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ORLANDO -- A novel gene therapy treatment for critical limb ischemia -- the non-viral DNA plasmid-based therapy encoding for stromal cell-derived factor-1, dubbed JVS-100 -- did not improve wound healing when added to revascularization, researchers reported here.
The randomized, double-blind trial of 109 patients showed no advantage to either dose of the agent used in improving wound healing score, and the lower dose actually trended toward more wound progression compared with placebo.
For the key safety endpoint of major amputation plus clinically driven target lesion revascularization, the same pattern was seen, Mehdi Shishehbor, DO, MPH, PhD, of University Hospitals Harrington Heart and Vascular Institute in Cleveland, reported at the American College of Cardiology annual meeting.
"The wound definition was good; the results were unfortunate," Marie Gerhard-Herman, MD, of Brigham and Women's Hospital in Boston, commented as a discussant at the late-breaking clinical trial session.
"There's no shame in these results," said Gregory Piazza, MD, also of Brigham and Women's Hospital, who noted that the results are very similar to what has been seen with gene therapy in critical limb ischemia. He suggested that it's time to go back to pathophysiology before any more such trials.
Disclosures
Shishehbor disclosed relationships with Abbott.
Primary Source
American College of Cardiology meeting
Shishehbor MH, et al "A phase II randomized double-blind, placebo controlled study in patients with critical limb ischemia to evaluate the safety and efficacy of hSDF-1 plasmid (JVS-100) post open or endovascular revascularization to enhance wound healing" ACC 2018; Abstract 409-08.