Gene Therapy for Peripheral Arterial Disease and Nursing Implications: Clinical Experience on the use of Sendai Viral Vector : Table 1

Table 1: Selected PAD Gene Therapy Trials.
*Outcomes were evaluated for only primary endpoints and did not include any improvement in secondary endpoints.

Angiogenic factors	Phase	Patients	No. of subjects (treated/controls)	Treatment	Vector	Primary endpoints	Outcome*
VEGF	I	CLI	9/-	pCK-VEGF₁₆₅	Plasmid	Safety	Positive
VEGF	I	CLI	21/-	phVEGF₁₆₅	Plasmid	Safety	Positive
VEGF	I	IC	15/3	adVEGF₁₂₁	Adenovirus	Safety	Equivocal
VEGF	II	CLI	27/27	phVEGF₁₆₅	Plasmid	Amputation	Negative
VEGF	II	IC	72/33	adVEGF₁₂₁	Adenovirus	Peak walking time	Negative
VEGF	II	IC/CLI	18/17/19	adVEGF₁₆₅/ phVEGF₁₆₅	Adenovirus/plasmid	Increased vascularity	Positive
HGF	I	CLI	78/26	pVAX1-HGF	Plasmid	Safety/TcPO₂	Positive
HGF	I	CLI	22/-	pVAX1-HGF	Plasmid	Safety/ABI, ulcer size	Positive
HGF	I	CLI	21/-	pCK-HGF-X7	Plasmid	Safety and tolerability	Positive
HGF	II	CLI	21/6	VM202	Plasmid	Safety/ABI, VAS, ulcer	Positive
HGF	III	CLI	30/14	pVAX1-HGF	Plasmid	Rest pain, ulcer size	Positive
FGF-1	I	CLI	51/-	NV1FGF	Plasmid	Safety	Positive
FGF-1	II	CLI	51/56	NV1FGF	Plasmid	Ulcer healing	Negative
FGF-1	III	CLI	259/266	NV1FGF	Plasmid	Amputation or death	Negative
FGF-2	I	CLI	12/-	rSeV/df-hFGF-2	Sendai virus	Safety and tolerability	Positive
FGF-2	II	IC	127/63	rFGF2	Plasmid	Maximum walking time	Positive
HIF-1	I	CLI	34/7	Ad2/HIF-1α/VP16	Adenovirus	Safety and efficacy	Positive
HIF-1	II	CLI	213/76	Ad2/HIF-1α/VP16	Adenovirus	Maximum walking time	Negative
DEL-1	II	IC	52/53	VLTS-589	Plasmid	Maximum walking time	Negative