SDF-1 plasmid treatment for patients with peripheral artery disease (STOP-PAD): Randomized, double-blind, placebo-controlled clinical trial

Vascular Medicine
Mehdi H ShishehborTimothy D Henry

Abstract

The 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. Patients were eligible if they persistently had reduced forefoot perfusion, by toe-brachial index (TBI) or skin perfusion pressure (SPP), following successful revascularization with angiographic demonstration of tibial arterial flow to the ankle. The primary efficacy end point was a 3-month wound healing score assessed by an independent wound core laboratory. The primary safety end point was major adverse limb events (MALE). Patients' mean age was 71 years, 33% were women, 79% had diabetes, and 8% had end-stage renal disease. TBI after revascularization was 0.26, 0.27, and 0.26 among the three groups (placebo, 8 mg, and 16 mg injections, respectively). Only 26% of wounds completely healed at 3 month...Continue Reading

References

May 27, 2003·Diabetes Care·William A MarstonUNKNOWN Dermagraft Diabetic Foot Ulcer Study Group
Oct 17, 2009·Journal of Cardiovascular Pharmacology·Cristiano SpadaccioMassimo Chello
Oct 5, 2010·The American Journal of Pathology·Marc S Penn
Jun 8, 2012·Gene Therapy·M S PennR Aras
Aug 3, 2012·Journal of Vascular Surgery·Neal R BarshesUNKNOWN Model To Optimize Healthcare Value in Ischemic Extremities 1 (MOVIE) Study Collaborators
May 15, 2013·Nature Reviews. Cardiology·Brian H Annex
Oct 23, 2014·Circulation. Cardiovascular Interventions·Mehdi H Shishehbor, Grant W Reed
May 11, 2016·Circulation. Cardiovascular Interventions·Mehdi H Shishehbor, Tarek A Hammad
Oct 30, 2016·Journal of the American College of Cardiology·Mehdi H ShishehborMichael R Jaff
Dec 14, 2016·Circulation·Mehdi H Shishehbor, Michael R Jaff
Mar 11, 2017·Journal of the American College of Cardiology·Mehdi H Shishehbor, Herbert D Aronow
Mar 11, 2017·Journal of the American College of Cardiology·Shikhar AgarwalBadal Thakkar
Sep 2, 2017·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Tarek A HammadMehdi H Shishehbor
Feb 13, 2018·JACC. Basic to Translational Science·Sunil R Iyer, Brian H Annex

❮ Previous
Next ❯

Citations

May 8, 2020·Circulation Research·Antonio CannatàMauro Giacca
May 19, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Tarek A HammadMehdi H Shishehbor
May 22, 2020·Arteriosclerosis, Thrombosis, and Vascular Biology·John P Cooke, Shu Meng
Apr 22, 2021·Circulation Research·Evelina VågesjöMia Phillipson
Sep 21, 2021·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Jun LiMehdi H Shishehbor

❮ Previous
Next ❯

Methods Mentioned

BETA
amputation
amputations

Clinical Trials Mentioned

NCT02544204

Software Mentioned

Integrium
Interactive Web Response System ( IWRS )
SAS

Related Concepts

Related Feeds

CREs: Gene & Cell Therapy

Gene and cell therapy advances have shown promising outcomes for several diseases. The role of cis-regulatory elements (CREs) is crucial in the design of gene therapy vectors. Here is the latest research on CREs in gene and cell therapy.

Brain Injury & Trauma

brain injury after impact to the head is due to both immediate mechanical effects and delayed responses of neural tissues.