[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Venturis Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100089548","phase-1-fgf-1-for-intramuscular-injection-for-the-treatment-of-peripheral-arterial-disease-100089548",false,"NCT00424866","FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease","A Phase 1, Open Label, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Peripheral Arterial Disease Patients With Intermittent Claudication","Inclusion Criteria\n\n1. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.\n2. Age must be ≥50 and ≤75 years of age with a life expectancy of \\> 1 year and leg survival \\> 6 months. Patients \\>75 and ≤80 years of age will be considered if they show no signs of cognitive or muscle function decline and are fully able to comply with the protocol.\n3. Patients must have experienced intermittent claudication for at least 6 months and have been stable for the past 3 months.\n4. Patients must have peripheral arterial disease, as confirmed by a resting ABI ≥0.40 and \\\u003C0.90 based on at least one leg as measured using both the dorsal pedis and posterior tibial arteries.\n5. Stenosis of \\>70% up to total occlusion must be present in the popliteal artery and\u002For in the tibial peroneal trunk or at least 2 tibial arteries above the ankle without inflow limitation of the popliteal artery. Adequate popliteal inflow is defined as continuous flow from the abdominal aorta, iliac, common femoral and superficial femoral with any stenosis \\\u003C 50% as determined either by intra-arterial DSA, CTA or Gd CE-MRA.\n6. The screening Gardner treadmill test peak walking times (PWT) must be \\>1 minute and \\\u003C 12 minutes and limited by pain in one or both calves.\n7. Preexisting medication regime must be stable for 6 weeks preceding dosing.\n\nExclusion Criteria\n\n1. Evidence of critical leg ischemia, i.e. ischemic rest pain or ischemic ulceration\n2. Treadmill walking limited by conditions other than intermittent claudication including arthritis, angina and dyspnea\n3. Lower limb amputation of, or in, either leg including toes\n4. Evidence of limb ischemia from immunologic or inflammatory disorders\n5. Leg surgery or revascularization within past 6 months or peripheral angioplasty within past 3 months or anticipated during study\n6. Participation in any investigational device or drug trial within the past 6 months\n7. Myocardial infarction, unstable angina, stroke or ischemic attack within past 6 months\n8. New York Heart Association (NYHA) class II, III or IV heart failure, restrictive or hypertrophic cardiomyopathy or severe valvular disease\n9. QTc elongation greater than 450 ms in males or 460 ms in females\n10. PT (INR), PTT, urinalysis, thyroid function (T3, T4, TSH) outside normal limits\n11. Hemorrhage or thrombotic events (e.g. deep vein thrombosis) within past 6 months\n12. Thrombocytopenia (\\\u003C100,000\u002Fµl), history of heparin-induced thrombocytopenia\n13. Major surgery with the past 6 months\n14. Positive proliferative retinopathy exam\n15. Present of any type of cancer or history of cancer except past (but not present) basal cell dermal carcinoma not on either leg\n16. Inflammatory or progressive fibrotic or myelofibrotic disorders\n17. Patients experiencing bacterial or viral infection (e.g. hepatitis or HIV) or who may otherwise be febrile\n18. Hemoglobin A1c(HgbA1c) of \\>8%\n19. Type I diabetes\n20. Total fasting cholesterol \\>200\n21. Uncontrolled hypertension (≥160 systolic or ≥100 diastolic pressure) or hypotension (\\\u003C90 systolic or \\\u003C60 diastolic pressure)\n22. Disease or drug (e.g. systemic corticosteroid) immuno-compromised\n23. Hepatic dysfunction as defined either by AST or ALT \\> 2.0 times the upper limit of normal\n24. Serum creatinine of ≥ 2.5 mg\u002Fdl\n25. Proteinuria (urine protein\u002Fcreatinine ratio \\> 3)\n26. Antiproliferative drugs (e.g. thalidomide, hydroxyurea)\n27. Radiation therapy\n28. Implanted devices not compatible with strong magnetic fields\n29. Life expectance of less than 1 year\n30. Females who are premenopausal and not sterilized or using adequate birth control or are either pregnant, intend to become pregnant or are nursing","ALL","50 Years","75 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.",[28,29,30],"Peripheral Arterial Disease","Stenosis","Intermittent Claudication",[28,32,30],"Ischemia","NOT_YET_RECRUITING","2026-08-17",{"date":36,"type":37},"2026-08-19","ACTUAL",{"date":39,"type":21},"2028-10-15",{"date":41,"type":21},"2030-12-15",{"name":43,"class":44},"Venturis Therapeutics, Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100066549","phase-2-fibroblast-growth-factor-1-fgf-1-for-the-treatment-of-coronary-heart-disease-100066549","NCT00117936","Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease","Human Recombinant Fibroblast Growth Factor-1 (FGF-1), for the Treatment of Subjects With Severe Coronary Heart Disease, a Placebo Controlled, Double-blind, Dose-varying Study","Inclusion criteria\n\n1. Sign an informed consent form.\n2. Age ≥25 and ≤75 years, either gender, and any race.\n3. At least a 3 month history of chronic, stable angina and is relieved by rest and\u002For nitroglycerin.\n4. Documented symptomatic CCS Angina Classification of III to IV despite use of optimal medical therapy as noted in Inclusion Criterion 10.\n5. Pattern of CHD (coronary pathology) where percutaneous interventional therapy and\u002For CABG is not recommended by the treating cardiologist. This decision should have a documented basis in either complicated vessel physiology and\u002For lack of suitable target vessels for both PTCA and CABG, or past history of complications.\n6. One\u002Ftwo\u002Fthree vessel disease as evidenced either by an angiographic documentation of advanced atherosclerotic narrowing of ≥60% of at least one major epicardial coronary artery (right coronary artery \\[RCA\\], left circumflex \\[LCX\\], or LAD \\[or any of their branches\\]), or of diffuse type of CHD as evidenced by the appearance on coronary angiography of multiple stenoses, multiple atherosclerotic plaques, and\u002For peripheral occlusion(s) of coronary vessel(s) with and without a history of MIs.\n7. demonstrate a radionuclide or angiographically determined left ventricular ejection fraction (LVEF) ≥30%.\n8. Pre-operative proof of reversible ischemia.\n9. No evidence of proliferative retinopathy or significant non-proliferative retinopathy.\n10. must be on optimal medical therapy for at least 2 months prior to entering the study, as documented by a medical history. This will include medical management, and subjects must enter the study on at least one of the following medications: beta-blockers, calcium entry blockers, ranolizine, or long-acting nitrates.\n11. Exercise duration during the qualifying treadmill tests at Visit 1 and Visit 2 is ≥3 and ≤9 minutes on a modified Bruce protocol.\n12. Exercise durations for the qualifying treadmill tests at Visits 1 and 2 must satisfy at least one of the two following conditions: (a) they differ by less than or equal to 20% of the longer time; (b) they differ by less than or equal to 60 seconds. Subjects whose ETTs at Visits 1 and 2 do not satisfy at least one of these two conditions are allowed a third ETT, at the investigator's discretion, from 5 to 7 days after Visit 2. If a third ETT is done, then when compared with the second ETT it must satisfy at least one of the two conditions above.\n13. For a treadmill test result to support inclusion it must terminate in the presence of angina for either of the following reasons: (a) angina becomes too severe to continue the test AND there must be a horizontal depression or downsloping ST-segment of at least 1 mm measured 80 ms from the J point as subsequently established by the Biomedical Systems central ECG lab, or (b) angina of any grade AND there must be a horizontal depression or downsloping ST-segment measured 80 ms from the J point of 2 mm during exercise. The qualifying time for the treadmill test will then be the time to a horizontal depression or downsloping ST-segment of 1 mm compared to the pre-exercise ST segment as subsequently established by the Biomedical Systems central ECG lab.\n14. A forced vital capacity (FVC) of ≥30%.\n15. A negative pregnancy test in women of childbearing potential at Screening.\n16. Female subjects must be post-menopausal or sterilized, or if she is of childbearing potential, she is not breast feeding, has no intention to become pregnant during the course of the study, and is using contraceptive drugs or devices.\n17. Negative cancer screening tests according to the American Cancer Society (\\[ACS\\] Appendix 13.8).\n18. Ability to complete the study in compliance with the protocol.\n\nExclusion criteria\n\n1. History of undergoing a CABG, PTCA or TMR or evidence of an acute MI in the last 3 months.\n2. Subjects with malignancies or a history of malignancies (with the exception of basal cell carcinoma \\[BCC\\] of the skin) will be excluded from the study. Those subjects with a history of BCC are eligible for enrollment, and will be monitored by a qualified dermatologist every 8 weeks for a period of 6 months for evaluation of their skin condition. Subjects with existing BCC will be excluded from the study.\n3. Evidence of concurrent clinically significant infection (e.g. elevated white blood cell \\[WBC\\] count \\>13,000 x 109\u002FL, temperature \\>38.5°C), evidence of \"common cold\" or \"flu.\"\n4. Concomitant other structural heart disease, such as moderate to severe heart valve disease, congenital heart disease, etc. other than evidence of congestive heart failure that is directly related to past ischemic events.\n5. Left ventricular thrombus (mobile or mural-based) as evidenced by ventriculogram or echocardiography.\n6. Creatine kinase (CK) levels \\>3 x upper limit of normal (ULN).\n7. Renal insufficiency requiring dialysis or laboratory evidence of a serum creatinine \\>2.0 mg\u002FdL.\n8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2 x ULN.\n9. History of coagulation disorders or abnormal prothrombin time (PT) or partial thromboplastin time (PTT) \\>1.5 x ULN, thrombocytopenia (\\\u003C100,000\u002Fµl), or ongoing anticoagulant therapy (with the exception of aspirin, up to 85 mg\u002Fday).\n10. History of blood cell diseases.\n11. Poorly controlled insulin-dependent diabetes mellitus (HbA1c \\>8%)\n12. Pre-existing retinal disease, including proliferative retinopathy, severe nonproliferative retinopathy.\n13. Use of any illicit recreational drugs within the past year.\n14. A positive test result for human immunodeficiency virus (HIV) antibody.\n15. Screening ECG results demonstrating recent evidence of transmural ischemia.\n16. Clinically significant ECG abnormalities, e.g.: QRS duration \\>0.12 seconds; QTc \\>450 ms in males or \\>460 ms in females;High-grade trioventricular (AV) block; Left bundle branch block(LBBB; Left ventricular hypertrophy(LVH) with secondary ST-T changes; Frequent, recurrent, or sustained ventricular arrhythmia; Resting ST segment depression \\>1 mm (measured 80 ms beyond the J point) at baseline.\n17. Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years.\n18. Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent and comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the trial.\n19. Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving IMP.\n20. Any subject with unstable angina.\n21. Heart failure New York Heart Association (NYHA) Functional Class III or IV.\n22. Uncontrolled hypertension precluding exercise testing and\u002For contributing to angina severity (systolic blood pressure \\[SBP\\] \\>200 mmHg or diastolic blood pressure \\[DBP\\] \\>110 mmHg), or significant hypotension (SBP \\\u003C90 mmHg or DBP \\\u003C60 mmHg).\n23. Subjects currently on External Counter Pulsation therapy or who have received this therapy within 3 months prior to the screening date.\n24. Any mobility or pulmonary complication that impedes the subject's ability to perform an exercise stress test.\n25. Total fasting serum cholesterol \\>200 mg\u002FdL (if levels greater than or equal to 200 mg\u002FdL, additional medical interventions can be initiated to bring levels below 200 mg\u002FdL).\n26. History of heparin-induced thrombocytopenia.\n27. Subjects with a history of recurrent symptomatic atrial fibrillation or significant ventricular arrhythmias.\n28. Aortic or mitral valve replacement.\n29. Subjects who have undergone heart transplantation.\n30. Medical history and physical examination displaying any evidence that catheterization is contraindicated.","25 Years",{"count":55,"type":21},150,[25],"Treatment for no-option heart patients with coronary artery disease. Procedure includes the injection into the heart of a protein growth factor, administered by the Biological Delivery Systems MyoStar injection and mapping catheters, to stimulate the growth of blood vessels around blocked coronary arteries.",[59,60,61,62],"Coronary Disease","Coronary Heart Disease","Myocardial Ischemia","Coronary Arteriosclerosis",[64,65,66,67,68,69],"Angiogenesis","No-option heart patients","Blocked coronary artery","Revascularization","FGF-1","growth factor",{"date":36,"type":37},{"date":72,"type":21},"2027-09-01",{"date":74,"type":21},"2030-06-15",{"name":43,"class":44},""]