[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562618":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":36,"locations":45,"responsibleParty":62,"collaborators":10,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Jumeirah American Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intracavernosal Injection of Autologous Adipose Stem Cells for Erectile Dysfunction Treatment",null,"In this arm of the study, participants will receive intracavernosal injections of autologous adipose tissue-derived stem cells (ADSC). The ADSC are collected from the participant's own body fat through a minimally invasive liposuction procedure. After processing, the stem cells will be injected directly into the erectile tissue of the penis. This treatment aims to improve erectile function by stimulating tissue regeneration and enhancing blood flow. Participants will be monitored for safety and efficacy, including erectile function assessments using the International Index of Erectile Function (IIEF) and penile hemodynamics measured by Doppler ultrasound. Follow-up evaluations will occur at 3, 6, 9, and 12 months post-treatment.",[13],"Procedure: Autologous Adipose Tissue-Derived Stem Cell Injection for Erectile Dysfunction",{"label":15,"type":10,"description":16,"interventionNames":17},"Intracavernosal Injection of Stem cell-derived exosomes","In this arm of the study, participants will receive intracavernosal injections of stem cell-derived exosomes. These exosomes, which are nano-sized extracellular vesicles obtained from cultured stem cells, are rich in growth factors and bioactive molecules that facilitate tissue repair and regeneration. Unlike stem cell therapy, this cell-free approach minimizes potential risks associated with live cell transplantation while still delivering therapeutic benefits. Participants will be monitored for safety and efficacy, including erectile function assessments using the International Index of Erectile Function (IIEF) and penile hemodynamics measured by Doppler ultrasound. Follow-up evaluations will occur at 3, 6, 9, and 12 months post-treatment.",[18],"Procedure: Stem cell-derived Exosomes Injection for Erectile Dysfunction",[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Autologous Adipose Tissue-Derived Stem Cell Injection for Erectile Dysfunction","This intervention involves the use of autologous adipose tissue-derived stem cells (ADSC) to treat erectile dysfunction. The process begins with a minimally invasive liposuction procedure to harvest fat tissue from the participant\\'s own body. The harvested fat is then processed to isolate stem cells, which are subsequently injected directly into the erectile tissue of the penis. This approach aims to enhance erectile function by promoting tissue regeneration and improving blood flow. Unlike other treatments for erectile dysfunction, this intervention uses stem cells derived from the participant\\'s own fat, which may reduce the risk of immune rejection and offer a novel regenerative therapy option. The treatment is designed to address ED in patients who have not responded adequately to conventional therapies like PDE-5 inhibitors.",[9],[26,27,28],"ADSC Injection for ED","Fat-Derived Stem Cell Therapy for Erectile Dysfunction","Autologous Fat Stem Cell Injection",{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Stem cell-derived Exosomes Injection for Erectile Dysfunction","This intervention involves the use of stem cell-derived exosomes to treat erectile dysfunction. Exosomes are nano-sized extracellular vesicles secreted by stem cells, containing bioactive molecules such as growth factors and signaling proteins that promote tissue repair and regeneration. Unlike therapies requiring the transplantation of live cells, this cell-free approach eliminates the need for invasive harvesting procedures. The exosomes are carefully purified from cultured stem cells and prepared for direct injection into the erectile tissue of the penis. This approach aims to enhance erectile function by stimulating tissue regeneration, reducing inflammation, and improving blood flow. Unlike other treatments for erectile dysfunction, exosome therapy offers a novel regenerative option, potentially benefiting patients who have not responded adequately to conventional therapies such as PDE-5 inhibitors.",[15],[34,35],"Extracellular Vesicle Therapy","Cell-Free Regenerative Therapy for ED",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Ranjith Ramasamy, MD","CONTACT","+971 800 522823","ranjith.ramasamy@jac.ae",{"name":43,"role":39,"phone":10,"phoneExt":10,"email":44},"Jessie Bagolor, RN","jessie.bagolor@jac.ae",[46],{"facility":5,"status":47,"city":48,"state":48,"zip":10,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Dubai","United Arab Emirates","AE",{"type":52,"coordinates":53},"Point",[54,55],55.30927,25.07725,{"lat":55,"lon":54},[58,59],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},{"name":60,"role":39,"phone":61,"phoneExt":10,"email":44},"Jessie Magoncia Bagolor, RN","+971 50 869 8497",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Ranjith Ramasamy","Consultant Urologist","100562618","regenerative-injection-of-stem-cells-or-stem-cell-derived-exosomes-for-erectile-dysfunction-rise-100562618",false,"NCT06605508","Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE)","Prospective Observational Study on Intracavernosal Injection of Autologous Adipose Tissue-Derived Stem Cells (ADSC) or Stem Cell-derived Exosomes for the Treatment of Erectile Dysfunction","RISE","Inclusion Criteria:\n\n* Age: Adult males aged 30 to 75 years.\n* Diagnosis: Confirmed diagnosis of erectile dysfunction (ED) of mild to moderate severity, as defined by an International Index of Erectile Function (IIEF) score.\n* Treatment Response: Failure or suboptimal response to conventional ED treatments, such as PDE-5 inhibitors.\n* General Health: Overall good health without contraindications to stem cell therapy.\n* Informed Consent: Ability and willingness to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Severe Cardiovascular Disease: Presence of severe cardiovascular conditions, including uncontrolled hypertension or significant heart disease.\n* Active Infections: Ongoing infections that could interfere with treatment or pose a risk to the participant.\n* Malignancies: History of or current cancer, including malignancies that could affect safety or treatment outcomes.\n* Contraindications to Stem Cell Therapy: Any medical conditions or treatments that contraindicate the use of stem cell therapy.\n* Uncontrolled Diabetes: Poorly controlled diabetes or other metabolic disorders that could impact treatment efficacy or safety.\n* Psychiatric or Cognitive Impairments: Significant psychiatric or cognitive disorders that may affect the participant\\'s ability to comply with study protocols or provide informed consent.\n* Recent Surgery or Trauma: Recent major surgeries or physical trauma that could impact the study or interfere with the intervention.\n* Participation in Other Studies: Participation in other clinical trials or studies that may affect the outcomes or safety of this study.","MALE","30 Years","75 Years",{"count":78,"type":79},30,"ESTIMATED","OBSERVATIONAL","The goal of this prospective observational study is to evaluate whether injections of stem cells derived from the patient's own fat tissue (adipose tissue) can improve erectile function in men aged 30 to 75 who have erectile dysfunction (ED) and have not responded well to standard treatments like PDE-5 inhibitors (e.g., Viagra).\n\nThe main questions the study aims to answer are:\n\nWill the stem cell injections improve erectile function, as measured by the International Index of Erectile Function (IIEF) score? Are there any changes in blood flow to the penis, which will be measured using a Doppler ultrasound?\n\nParticipants will:\n\nReceive injections of their own stem cells (obtained from a biopsy of fat) directly into the penis.\n\nUndergo assessments to check erectile function before and after treatment. Have follow-up visits at 3, 6, 9, and 12 months to monitor long-term effects. The study will also look for any possible side effects or complications and evaluate biological markers in the penis that may indicate the effectiveness of the treatment.\n\nParticipants will be recruited from clinic where they are already receiving care for ED. To take part, they must be in good overall health, with no severe heart disease, uncontrolled diabetes, cancer, or other conditions that could make stem cell therapy unsafe for them.",[83,84,85],"Erectile Dysfunction","Erectile Dysfunction Associated With Type 2 Diabetes Mellitus","Erectile Dysfunction Following Radical Prostatectomy",[87,88,89,90,91],"stem cell therapy","Erectile dysfunction (ED)","Autologous adipose tissue-derived stem cells (ADSC)","Regenerative medicine for ED","Exosomes","2025-08-25",{"date":94,"type":95},"2025-08-26","ACTUAL",{"date":97,"type":95},"2025-01-10",{"date":99,"type":79},"2029-12-31",{"name":5,"class":6},1]