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Here we report, for the first time in Cuba, the evaluation of the positive therapeutic action and safety in a pilot clinical trial for ischemic cardiac arrhythmia, of a gene therapy using a plasmid expressing the vascular endothelial growth factor isoform 121 gene (pVEGF121). Six patients irrespective of sex or race, with ages between 49 and 71, were included. They were refractory to conventional medical treatment and discharged as candidates for surgical revascularization procedures or interventionist cardiology. The pVEGF121 was administered as a single dose of 0.5 mg/mL, by intramyocardial route in four sites of the ischemic area (250 µL/site), previously defined by SPECT imaging by the surgical team and during a minimal left thoracotomy. Six months later, patients improved their clinical status after therapy, with partial regression in the treated ischemias, increasing quality of life and life expectancy. Plasmid transfection and VEGF expression were also evidenced. Two deaths were the adverse events reported, by myocardial infarction, probably due to perioperative complications derived from surgical risks and the critical status of the patients. Several parameters indicated that pVEGF121 administration did not cause adverse events per se, demonstrating that less invasive myocardial treatment alternatives are required to evaluate this product in other clinical phases. [ABSTRACT FROM AUTHOR]

The article presents a study which discussed the plasmid DNA production for gene therapy and therapeutic or preventive vaccination in humans. The plasmid DNA purification technique at the laboratory level allows to obtain DNA for experiments like sequencing and gene mapping. The efficient high-scale production of pharmaceutical grade plasmid DNA makes up an engineering task demanding experience and a high technical level.