Trial | Disease | Therapeutic factor | Route of administration | Control treatment | n | Primary end point | Results* | Reference |
EUROINJECT-ONE | CAD (CCS III–IV) | Naked VEGF165 plasmid | Percutaneous intramyocardial injections | Control plasmid | 74 | Improved myocardial perfusion at 3 months | Negative | 42 |
GENASIS | CAD (CCS III–IV) | Naked VEGF-2 (VEGF-C) plasmid | Percutaneous intramyocardial injections | Vehicle | 295 (404 planned) | ETT at 3 months | Negative at interim analysis, stopped | http://www.medicalnewstoday.com 11 Oct 200636 (Unpublished) |
NORTHERN | CAD (CCS III–IV) | Naked VEGF165 plasmid | Percutaneous intramyocardial injections | Vehicle | 120 (planned) | Change in myocardial perfusion in stress/rest at 12 weeks | Negative | 43 |
VIF-CAD | CAD (CCS III–IV) | Naked bicistronic VEGF-A165/FGF-2 plasmid | Percutaneous intramyocardial injections | Control plasmid | ? | SPECT at 4 months | Ongoing | http://www.clinicaltrials.gov (Unpublished) |
DELTA-1 | PAD (claudication) | Plasmid-expressing Del-1 formulated with poloxamer 188 | Intramuscular injections | Vehicle | 157 | PWT at 3 months | Negative | 47 |
Groningen | PAD (CLI) | Naked VEGF165 Plasmid | Intramuscular injections | Saline | 54 | Decrease in amputation rate | Negative (secondary end points positive) | 44 |
HGF-STAT | PAD (CLI) | Naked HGF plasmid | Intramuscular injections | Saline | 104 | Wound healing, amputation rate, rest pain, ABI | Negative | 46 |
TALISMAN 201 | PAD (CLI) | Naked FGF-1 plasmid | Intramuscular injections | Vehicle | 125 | Ulcer healing at 6 months | Negative (secondary end point of reduced amputation positive) | 45 |
TAMARIS | PAD (CLI) | Naked FGF-1 plasmid | Vehicle | 490 (planned) | Amputation or death | Ongoing | 45 |
↵* Efficacy based on the defined primary or secondary end point.
ABI, ankle brachial index; Ad, adenovirus; CAD, coronary artery disease; CCS, Canadian Cardiovascular Society; CLI, critical limb ischaemic; ETT, exercise tolerance test; FGF, fibroblast growth factor; HGF, hepatocyte growth factor; PAD, peripheral arterial disease; PWT, peak walking time; SPECT, single-photon emission computed tomography; VEGF, vascular endothelial growth factor.