Table 1 Summary of clinical trials using angiogenic growth factor genes for patients with PAD.
| Trials or author name [reference] | Vector and promoter | Delivery route | Phase | Enrollment | Outcomes |
|---|---|---|---|---|---|
| Baumgartner et al. [34] | phVEGF165/ MIEhCMV | Intra-muscular | I | 9 | Tolerated |
| Mäkinen et al. [35] | phVEGF165/ MIEhCMV | Intra-arterial | II | 54 | Tolerated, increase vascularity |
| AdVEGF165/ MIEhCMV | |||||
| RAVE [36] | AdVEGF121/ MIEhCMV | Intra-muscular | II | 95 | No improvement of exercise performance or QOL |
| Groningen [37] | phVEGF165/ not reported | Intra-muscular | II | 54 | No reduction in amputation rate |
| Comerota et al. [45] | phFGF-1/MIEhCMV | Intra-muscular | I | 107 | Tolerated |
| TALISMAN [46] | phFGF-1/MIEhCMV | Intra-muscular | II | 125 | Reduction in amputation rate |
| TAMARIS [47] | phFGF-1/ MIEhCMV | Intra-muscular | III | 525 | No improvement of QOL or ABI, no reduction in amputation rate or death |
| Morishita et al. [50] | phHGF/ MIEhCMV | Intra-muscular | I/IIa | 22 | Tolerated |
| Makino et al. [53] | phHGF/ MIEhCMV | Intra-muscular | I/IIa | 22 | Improvement of ABI, reduction in rest pain and ulcer size up to 2 years |
| HGF-STAT [51] | phHGF/ MIEhCMV | Intra-muscular | II | 104 | Improvement in TcPO2 |
| TREAT-HGF [52] | phHGF/ MIEhCMV | Intra-muscular | III | 40 | Improvement in rest pain and ABI, reduction in ulcer size |
ABI: ankle-brachial index; TcPO2: transcutaneous oxygen tension; MIEhCMV: major immediate-early enhancer/promoter from human cytomegalovirus