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Background & objectives: Acute myocardial infarction (AMI) is characterized by irreparable and irreversible loss of cardiac myocytes. Despite major advances in the management of AMI, a large number of patients are left with reduced left ventricular ejection fraction (LVEF), which is a major determinant of short and long term morbidity and mortality. A review of 33 randomized control trials has shown varying improvement in left ventricular (LV) function in patients receiving stem cells compared to standard medical therapy. Most trials had small sample size and were underpowered. This phase III prospective, open labelled, randomized multicenteric trial was undertaken to evaluate the efficacy in improving the LVEF over a period of six months, after injecting a predefined dose of 5-10 × 108 autologous mononuclear cells (MNC) by intra-coronary route, in patients, one to three weeks post ST elevation AMI, in addition to the standard medical therapy. Methods: In this phase III prospective, multicentric trial 250 patients with AMI were included and randomized into stem cell therapy (SCT) and non SCT groups. All patients were followed up for six months. Patients with AMI having left ventricular ejection fraction (LVEF) of 20-50 per cent were included and were randomized to receive intracoronary stem cell infusion after successfully completing percutaneous coronary intervention (PCI). Results: On intention-to-treat analysis the infusion of MNCs had no positive impact on LVEF improvement of ≥ 5 per cent. The improvement in LVEF after six months was 5.17 ± 8.90 per cent in non SCT group and 4.82 ± 10.32 per cent in SCT group. The adverse effects were comparable in both the groups. On post hoc analysis it was noted that the cell dose had a positive impact when infused in the dose of ≥ 5 X 108 (n=71). This benefit was noted upto three weeks post AMI. There were 38 trial deviates in the SCT group which was a limitation of the study. Interpretation & conclusions: Infusion of stem cells was found to have no benefit in ST elevation AMI. However, the procedure was safe. A possible benefit was seen when the predefined cell dose was administered which was noted upto three weeks post AMI, but this was not significant and needs confirmation by larger trials.
RESUMO
BACKGROUND: Infection with cytomegalovirus (CMV) is more common in developing nations and the people belonging to the lower socioeconomic section of the society. The immunosuppressed population for whom CMV-seronegative blood products are requested is increasing due to advances in medical care. AIM: To study the prevalence of CMV antibodies among the different sexes and age groups in healthy blood donors. MATERIALS AND METHODS: A retrospective study was done on 5600 serum samples stored frozen in a repository for CMV antibodies using the ELISA technique. RESULTS: Five thousand three hundred and fifty (95.5%) were male and 250 (4.5%) were female. Four cases (0.071%) out of 5600 samples were positive for anti-IgM CMV with 95% Confidence Interval (95% C.I) of 0.02 - 0.17. CONCLUSION: In a developing country like India, screening for IgM antibody on a routine basis may not be feasible, given the likely positive yield to be low and the cost being high. It is recommended that in a tertiary care hospital, blood units to be transfused to neonates, organ transplant recipients, those suffering from malignancies and other immunocompromised patients should be screened for anti-IgM CMV or preventive strategies like universal leucodepletion to be implemented to decrease the transmission of CMV in these groups of patients.