The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial

PHASE4RecruitingINTERVENTIONAL
Enrollment

386

Participants

Timeline

Start Date

June 20, 2024

Primary Completion Date

May 19, 2027

Study Completion Date

May 19, 2029

Conditions
Severe Lower Limb Ischemia
Interventions
DRUG

Deoxyribonucleic acid supercoiled plasmid pCMV-VEGF165 (Neovasculgen)

"The drug Neovasculgen is a highly purified supercoiled form of the pCMV-VEGF165 plasmid, encoding the Vascular endothelial growth factor (VEGF) under the control of a promoter (DNA control region). Recombinant plasmid DNA consists of the following components: a fragment of the regulatory region (22 nucleotide pairs), which determines the transcription of the gene, the VEGF minigene, upon expression of which the VEGF isoform is synthesized, consisting of 165 amino acids, a splicing signal, a polyadenylation signal and the SV40 transcription terminator, ensuring the synthesis of the mature RNA gene and auxiliary regions required for efficient biosynthesis of plasmid DNA in the cells of the producer strain of Escherichia coli. When molecules of this plasmid penetrate into mammalian cells, VEGF is produced, which stimulates endothelial cells, which leads to the growth of blood vessels (vascularization) in the area of injection."

Trial Locations (1)

675001

RECRUITING

Amur State Medical Academy, Blagoveshchensk

All Listed Sponsors
lead

Amur State Medical Academy

OTHER