[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629860":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":47,"centralContacts":54,"locations":63,"responsibleParty":80,"collaborators":58,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":58,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":58,"studyType":97,"phases":98,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":66,"whyStopped":58,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Ankara City Hospital Bilkent","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Mesenchymal Stem Cell Treatment Group","EXPERIMENTAL","Participants in this group will receive a single intracavernosal injection of umbilical cord-derived mesenchymal stem cells (5×10⁶ cells). The stem cells are produced under Good Manufacturing Practice (GMP) conditions and administered directly into the corpus cavernosum. The treatment aims to improve erectile function by promoting angiogenesis, tissue regeneration, and improved penile vascular function. Participants will be followed for safety and efficacy outcomes during scheduled follow-up visits.",[13],"Biological: Umbilical Cord-Derived Mesenchymal Stem Cells",{"label":15,"type":10,"description":16,"interventionNames":17},"Exosome Treatment Group","Participants in this group will receive a single intracavernosal injection of umbilical cord-derived mesenchymal stem cell-derived exosomes (75 μg). Exosomes are extracellular vesicles that contain growth factors and signaling molecules that may promote tissue repair and vascular regeneration. This cell-free regenerative therapy aims to improve erectile function in patients with diabetic erectile dysfunction.",[18],"Biological: Umblical Cord-Derived Mesenchymal Stem Cell-Derived Exosomes",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo Control Group","PLACEBO_COMPARATOR","Participants in this group will receive a single intracavernosal injection of sterile normal saline (0.9% sodium chloride solution) as placebo. The placebo injection will be administered using the same procedure as the treatment groups in order to maintain study blinding. Participants will undergo the same follow-up assessments as the other study groups.",[24],"Biological: Placebo Intracavernosal Injection",[26,34,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Umbilical Cord-Derived Mesenchymal Stem Cells","Intracavernosal injection of 5×10⁶ umbilical cord-derived mesenchymal stem cells (MSCs) produced under Good Manufacturing Practice (GMP) conditions. The cells are administered directly into the corpus cavernosum to promote tissue regeneration, angiogenesis, and improvement of erectile function in patients with diabetic erectile dysfunction.",[9],[32,33],"Mesenchymal Stem Cell Therapy","MSC Injection",{"type":27,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Umblical Cord-Derived Mesenchymal Stem Cell-Derived Exosomes","Intracavernosal injection of 75 μg mesenchymal stem cell-derived exosomes obtained from cultured umblical cord-derived mesenchymal stem cells. Exosomes are extracellular vesicles containing bioactive molecules that may stimulate angiogenesis, tissue repair, and vascular regeneration in erectile tissue.",[15],[39],"Exosome Therapy",{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Placebo Intracavernosal Injection","Intracavernosal injection of sterile 0.9% sodium chloride solution administered as placebo. The injection procedure will be identical to the treatment groups to maintain study blinding.",[20],[45,46],"Saline Injection","Placebo Injection",[48,51],{"name":49,"affiliation":5,"role":50},"Samet Senel, MD, Associate Professor","STUDY_CHAIR",{"name":52,"affiliation":5,"role":53},"Erkan Olcucuoglu, MD, Associate Professor","STUDY_DIRECTOR",[55,60],{"name":49,"role":56,"phone":57,"phoneExt":58,"email":59},"CONTACT","+90 537 880 22 85",null,"samet_senel_umt@hotmail.com",{"name":52,"role":56,"phone":61,"phoneExt":58,"email":62},"+90 505 517 04 98","erkan.olcucuoglu@saglik.gov.tr",[64],{"facility":65,"status":66,"city":67,"state":67,"zip":68,"country":69,"countryCode":58,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Ankara Bilkent City Hospital","RECRUITING","Ankara","06800","Turkey (Türkiye)",{"type":71,"coordinates":72},"Point",[73,74],32.85427,39.91987,{"lat":74,"lon":73},[77,78],{"name":49,"role":56,"phone":57,"phoneExt":58,"email":59},{"name":79,"role":56,"phone":61,"phoneExt":58,"email":62},"Erken Olcucuoglu, MD, Associate Professor",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"PRINCIPAL_INVESTIGATOR","Samet Şenel","Associate Professor of Urology","100629860","phase-2-mesenchymal-stem-cell-and-exosome-therapy-for-diabetic-erectile-dysfunction-100629860",false,"NCT07480161","Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction","Safety and Efficiacy of Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction: A Randomized Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n* Male patients aged 25 to 75 years\n* Diagnosis of erectile dysfunction for at least 6 months\n* Type 1 or Type 2 diabetes mellitus for at least 5 years\n* Inadequate response to medical treatment, including phosphodiesterase type-5 (PDE-5) inhibitors and\u002For intracavernosal prostaglandin E1 therapy\n* Candidates for penile prosthesis implantation due to treatment-resistant erectile dysfunction\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Penile anatomical deformities\n* Active infection or skin lesion on the penis\n* Bleeding disorders or coagulation abnormalities\n* Previous penile prosthesis implantation, penile vascular surgery, or pelvic surgery\n* Untreated hypogonadism\n* Unstable cardiovascular disease\n* History of malignancy\n* Autoimmune disease\n* Use of immunosuppressive therapy\n* Presence of systemic or local infection\n* Uncontrolled diabetes mellitus","MALE","25 Years","75 Years",{"count":95,"type":96},90,"ESTIMATED","INTERVENTIONAL",[99,100],"PHASE2","PHASE3","The goal of this prospective randomized controlled clinical study is to evaluate the effectiveness and safety of intracavernosal injections of umbilical cord-derived mesenchymal stem cells (MSCs) and umbilical cord-derived MSC-derived exosomes in men aged 25 to 75 years with diabetic erectile dysfunction (ED) who have not responded adequately to conventional medical treatments such as phosphodiesterase type-5 (PDE-5) inhibitors.\n\nDiabetes mellitus is a major risk factor for erectile dysfunction and is associated with endothelial dysfunction, impaired smooth muscle relaxation, neuropathy, and increased fibrosis within penile tissue. Although many patients respond to standard pharmacological treatments, diabetic patients often demonstrate reduced responsiveness to these therapies. Regenerative medicine approaches, including stem cell therapy and stem cell-derived exosomes, have emerged as potential therapeutic strategies due to their regenerative, angiogenic, neuroprotective, and anti-fibrotic effects.\n\nThe main questions this study aims to answer are:\n\n* Whether intracavernosal administration of mesenchymal stem cells or MSC-derived exosomes improves erectile function, as measured by changes in the International Index of Erectile Function-5 (IIEF-5) and Erectile Hardness Score (EHS).\n* Whether penile hemodynamics improve following treatment, as assessed by penile Doppler ultrasonography parameters including peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI).\n\nParticipants will be randomly assigned to one of three groups:\n\n* Intracavernosal placebo injection\n* Intracavernosal injection of umbilical cord-derived mesenchymal stem cells (5×10⁶ cells)\n* Intracavernosal injection of umbilical cord-derived mesenchymal stem cell-derived exosomes (75 μg) All interventions will be administered as a single intracavernosal injection under controlled clinical conditions.\n\nParticipants will undergo baseline evaluation including medical history, physical examination, erectile function assessment using the IIEF-5 questionnaire, and penile Doppler ultrasonography. Follow-up evaluations will be conducted at 1, 3, 6, and 12 months after treatment to assess changes in erectile function, penile vascular parameters, and treatment-related adverse events.\n\nThe study will also monitor potential side effects such as pain, bruising, hematoma, edema, or other complications related to the intracavernosal injection procedure.\n\nParticipants will be recruited from patients presenting to the urology outpatient clinic with diabetic erectile dysfunction. Eligible participants must have a diagnosis of erectile dysfunction for at least six months, a history of diabetes mellitus for at least five years, and insufficient response to standard medical therapy. Patients with penile anatomical deformities, active infections, malignancy, unstable cardiovascular disease, autoimmune disease, or other contraindications to intracavernosal treatment will be excluded.",[103],"Erectile Dysfunction With Diabetes Mellitus",[105,106,107,39,108,109,110,111],"Diabetic Erectile Dysfunction","Mesenchymal Stem Cells","Stem Cell Therapy","Intracavernosal Injection","Regenerative Medicine","Cell-Based Therapy","Erectile dysfunction","2026-03-14",{"date":114,"type":115},"2026-03-18","ACTUAL",{"date":117,"type":115},"2025-12-29",{"date":119,"type":96},"2028-12-29",{"name":5,"class":6},1]