27 ± 1.76 to 36.85 ± 2.96 & 33.85 ± 2.99 ( mean + SE) at P<0.01. The clinical condition of patients assessed subjectively according to the NYHA scare also showed improvement; a decrease in from 2.82 ± 0.56 to 2.0 ± 0.68 & 1.6 + 0.67 presented as mean + SD (n=47, P<0.001). The clinical condition of patients assessed subjectively according to the CCS score showed a decrease of mean + SE from 2.72 ± 0.62 to 1.72 ± 0.73 (n=45, P<0.001).
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