[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580619":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":31,"collaborators":20,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":20,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":20,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":58,"whyStopped":20,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":20},{"fullName":5,"class":6},"Indonesia University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"pretreatment group: severe eretile dysfunction non responsive Sildenafil with no injection","EXPERIMENTAL","postreatment group: severe eretile dysfunction non responsive Sildenafil with injection",[13],"Combination Product: uc-msc secretome intra cavernous injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","uc-msc secretome intra cavernous injection","UC-MSC secretome was obtained from UC-MSC cultures with 80% confluence in serum-free medium after 24 hours of incubation The VEGF level in the secretome given was 1400 pg\u002Fml.\n\nThe intervention was the administration of 0.5 mL\u002Fsite of secretome injection injected intra-cavernous to all subjects using a 22-gauge needle according to a sterile protocol. The same volume was given at bilateral sites of the penile shaft. The intra-cavernous injection sites were in the right and left dorsolateral regions of the penis. After the intervention, tolerability was assessed by observing and questioning the subjects regarding pain during injection.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Ria Margiana, M.D, PhD","CONTACT","+62 811-1775-515","ria.marrgiana11@gmail.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Tania Graciana, M.D","+6285624458456","taniagraciana@gmail.com",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Ria Margiana","Ria Margiana, MD, M.Biomed, PhD","100580619","phase-1-umbilical-cord-mesenchymal-stem-cell-secretome-in-severe-erectile-dysfunction-non-responsive-to-sildenafil-100580619",false,"NCT06839651","Umbilical Cord Mesenchymal Stem Cell Secretome in Severe Erectile Dysfunction Non-responsive to Sildenafil","Analysis of the Safety and Efficacy of Administering Umbilical Cord Mesenchymal Stem Cell Secretome in Patients with Severe Erectile Dysfunction Non-responsive to Sildenafil","Inclusion Criteria:\n\n* Men aged 40-65 years who undergo treatment at the Andrology Clinic of RSUD Dr. Soetomo.\n* Severe erectile dysfunction caused by organic factors for at least 6 months, based on an IIEF-5 score of 5-7\n* History of undergoing treatment with sildenafil 100 mg for four sessions.\n* Evaluation of IIEF-5 score \\\u003C 22 and not meeting the MCID criteria, defined as an IIEF-5 score increase of less than 4\n* Type II Diabetes Melitus with an HbA1c test result of \\\u003C 7%.\n* Laboratory test results for liver function (SGOT and SGPT) and kidney function (urea and creatinine) are within normal limits.\n* Patients with undergoing treatment with antidepressant.\n\nExclusion Criteria:\n\n* Anatomical abnormalities of the penis that are clinically visible, such as Peyronie's disease, a history of priapism, a history of penile implants, skin irritation, and lesions in the area surrounding the penile skin.\n* Active and significant systemic or local infection.\n* History of bleeding or blood clotting disorder therapy.\n* History of systemic autoimmune disorders and immunosuppressive treatment\n* History of prostate surgery, history of malignancy, or a PSA level \\> 4 ng\u002FmL.\n* Untreated hypogonadism or low serum total testosterone (\\\u003C200 ng\u002FdL).\n* Uncontrolled hypertension or hypotension (systolic blood pressure \\>170 or \\\u003C90 mmHg, and diastolic blood pressure \\>100 or \\\u003C50 mmHg).\n* Unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the last 6 months, and congestive heart failure).","MALE","40 Years","65 Years",{"count":46,"type":47},10,"ESTIMATED","INTERVENTIONAL",[50],"PHASE1","The study is an experimental pre-post-test design involving 10 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection.",[53],"Erectile Dysfunctions",[55,56,57],"Erectile dysfunction","secretome","UC-MSC","NOT_YET_RECRUITING","2025-02-24",{"date":61,"type":62},"2025-02-25","ACTUAL",{"date":64,"type":47},"2025-04-21",{"date":66,"type":47},"2026-04-01",{"name":5,"class":6}]