Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-02-21 @ 1:55 AM
Study NCT ID:
NCT02544204
Status:
UNKNOWN
Last Update Posted:
2016-11-02
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '3 months', 'description': 'Change from baseline in the composite endpoint at 3 months in all treated (or one JVS-100 dose group) compared to all placebo.'}, {'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.', 'timeFrame': '6 months', 'description': 'Change from baseline in the composite endpoint at 6 months in all treated (or one JVS-100 dose group) compared to all placebo.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '32419594', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30786835', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n* Age ≥18\n* 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.\n* 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.\n* 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:\n\n * TBI ≤ 0.51or;\n * Toe pressure ≤50 mmHg with flat or dampened wave forms or;\n * Skin Perfusion pressure ≤40 mmHg at mid foot level or;\n * TcPO2 ≤40 mmHg\n* 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\n\nMajor Exclusion Criteria:\n\n* Previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment.\n* 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\n* Staged or planned intervention in the index leg within 30 days after the index procedure\n* Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease\n* Non-salvageable limb defined as major tissue loss and an unsalvageable foot;\n* Wounds that have decreased in size by \\>50% between the Screening visit and Day 0.\n* 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.\n* Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition.\n* Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial'}, 'identificationModule': {'nctId': 'NCT02544204', 'acronym': 'STOP-PAD', 'briefTitle': 'SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Juventas Therapeutics, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'JTCS-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '8 mg JVS-100', 'description': 'Biological/Vaccine: JVS-100 Injection Intramuscular Injection', 'interventionNames': ['Biological: JVS-100']}, {'type': 'PLACEBO_COMPARATOR', 'label': '8 mg placebo', 'description': 'Biological/Vaccine: Placebo Injection Intramuscular Injection', 'interventionNames': ['Biological: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '16 mg JVS-100', 'description': 'Biological/Vaccine: JVS-100 Injection Intramuscular Injection', 'interventionNames': ['Biological: JVS-100']}, {'type': 'PLACEBO_COMPARATOR', 'label': '16 mg placebo', 'description': 'Biological/Vaccine: Placebo Injection Intramuscular Injection', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'JVS-100', 'type': 'BIOLOGICAL', 'description': 'Biological/Vaccine: JVS-100 Intramuscular Injection', 'armGroupLabels': ['16 mg JVS-100', '8 mg JVS-100']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Biological/Vaccine: Placebo Intramuscular Injection', 'armGroupLabels': ['16 mg placebo', '8 mg placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chris Huff, MD', 'role': 'CONTACT', 'phone': '205-795-5193'}], 'facility': 'Cardiovascular Associates of the Southeast', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Davis', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Laird, MD', 'role': 'CONTACT', 'phone': '916-734-4156'}], 'facility': 'UC Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tim Henry, MD', 'role': 'CONTACT', 'phone': '310-423-1231'}], 'facility': 'Cedars-Sinai Heart Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Kim, MD', 'role': 'CONTACT', 'phone': '202-444-0793'}], 'facility': 'MedStar Georgetown UH', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Clearwater', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Les Miller, MD', 'role': 'CONTACT', 'phone': '727-489-2543'}], 'facility': 'Morton Plant Hosptial - Baycare', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nirat Beohar, MD', 'role': 'CONTACT', 'phone': '305-674-2121', 'phoneExt': '56022'}], 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sai Sadanandan, MD', 'role': 'CONTACT', 'phone': '813-875-9000'}], 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Ho, MD', 'role': 'CONTACT', 'phone': '513-585-1777'}], 'facility': 'Northwestern', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeff Snell, MD', 'role': 'CONTACT', 'phone': '312-942-8707'}], 'facility': 'RUMC', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Houma', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Craig Walker, MD', 'role': 'CONTACT', 'phone': '985-873-5613'}], 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tom Davis, MD', 'role': 'CONTACT', 'phone': '313-343-4714'}], 'facility': 'St. John Hospital and Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sanjay Misra, MD', 'role': 'CONTACT', 'phone': '507-538-6419'}], 'facility': 'Mayo', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Tupelo', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Murray Estess, MD', 'role': 'CONTACT', 'phone': '662-377-5447'}], 'facility': 'Cardiology Associates Research', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matt Bunte, MD', 'role': 'CONTACT', 'phone': '816-932-4948'}], 'facility': "St. Luke's Mid America Heart Institute", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Teaneck', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Runback, MD', 'role': 'CONTACT', 'phone': '201-530-7968'}], 'facility': 'Holy Name Medical Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Marston, MD', 'role': 'CONTACT', 'phone': '919-843-1268'}], 'facility': 'UNC', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Raleigh', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matt Hook, MD', 'role': 'CONTACT', 'phone': '919-740-4897'}], 'facility': 'NC Heart and Vascular Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Akron', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justin Dunn, MD', 'role': 'CONTACT', 'phone': '330-253-8195', 'phoneExt': '4259'}], 'facility': 'Summa Health', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mehdi Shishehbor, DO', 'role': 'CONTACT', 'phone': '216-444-0922'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sanjay Gandhi, MD', 'role': 'CONTACT', 'phone': '216-778-2714'}], 'facility': 'Metro Health', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vikram Kashyap, MD', 'role': 'CONTACT', 'phone': '216-983-4719'}], 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter Soukas, MD', 'role': 'CONTACT', 'phone': '401-793-4105'}], 'facility': 'Lifespan Health System', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luis Guzman, MD', 'role': 'CONTACT', 'phone': '804-628-2452'}], 'facility': 'VCU', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Milwauke', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Gossett, MD', 'role': 'CONTACT', 'phone': '414-955-6749'}], 'facility': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juventas Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}