PMID- 32419594
OWN - NLM
STAT- MEDLINE
DCOM- 20201102
LR  - 20221207
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Linking)
VI  - 27
IP  - 4
DP  - 2020 Aug
TI  - Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral 
      Artery Disease (STOP-PAD) Trial: Six-Month Results.
PG  - 669-675
LID - 10.1177/1526602820919951 [doi]
AB  - Purpose: To present the 6-month results of the Stromal Cell-Derived 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-based 
      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.
FAU - Hammad, Tarek A
AU  - Hammad TA
AD  - Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical 
      Center and Case Western Reserve University School of Medicine, Cleveland, OH, 
      USA.
FAU - Rundback, John
AU  - Rundback J
AD  - Interventional Institute, Holy Name Medical Center, Teaneck, NJ, USA.
FAU - Bunte, Matthew
AU  - Bunte M
AD  - Saint Luke's Mid America Heart Institute, St Luke's Hospital and University of 
      Missouri-Kansas City School of Medicine, Kansas City, MO, USA.
FAU - Miller, Leslie
AU  - Miller L
AD  - BayCare Physician Partners, Clearwater, FL, USA.
FAU - Patel, Parag D
AU  - Patel PD
AD  - BayCare Physician Partners, Clearwater, FL, USA.
FAU - Sadanandan, Saihari
AU  - Sadanandan S
AD  - St Joseph's Hospital, Tampa, FL, USA.
FAU - Fitzgerald, Michael
AU  - Fitzgerald M
AD  - Juventas Therapeutics, Cleveland, OH, USA.
FAU - Pastore, Joseph
AU  - Pastore J
AD  - Juventas Therapeutics, Cleveland, OH, USA.
FAU - Kashyap, Vikram
AU  - Kashyap V
AD  - Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical 
      Center and Case Western Reserve University School of Medicine, Cleveland, OH, 
      USA.
FAU - Henry, Timothy D
AU  - Henry TD
AD  - The Christ Hospital, Cincinnati, OH, USA.
FAU - Shishehbor, Mehdi H
AU  - Shishehbor MH
AUID- ORCID: 0000-0002-4888-2431
AD  - Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical 
      Center and Case Western Reserve University School of Medicine, Cleveland, OH, 
      USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02544204
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200518
PL  - United States
TA  - J Endovasc Ther
JT  - Journal of endovascular therapy : an official journal of the International 
      Society of Endovascular Specialists
JID - 100896915
RN  - 0 (CXCL12 protein, human)
RN  - 0 (Chemokine CXCL12)
SB  - IM
MH  - Aged
MH  - Amputation, Surgical
MH  - Chemokine CXCL12/*biosynthesis/genetics
MH  - Chronic Disease
MH  - Double-Blind Method
MH  - Female
MH  - *Genetic Therapy/adverse effects
MH  - Humans
MH  - Ischemia/genetics/metabolism/physiopathology/*therapy
MH  - Limb Salvage
MH  - Male
MH  - *Neovascularization, Physiologic
MH  - Peripheral Arterial Disease/genetics/metabolism/physiopathology/*therapy
MH  - *Plasmids
MH  - Recovery of Function
MH  - Regional Blood Flow
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - Vascular Surgical Procedures
MH  - Wound Healing
OTO - NOTNLM
OT  - amputation
OT  - biological therapies
OT  - chronic limb-threatening ischemia
OT  - ischemic ulcer
OT  - lower extremity wound
OT  - microcirculation
OT  - peripheral artery disease
OT  - randomized controlled trials
OT  - revascularization
OT  - toe-brachial index
OT  - wound healing
EDAT- 2020/05/19 06:00
MHDA- 2020/11/03 06:00
CRDT- 2020/05/19 06:00
PHST- 2020/05/19 06:00 [pubmed]
PHST- 2020/11/03 06:00 [medline]
PHST- 2020/05/19 06:00 [entrez]
AID - 10.1177/1526602820919951 [doi]
PST - ppublish
SO  - J Endovasc Ther. 2020 Aug;27(4):669-675. doi: 10.1177/1526602820919951. Epub 2020 
      May 18.