SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
NCT ID: NCT02544204
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2015-11-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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8 mg JVS-100
Biological/Vaccine: JVS-100 Injection Intramuscular Injection
JVS-100
Biological/Vaccine: JVS-100 Intramuscular Injection
8 mg placebo
Biological/Vaccine: Placebo Injection Intramuscular Injection
Placebo
Biological/Vaccine: Placebo Intramuscular Injection
16 mg JVS-100
Biological/Vaccine: JVS-100 Injection Intramuscular Injection
JVS-100
Biological/Vaccine: JVS-100 Intramuscular Injection
16 mg placebo
Biological/Vaccine: Placebo Injection Intramuscular Injection
Placebo
Biological/Vaccine: Placebo Intramuscular Injection
Interventions
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JVS-100
Biological/Vaccine: JVS-100 Intramuscular Injection
Placebo
Biological/Vaccine: Placebo Intramuscular Injection
Eligibility Criteria
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Inclusion Criteria
* Currently receiving standard of care wound treatment (\>2 weeks) for chronic wounds or gangrene including as indicated: debridement, pressure offloading, infection control, and/or maintenance of a moist wound environment.
* Diagnosis of advanced PAD with tissue loss (ulceration and/or dry gangrene) on the foot of the index leg with an ulcer size of at least 0.5 cm2 and \<25 cm2. Index wounds on the heel must be \<10 cm2 that cannot be probed to bone, have exposed bone or osteomyelitis.
* TBI ≤ 0.51or;
* Toe pressure ≤50 mmHg with flat or dampened wave forms or;
* Skin Perfusion pressure ≤40 mmHg at mid foot level or;
* TcPO2 ≤40 mmHg
* Subjects willing to forgo treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of advanced PAD from time of consent to 6 months following the initial injection of study drug
Exclusion Criteria
* Only a short segment superficial femoral artery lesion - consistent with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A or B category, and no infrapopliteal disease
* Staged or planned intervention in the index leg within 30 days after the index procedure
* Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease
* Non-salvageable limb defined as major tissue loss and an unsalvageable foot;
* Wounds that have decreased in size by \>50% between the Screening visit and Day 0.
* If patient has active infection of the index limb that is being treated, and, in the opinion of treating physician, will not lead to an amputation within the next 3 months, the patient can be enrolled.
* Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition.
* Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
18 Years
ALL
No
Sponsors
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Juventas Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Cardiovascular Associates of the Southeast
Birmingham, Alabama, United States
UC Davis
Davis, California, United States
Cedars-Sinai Heart Institute
Los Angeles, California, United States
MedStar Georgetown UH
Washington D.C., District of Columbia, United States
Morton Plant Hosptial - Baycare
Clearwater, Florida, United States
Mount Sinai Medical Center
Miami, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
Northwestern
Chicago, Illinois, United States
RUMC
Chicago, Illinois, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Mayo
Rochester, Minnesota, United States
Cardiology Associates Research
Tupelo, Mississippi, United States
St. Luke's Mid America Heart Institute
Kansas City, Missouri, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
UNC
Chapel Hill, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Summa Health
Akron, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Metro Health
Cleveland, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
Lifespan Health System
Providence, Rhode Island, United States
VCU
Richmond, Virginia, United States
Medical College of Wisconsin
Milwauke, Wisconsin, United States
Countries
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Facility Contacts
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Chris Huff, MD
Role: primary
John Laird, MD
Role: primary
Tim Henry, MD
Role: primary
Paul Kim, MD
Role: primary
Les Miller, MD
Role: primary
Nirat Beohar, MD
Role: primary
Sai Sadanandan, MD
Role: primary
Karen Ho, MD
Role: primary
Jeff Snell, MD
Role: primary
Craig Walker, MD
Role: primary
Tom Davis, MD
Role: primary
Sanjay Misra, MD
Role: primary
Murray Estess, MD
Role: primary
Matt Bunte, MD
Role: primary
John Runback, MD
Role: primary
William Marston, MD
Role: primary
Matt Hook, MD
Role: primary
Justin Dunn, MD
Role: primary
Mehdi Shishehbor, DO
Role: primary
Sanjay Gandhi, MD
Role: primary
Vikram Kashyap, MD
Role: primary
Peter Soukas, MD
Role: primary
Luis Guzman, MD
Role: primary
James Gossett, MD
Role: primary
References
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Hammad TA, Rundback J, Bunte M, Miller L, Patel PD, Sadanandan S, Fitzgerald M, Pastore J, Kashyap V, Henry TD, Shishehbor MH. Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results. J Endovasc Ther. 2020 Aug;27(4):669-675. doi: 10.1177/1526602820919951. Epub 2020 May 18.
Shishehbor MH, Rundback J, Bunte M, Hammad TA, Miller L, Patel PD, Sadanandan S, Fitzgerald M, Pastore J, Kashyap V, Henry TD. SDF-1 plasmid treatment for patients with peripheral artery disease (STOP-PAD): Randomized, double-blind, placebo-controlled clinical trial. Vasc Med. 2019 Jun;24(3):200-207. doi: 10.1177/1358863X18817610. Epub 2019 Feb 21.
Other Identifiers
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JTCS-007
Identifier Type: -
Identifier Source: org_study_id