Results of 5-year observation of patients with diseases of peripheric arteries after gene therapy

This study included patients who were in a clinical study evaluating the safety and efficacy of gene therapy with pl-VEGF165 in patients with chronic ischemia of the lower extremities of atherosclerotic origin (ClinicalTrials.gov: NCT03068585). In just 5 years the study included 36 patients who received a gene therapy drug and 12 patients in the control group. Patients were registered for adverse events, as well as an assessment of the pain-free walking distance (PWD), ankle-brachial index (ABI), transcutaneous oxygen pressure (TcPO2). There were no side effects associated with the use of pl-VEGF165. Differences in the incidence of adverse cardiovascular events (pl-VEGF165 5/36 versus 2/12 in control, P = 0,85), oncological diseases (pl-VEGF165 1/36 vs 0/12 in control, P = 0,38) and visual impairment (not recorded in both groups) over the 5-year follow-up period did not reach statistical significance. The safety of the target limb was 95% in the clinical group and 67% in the control group...