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In a separate protocol VesCell™ was administered intramyocardially to 91 patients. This was either done thoracoscopically or at time of Coronary bypass grafting. Of these, at baseline,50 had non-ischemic cardiomyopathy, 31 had ischemic cardiomyopathy, and 9 had both ischemic cardiomyopathy and angina pectoris (table 5). Patients' age ranged from 27.8 to 84.2; there were 77 male and 14 female patients (table 1&3). Mean baseline NYHA classification score was 2.7 ± 0.7, and mean % rest EF ( measured by echocardiography at patients's s home countries) was 23.8 ± 10.7.
Patients with baseline % EF ≤40 for whom follow up data was available (24 patients) showed improved cardiac function at 2-4 & 4-8 months follow up, mean ejection fraction improving from 21.1 ± 1.56 to 26.92 ± 1.88 & 29.24 ± 1.89 (mean + SE) at P<0.002. The clinical condition of patients assessed subjectively according to the NYHA score also showed improvement; a decrease in from 2.65 ± 0.67 to 1.83 ± 0.79 & 1.57 ± 0.77 presented as mean ± SD (n=45, P<0.001); moreover, BNP level decreased also (mean ± SE) from 3,965 ± 836.4 to 1,508 ± 445.2 pg/ml at 2-4 months post treatment (n= 16 , P<0.03). The clinical condition of patients assessed subjectively according to the CCS score showed a decrease of mean ± SE from 2.36 ± 0.28 to 1.5 ± 0.24 (n=7, P<0.004).
Cell transplantation far myocardial repair defines a new era in the treatment of cardiovascular disease, stan cell biology heralds a new promise for an alternative therapy. Stem cells present an unprecedented opportunity to compensate for the inadvertent loss of cardiomyocytes that accompanies MI, and which initiates a cascade of events leading lo eventual heart failure.
At the moment we would recommend Stem Cell Therapy only for patients with no other options i.e. patients who cannot be treated with Coronary Artery Bypass Graft Surgery, Percutaneous Coronary Intervention, medical treatment. The indication for Stem Cell Therapy may widen when more trials have been carried out.
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