{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T04:16:05Z","timestamp":1792556165691,"version":"4.5.0"},"reference-count":32,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2020,5,18]],"date-time":"2020-05-18T00:00:00Z","timestamp":1589760000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000026","name":"Juventas Therapeutics","doi-asserted-by":"publisher","award":["This study was funded by Juventas Therapeutics. T"],"award-info":[{"award-number":["This study was funded by Juventas Therapeutics. T"]}],"id":[{"id":"10.13039\/100000026","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Endovasc Ther"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:p>Purpose: To present the 6-month results of the Stromal Cell\u2013Derived Factor-1 Plasmid Treatment for Patients with Peripheral Artery Disease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee. Materials and Methods: The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( ClinicalTrials.gov identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid\u2013based treatment vs placebo (n=34). The primary efficacy outcome was the 6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months. Results: Only one-third of the patients had complete wound healing at 6 months in the placebo (31%), 8-mg injection (33%), and 16-mg injection (33%) groups. In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups). During the 6-month period, 6 patients (6%) died, and 24 patients (23%) had an amputation [only 4 (4%) major]. Conclusion: Combining revascularization and biological therapy failed to improve outcomes in CLTI at 6 months. STOP-PAD has provided insights for future trials to evaluate biological therapy.<\/jats:p>","DOI":"10.1177\/1526602820919951","type":"journal-article","created":{"date-parts":[[2020,5,18]],"date-time":"2020-05-18T07:48:15Z","timestamp":1589788095000},"page":"669-675","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":17,"title":["Stromal Cell\u2013Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results"],"prefix":"10.1177","volume":"27","author":[{"given":"Tarek A.","family":"Hammad","sequence":"first","affiliation":[{"name":"Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Rundback","sequence":"additional","affiliation":[{"name":"Interventional Institute, Holy Name Medical Center, Teaneck, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Bunte","sequence":"additional","affiliation":[{"name":"Saint Luke\u2019s Mid America Heart Institute, St Luke\u2019s Hospital and University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie","family":"Miller","sequence":"additional","affiliation":[{"name":"BayCare Physician Partners, Clearwater, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parag D.","family":"Patel","sequence":"additional","affiliation":[{"name":"BayCare Physician Partners, Clearwater, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saihari","family":"Sadanandan","sequence":"additional","affiliation":[{"name":"St Joseph\u2019s Hospital, Tampa, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Fitzgerald","sequence":"additional","affiliation":[{"name":"Juventas Therapeutics, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Pastore","sequence":"additional","affiliation":[{"name":"Juventas Therapeutics, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vikram","family":"Kashyap","sequence":"additional","affiliation":[{"name":"Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy D.","family":"Henry","sequence":"additional","affiliation":[{"name":"The Christ Hospital, Cincinnati, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4888-2431","authenticated-orcid":false,"given":"Mehdi H.","family":"Shishehbor","sequence":"additional","affiliation":[{"name":"Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, 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