To present the 6-month results of the tromal Cell-Derived Factor-1 Plasmid reatment fr atients with eripheral rtery isease (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. The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( 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-based treatment vs placebo (n=34).
View Article and Find Full Text PDFThe efficacy of biologic therapies in critical limb ischemia (CLI) remains elusive, in part, due to limitations in trial design and patient selection. Using a novel design, we examined the impact of complementing revascularization therapy with intramuscular JVS-100 - a non-viral gene therapy that activates endogenous regenerative repair pathways. In this double-blind, placebo-controlled, Phase 2B trial, we randomized 109 patients with CLI (Rutherford class V or VI) to 8 mg or 16 mg intramuscular injections of placebo versus JVS-100.
View Article and Find Full Text PDFA 91-year-old woman, presenting with flu-like symptoms, developed a brief episode of polymorphic ventricular tachycardia in the emergency department. The arrhythmia resolved spontaneously, and a subsequent electrocardiogram revealed Q waves and ST-segment elevation in the anterior precordial leads, along with a prolonged QT interval. The presumed diagnosis was ST-segment-elevation myocardial infarction with ischemia-induced ventricular tachycardia.
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