SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease

Peripheral Arterial Disease Clinical Trial

— STOP-PAD  

Official title:

A Phase 2B Randomized Double Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection as Adjunct to Revascularization of Infrapopliteal Lesions in Subjects With Advanced Peripheral Artery Disease and Tissue Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02544204
• Other study ID #: JTCS-007
• Status: Recruiting
• Phase: Phase 2
• First received: August 6, 2015
• Last updated: November 1, 2016
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: Juventas Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Major Inclusion Criteria:

• Age =18

• 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.

• Post revascularization intervention inclusion criteria include an attempt at open bypass grafting or endovascular intervention of a popliteal/infrapopliteal lesion(s) on the same leg that has tissue loss without significant improvement in TBI post intervention. The following will be accepted as demonstrating a lack of post intervention toe brachial index (TBI) improvement:

• 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

Major Exclusion Criteria:

• Previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment.

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Biological:
• JVS-100
Biological/Vaccine: JVS-100 Intramuscular Injection
• Placebo
Biological/Vaccine: Placebo Intramuscular Injection

Locations

Country	Name	City	State
United States	Summa Health	Akron	Ohio
United States	Cardiovascular Associates of the Southeast	Birmingham	Alabama
United States	UNC	Chapel Hill	North Carolina
United States	Northwestern	Chicago	Illinois
United States	RUMC	Chicago	Illinois
United States	Morton Plant Hosptial - Baycare	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Metro Health	Cleveland	Ohio
United States	University Hospitals	Cleveland	Ohio
United States	UC Davis	Davis	California
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	St. Luke's Mid America Heart Institute	Kansas City	Missouri
United States	Cedars-Sinai Heart Institute	Los Angeles	California
United States	Mount Sinai Medical Center	Miami	Florida
United States	Medical College of Wisconsin	Milwauke	Wisconsin
United States	Lifespan Health System	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	VCU	Richmond	Virginia
United States	Mayo	Rochester	Minnesota
United States	St. Joseph's Hospital	Tampa	Florida
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Cardiology Associates Research	Tupelo	Mississippi
United States	MedStar Georgetown UH	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Juventas Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome.	Change from baseline in the composite endpoint at 3 months in all treated (or one JVS-100 dose group) compared to all placebo.	3 months	No
Primary	The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome.	Change from baseline in the composite endpoint at 6 months in all treated (or one JVS-100 dose group) compared to all placebo.	6 months	No