[Application of VEGF165 plasmid in treatment of critical lower limb ischemia]

In the study we assessed the clinical and histological benefits of gene therapy in no-option patients with critical lower limb ischemia.

We administrated VEGF165 (Vascular Endothelial Growth Factor) plasmid to 10 patients. The plasmid was injected intramuscularly into lower limb. In the study we evaluated: clinical outcomes, venous blood VEGF protein concentration before and after (7th, 14th, 28th and 90th day) administration of plasmid. From patients who required amputation we obtained samples of muscles, which were examined histological and by PCR (Polymerase Chain Reaction) for detection of plasmid genes.

Only two patients from the group did not require amputation due to the therapy. In eight patients the operation was essential. Serum VEGF concentration was higher than in healthy controls (p < 0.05). We observed increase of the concentration of the cytokine on the 14th day an decrease on the 90th day after administration of plasmid (p < 0.05). Histological analysis did not reveal any sings of new blood vessels formation in the samples taken from amputated limbs. There was also no signs of expression of plasmid primers in PCR.

The therapy is safe. We did not observe significant improvement in patient's clinical state. The therapy needs further investigations.