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Peripheral Arterial DiseasePhase 2STOP-PADNCT02544204

SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease

A Phase 2 study testing JVS-100 in people with Peripheral Arterial Disease, run by Juventas Therapeutics, Inc. at 24 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
JVS-100
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
24 sitesUnited States
Study dates
Nov 2015to Nov 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites, 24 recruiting

  • Summa Health

    Akron, Ohio

    Justin Dunn, MD, 330-253-8195 ext. 4259

    Recruiting

  • Cardiovascular Associates of the Southeast

    Birmingham, Alabama

    Chris Huff, MD, 205-795-5193

    Not yet recruiting

  • UNC

    Chapel Hill, North Carolina

    William Marston, MD, 919-843-1268

    Recruiting

  • Northwestern

    Chicago, Illinois

    Karen Ho, MD, 513-585-1777

    Recruiting

  • RUMC

    Chicago, Illinois

    Jeff Snell, MD, 312-942-8707

    Recruiting

  • Morton Plant Hosptial - Baycare

    Clearwater, Florida

    Les Miller, MD, 727-489-2543

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio

    Mehdi Shishehbor, DO, 216-444-0922

    Recruiting

  • Metro Health

    Cleveland, Ohio

    Sanjay Gandhi, MD, 216-778-2714

    Recruiting

  • University Hospitals

    Cleveland, Ohio

    Vikram Kashyap, MD, 216-983-4719

    Recruiting

  • UC Davis

    Davis, California

    John Laird, MD, 916-734-4156

    Recruiting

  • St. John Hospital and Medical Center

    Detroit, Michigan

    Tom Davis, MD, 313-343-4714

    Recruiting

  • Cardiovascular Institute of the South

    Houma, Louisiana

    Craig Walker, MD, 985-873-5613

    Recruiting

  • St. Luke's Mid America Heart Institute

    Kansas City, Missouri

    Matt Bunte, MD, 816-932-4948

    Recruiting

  • Cedars-Sinai Heart Institute

    Los Angeles, California

    Tim Henry, MD, 310-423-1231

    Recruiting

  • Mount Sinai Medical Center

    Miami, Florida

    Nirat Beohar, MD, 305-674-2121 ext. 56022

    Recruiting

  • Medical College of Wisconsin

    Milwauke, Wisconsin

    James Gossett, MD, 414-955-6749

    Recruiting

  • Lifespan Health System

    Providence, Rhode Island

    Peter Soukas, MD, 401-793-4105

    Recruiting

  • NC Heart and Vascular Research

    Raleigh, North Carolina

    Matt Hook, MD, 919-740-4897

    Recruiting

  • VCU

    Richmond, Virginia

    Luis Guzman, MD, 804-628-2452

    Recruiting

  • Mayo

    Rochester, Minnesota

    Sanjay Misra, MD, 507-538-6419

    Recruiting

  • St. Joseph's Hospital

    Tampa, Florida, 33614

    Sai Sadanandan, MD, 813-875-9000

    Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey

    John Runback, MD, 201-530-7968

    Recruiting

  • Cardiology Associates Research

    Tupelo, Mississippi

    Murray Estess, MD, 662-377-5447

    Recruiting

  • MedStar Georgetown UH

    Washington D.C., District of Columbia

    Paul Kim, MD, 202-444-0793

    Not yet recruiting

Other trials in United States

About this study

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

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.

Being tested
JVS-100, Placebo
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JVS-100Biological

    Biological/Vaccine: JVS-100 Intramuscular Injection

  • PlaceboBiological

    Biological/Vaccine: Placebo Intramuscular Injection

Study groups in NCT02544204
Study groupRoleWhat they receive
8 mg JVS-100Active comparatorBiological/Vaccine: JVS-100 Injection Intramuscular Injection
Receives: Biological: JVS-100
8 mg placeboPlacebo comparatorBiological/Vaccine: Placebo Injection Intramuscular Injection
Receives: Biological: Placebo
16 mg JVS-100Active comparatorBiological/Vaccine: JVS-100 Injection Intramuscular Injection
Receives: Biological: JVS-100
16 mg placeboPlacebo comparatorBiological/Vaccine: Placebo Injection Intramuscular Injection
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionSep 2017 (estimated)
  4. Study completionNov 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02544204
Sponsor's protocol ID
JTCS-007
Acronym
STOP-PAD
Status last verified
Nov 2016
First submitted
6 Aug 2015
Last updated
2 Nov 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32419594

  • 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.

    PubMed 30786835

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JVS-100 in people with Peripheral Arterial Disease, run by Juventas Therapeutics, Inc. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02544204, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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