[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"JSC NextGen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,65],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100628296","phase-2-the-study-is-being-conducted-to-find-a-new-treatment-for-patients-suffering-from-interstitial-cystitis-with-hunners-lesions-100628296",false,"NCT07459790","The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner's Lesions","Double-blind, Placebo-controlled, Adaptive, Multicenter, Prospective, Randomized, Comparative, Parallel-group Study of the Efficacy and Safety of Neovasculgen (Plasmid Supercoiled Deoxyribonucleic Acid pCMV-VEGF165) in Painful Bladder Syndrome\u002FInterstitial Cystitis (BPS\u002FIC) With Hunner's Lesions","Inclusion Criteria:\n\n1. Written informed consent prior to any study-related procedures.\n2. Women aged 18 to 65 years, inclusive.\n3. A confirmed diagnosis of painful bladder syndrome\u002Finterstitial cystitis, characterized by pelvic pain associated with filling or emptying the bladder, frequent urination day and night, with symptoms lasting at least 12 months, with the exclusion of a urinary tract infection or other disease that could cause such symptoms.\n4. The presence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).\n5. A glycated hemoglobin level within the normal range for the patient's age group.\n6. Ability to comply with all study requirements, in the opinion of the investigator, including regularly keeping a voiding diary, completing questionnaires, and attending all scheduled study visits.\n7. Women who are of childbearing potential must have negative pregnancy test results and must use reliable contraception throughout their participation in the study.\n\nExclusion Criteria:\n\n1. Any condition that prevents intravesical administration of medications.\n2. Received medication or non-medication therapy, including physical therapy, for BPS\u002FIC within 1 month prior to study inclusion.\n3. Instillation of any pharmacological agent into the bladder less than 1 month prior to screening.\n4. History of chronic drug or alcohol abuse.\n5. Pregnant women, planning to become pregnant during the study, or currently breastfeeding.\n6. Any other conditions associated with pelvic pain, except for PBS.\n7. Pelvic surgery less than 6 months prior to the study.\n8. Any intravesical procedures, except for diagnostic cystoscopy, less than 3 months prior to screening.\n9. History of allergy or intolerance to the anesthetic or antibiotics that the investigator intends to use during the study.\n10. Inability to discontinue anticoagulant\u002Fantiplatelet medications at least 5 days prior to each investigational drug administration and resume them on the 4th day after each investigational drug administration (low molecular weight heparin may be used for 3 days after investigational drug administration).\n11. Diseases of the urinary tract\u002Fbladder (neoplasms, tuberculous and bacterial cystitis, urolithiasis, radiation injury, urethral diverticulum, neurogenic dysfunction of the lower urinary tract) and female genital organs (neoplasms, vaginitis, genital infections).\n12. Other conditions that, in the opinion of the research physician, could become an objective obstacle to the patient's participation in the study and\u002For create additional risks for the patient.\n13. A history of intravesical botulinum therapy performed within the last 12 months prior to inclusion in this study.\n14. Bladder capacity under anesthesia less than 150 ml.\n15. Residual urine volume greater than 50 ml.","FEMALE","18 Years","65 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis with Hunner's lesions to reduce cicatricial changes in the bladder caused by electrocoagulation and to prevent secondary bladder shrinkage with a decrease in its volume.",[28,29,30],"IC","Hunner Type Interstitial Cystitis","Bladder Pain Syndrome","RECRUITING","2026-03-09",{"date":34,"type":35},"2026-03-10","ACTUAL",{"date":37,"type":35},"2023-12-29",{"date":39,"type":21},"2027-10-30",{"name":41,"class":42},"JSC NextGen","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100623028","phase-2-the-study-is-being-conducted-to-find-a-new-treatment-for-patients-suffering-from-interstitial-cystitis-without-hunners-lesions-100623028","NCT07391306","The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner's Lesions.","Double-blind, Placebo-controlled, Adaptive, Multicenter, Prospective, Randomized, Comparative, Parallel-group Study of the Efficacy and Safety of Neovasculgen (Plasmid Supercoiled Deoxyribonucleic Acid pCMV-VEGF165) in Painful Bladder Syndrome\u002FInterstitial Cystitis (BPS\u002FIC)","Inclusion Criteria:\n\n1. Written informed consent prior to any study-related procedures.\n2. Women aged 18 to 65 years, inclusive.\n3. A confirmed diagnosis of painful bladder syndrome\u002Finterstitial cystitis, characterized by pelvic pain associated with filling or emptying the bladder, frequent urination day and night, with symptoms lasting at least 12 months, with the exclusion of a urinary tract infection or other disease that could cause such symptoms.\n4. Absence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).\n5. A glycated hemoglobin level within the normal range for the patient's age group.\n6. Ability to comply with all study requirements, at the discretion of the investigator, including regularly keeping a voiding diary, completing questionnaires, and attending all scheduled study visits.\n7. Women who are of childbearing potential must have negative pregnancy test results and must use reliable contraception throughout their participation in the study.\n\nExclusion Criteria:\n\n1. Any condition that prevents intravesical administration of medications.\n2. Received medication or non-medication therapy, including physical therapy, for BPS\u002FIC within 1 month prior to study inclusion.\n3. Instillation of any pharmacological agent into the bladder less than 1 month prior to screening.\n4. History of chronic drug or alcohol abuse.\n5. Pregnant women, planning to become pregnant during the study, or currently breastfeeding.\n6. Any other conditions associated with pelvic pain, except for BPS\n7. Pelvic surgery less than 6 months prior to the study\n8. Any intravesical procedures, except for diagnostic cystoscopy, less than 3 months prior to screening\n9. History of allergy or intolerance to the anesthetic or antibiotics that the investigator intends to use during the study.\n10. Inability to discontinue anticoagulant\u002Fantiplatelet medications at least 5 days prior to each investigational drug administration and resume them on the 4th day after each investigational drug administration (low molecular weight heparin may be used for 3 days after investigational drug administration).\n11. Diseases of the urinary tract\u002Fbladder (neoplasms, tuberculous and bacterial cystitis, urolithiasis, radiation injury, urethral diverticulum, neurogenic dysfunction of the lower urinary tract) and female genital organs (neoplasms, vaginitis, genital infections).\n12. Other conditions that, in the opinion of the research physician, could become an objective obstacle to the patient's participation in the study and\u002For create additional risks for the patient.\n13. A history of intravesical botulinum therapy performed within the last 12 months prior to inclusion in this study.\n14. Bladder capacity under anesthesia less than 150 ml.\n15. Residual urine volume greater than 50 ml.",{"count":20,"type":21},[24,25],"To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis and the prevention of secondary bladder shrinkage with a decrease in its volume.",[28,55,56],"Interstitial Cystitis and Bladder Pain Syndrome","Interstitial Cystitis, Chronic","2026-01-29",{"date":59,"type":35},"2026-02-05",{"date":61,"type":35},"2024-02-16",{"date":63,"type":21},"2027-05-31",{"name":41,"class":42},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":43},"100623029","phase-3-the-prospective-double-blind-multicenter-placebo-controlled-randomized-comparative-clinical-trial-100623029","NCT07391319","The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial","\"Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Study of the Efficacy and Safety of the Drug Neovasculgen® Lyophilisate for the Preparation of a Solution for Intramuscular Administration 1.2 mg\", Manufacturer Federal State Budgetary Institution \"NMITs of Hematology\" of the Ministry of Health of the Russian Federation, Russia in Patients With Diabetic Foot Syndrome\"","Inclusion Criteria:\n\n1. Male and female patients aged 18 years and above inclusive (at the time of study entry) with neuroischemic form of diabetic foot syndrome.\n2. Type 1 or type 2 diabetes mellitus.\n3. Prolonged non-healing ulcerative defect on the background of standard therapy (at least 1 month), limited to the foot.\n4. Depth of ulcer defect according to Wagner Scale- 1 or 2 degrees.\n5. Oxygen tension in the tissues directly adjacent to the ulcer defect area, from 20 to 45 mm Hg.\n6. Patients with no urgent indications for limb amputation.\n7. Acceptable ankle- brachial index range of 1.3-0.25.\n8. Patient's willingness to comply with the requirements for examination and treatment.\n9. Availability of written informed consent from the patient.\n10. Patient's consent to follow the regimen of unloading the affected area throughout the study (for patients with plantar ulcer location)\n\nExclusion Criteria:\n\n1. Age under 18.\n2. Chronic ischemia of the lower limbs of non-atherosclerotic (other than diabetes mellitus) origin: vasculitis, systemic connective tissue diseases, Buerger's disease, congenital anomalies and vascular injuries, embolism.\n3. Calcaneal localization of the ulcer.\n4. Neuropathic form of diabetic foot syndrome.\n5. Severe neuroosteoarthropathic deformity of the foot or other deformity that has a significant impact on the healing process.\n6. Ischemia, threatening limb loss.\n7. Presence of clinical signs of an infectious process in the ulcer area that is not controlled by the ongoing antibacterial therapy.\n8. Presence of purulent-destructive lesions of the foot (abscess, phlegmon, osteomyelitis, etc.).\n9. Skin changes associated with venous pathology.\n10. Proliferative and terminal stages of diabetic retinopathy.\n11. The level of glycated hemoglobin at the entrance to the study is more than 11%.\n12. Diabetic ketoacidosis or diabetic precoma.\n13. Systemic use of glucocorticosteroids and\u002For other immunosuppressive drugs within the last 30 days before inclusion in the study.\n14. Recent (less than 1 month) surgery or endovascular intervention on the arteries of the lower extremities or recent (less than 1 month) deep vein thrombosis of the lower extremities.\n15. Recent (less than 3 months) cases of acute myocardial infarction, unstable angina, coronary artery bypass grafting or stenting of the coronary arteries, stroke or transient ischemic attacks.\n16. Planned major surgery in the next 6 months.\n17. Severe concomitant disease with life expectancy less than one year.\n18. Infectious diseases, septic conditions, HIV infection.\n19. Diagnosis of cancer within the last 5 years.\n20. Pregnancy, breastfeeding period.\n21. Positive pregnancy test in women of reproductive age.\n22. Alcohol or drug addiction.\n23. Any other disease (including mental) or clinical condition that, in the opinion of the researcher, may affect the patient's ability to participate in the study.","ALL",{"count":74,"type":21},144,[25],"The main objective of the study is to evaluate the efficacy and safety of Neovasculgen® in a course dose of 2.4 mg in combination with standard drug therapy in patients with unilateral neuroischemic form of diabetic foot syndrome.",[78,79],"Ulcer Foot","Mellitus Diabetes",{"date":59,"type":35},{"date":82,"type":35},"2025-02-11",{"date":84,"type":21},"2027-03-31",{"name":41,"class":42},""]