Table 3.
Clinical studies of gene targeting in Ischemic Heart Disease utilizing viral vectors
Reference | Trial/Design | Number of Patients | Therapeutic Agent | Delivery | Endpoints | Outcomes | Major Adverse Events |
---|---|---|---|---|---|---|---|
[56] | Phase I | 21 | AdV-VEGF-A121 | Intramyocardial injections | CCS; NTG/week | Improvement trend; Improvement trend | None |
| |||||||
[57] | AGENT RCT | 79 | AdV-FGF-4 | Intracoronary infusion | Stress-induced Wall Motion; | No change; | None |
ETT | Improved | ||||||
| |||||||
[58] | AGENT-2 RCT | 52 | AdV-FGF-4 | Intracoronary infusion | Perfusion Defect Size; | No change | None |
Angina/week; | No change | ||||||
NTG/week | No change | ||||||
| |||||||
[59] | KAT Phase II | 103 | AdV-VEGF-A165 vs VEGF-A165 (plasmid) | Intracoronary infusion | Myocardial perfusion (SPECT); CCS | Improved (AdV), No change (plasmid); No change (AdV & plasmid) | Death (n=1), Transient fever (n=19, Adv; n=11, plasmid) |
| |||||||
[60] | REVASC Phase II | 67 | AdV-VEGF-A121 | Intramyocardial injection—mini-thoracotomy | Myocardial perfusion (SPECT); | No change; | Death (n=1) |
CCS | Improved | ||||||
| |||||||
[61] | AGENT-3 & AGENT-4 RCT | 532 | AdV-FGF-4 | Intracoronary infusion | ETT; CCS; | No change; Improved(gender bias); | None |
Angina/week; NTG/week | No change; No change |
AdV, adenoviral vector; VEGF, vascular endothelial growth factor; CCS, Canadian Cardiovascular Society functional classification of angina; NTG, nitroglycerine tablets; RCT, randomized controlled trial; FGF, fibroblast growth factor; ETT, exercise tolerance time; CK, creatine kinase; SPECT, single photon emission computerized tomography