[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596657":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":55,"centralContacts":55,"locations":56,"responsibleParty":70,"collaborators":55,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":55,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":55,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":55,"overallStatus":95,"whyStopped":55,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"The Methodist Hospital Research Institute","OTHER",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"1: allogeneic adipose-derived mesnchymal stem cells plus saline solution","EXPERIMENTAL","2.00x 10⁸ HB-adMSCCs locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus Placebo via IV in clinic at week 12.",[13,14],"Drug: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR","Drug: Placebo in clinic",{"label":16,"type":10,"description":17,"interventionNames":18},"2: Placebo plus allogeneic adipose-derived mesnchymal stem cells","4 cc of saline solution in the corpora cavernosa of the penis and 4 cc of saline solution along the right and left neurovascular bundles of the penis in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.",[19,20],"Drug: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office","Drug: Placebo in the OR",{"label":22,"type":10,"description":23,"interventionNames":24},"3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinic","2.00x 10⁸ HB-adMSCs locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.",[19,13],{"label":26,"type":27,"description":28,"interventionNames":29},"4: placebo plus placebo","PLACEBO_COMPARATOR","4 cc of saline solution in the corpora cavernosa of the penis and 4 cc of saline solution along the right and left neurovascular bundles of the penis in the OR at week 1 plus saline solutin via IV in clinic at week 12.",[20,14],[31,38,43,49],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office","2.00x10⁸ HB-adMSCs IV at the doctor's office.",[16,22],[37],"HB-adMSCs",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR","100 million stem cells (1.00x10⁸ HB-adMSCs) in the corpora cavernosa of the penis suspended in a 4 cc of sterile saline. 50 million stem cells (5.0x 10⁷ HB-adMSCs) along the right neurovascular bundle and 50 million cell (5.0x 10⁷ HB-adMSCs) along the left neurovascular bundle of the penis suspended in a 4 cc of sterile saline during the surgery",[9,22],[37],{"type":32,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Placebo in the OR","4 cc of saline solution in the corpora cavernosa of the penis and 4 cc of saline solution along the right and left neurovascular bundles of the penis during the surgery .",[16,26],[48],"Saline solution in the OR",{"type":32,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Placebo in clinic","30 mL syringe of the product should be mixed into a 250cc bag of sodium chloride solution 0.9% for infusion. should be administered intravenously, with a dosing rate of 4-5mL\u002Fmin.",[9,26],[54],"Saline solution in clinic",null,[57],{"facility":58,"status":55,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":55},"Houston Methodist","Houston","Texas","77030","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-95.36327,29.76328,{"lat":68,"lon":67},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"PRINCIPAL_INVESTIGATOR","Brian Miles","MD","100596657","phase-1-stem-cells-for-erectile-dysfunction-post-ralp-100596657",false,"NCT07048314","Stem Cells for Erectile Dysfunction Post RALP","A Randomized Clinical Trial to Assess Safety and Efficacy of Allogeneic Adipose-derived Mesenchymal Stem Cells in Promoting the Recovery of Erectile Function Post Radical Retropubic Prostatectomy of Localized Prostate Cancer","Inclusion Criteria:\n\n1. Patients scheduled for RALP with Dr. B. Miles at Houston Methodist.\n2. Men aged between 40 and 70 (inclusive) years old\n3. Localized prostate cancer: Clinical stage T1-T2, N0, M0\n4. Gleason score \\\u003C 7\n5. Pre-op IIEF-5 \\>20 (Appendix A)\n6. Testosterone serum: \\> 300ng\u002Fdl with normal Free Testosterone\n7. Life expectancy of at least 10 years\n8. Performance status of ≤ 2 (Zubrod scale). (Appendix B)\n9. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution\n10. Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery\n11. Supportive partner willing to complete sexual survey questionnaire (Appendix D)\n12. PDE5 inhibitors like sildenafil, tadalafil, vardenafil and avanafil are permitted pre and post-surgery if participant was taking this for ED at least 6 months before surgery.\n13. Patient need cardiac clearance by the cardiologist\n\nExclusion Criteria:\n\n1. Penile anatomical abnormalities (Peyronie's disease)\n2. Hypogonadism\n3. Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.)\n4. Patients with AST levels above 40U\u002FL ; ALT levels above 33 U\u002FL and Glucose levels above 180 mg\u002Fdl and psychiatric disorders that require medication\n5. Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug.\n6. Any previous penile implant or penile vascular surgery\n7. Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery .\n\n   \\-","MALE","40 Years","70 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","This is a phase 1\u002F2 single center, pilot study to assess safety and efficacy of allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) and to evaluate the timing and combination effects of active treatment versus placebo in promoting the recovery of erectile function in patients undergoing radical retropubic prostatectomy (RALP) of localized prostate cancer.",[93,94],"Erectile Dysfunction","Prostate Cancer","NOT_YET_RECRUITING","2026-03-16",{"date":98,"type":99},"2026-03-19","ACTUAL",{"date":101,"type":86},"2026-03-10",{"date":103,"type":86},"2027-06-30",{"name":5,"class":6},1]