24613691
OBJECTIVE	Restenosis is a limitation of endovascular interventions performed in the superficial femoral artery ( SFA ) .
OBJECTIVE	Preclinical studies have demonstrated that the perivascular delivery of tissue-engineered allogeneic aortic endothelial cells ( PVS-10200 ) reduced stenosis in porcine models of SFA revascularization .
OBJECTIVE	The purpose of this study was to investigate the safety and feasibility of percutaneous PVS-10200 delivery after angioplasty and stenting in the SFA of patients with peripheral artery disease .
METHODS	In this phase I open-label trial , 21 patients ( average lesion length of 10.10 2.36 cm and 70 % stenosis ) were treated with PVS-10200 : 11 in a low-dose cohort ( cohort A ) and 10 in a high-dose cohort ( cohort B ) .
METHODS	The primary objective was to demonstrate the safety ( incidence of major adverse events ) of PVS-10200 within 4 weeks after surgery .
METHODS	Secondary end points included assessments of resting ankle-brachial index ( ABI ) in the treated leg , Fontaine class , and time to target lesion revascularization ( TLR ) .
RESULTS	No patient had a major adverse event within 4 weeks .
RESULTS	One patient required a limb amputation at 30 weeks .
RESULTS	At 48 weeks , cohort A and cohort B patients maintained a 37 % and 62 % increase in ABI compared with baseline , respectively ; 70 % of cohort A and 78 % of cohort B improved by 1 Fontaine classification stage , and the TLR rate was 39 % for cohort A and 20 % for cohort B.
CONCLUSIONS	Percutaneous local delivery of PVS-10200 is a well-tolerated and novel therapeutic approach that may be a suitable treatment for patients after endovascular intervention of the SFA .
CONCLUSIONS	Larger randomized trials are needed to determine if PVS-10200 can improve ABI and reduce TLR rates .

