[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07048314":3,"trial-entities:NCT07048314":109,"trial-summary:NCT07048314":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":59,"secondary_outcomes":71,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":83,"locations":86,"central_contacts":105,"overall_officials":106,"references":107,"see_also_links":108},"NCT07048314","Pro00039638","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","RECRUITING","2027-06-30","2026-07","2026-07-10","2026-07-07","The Methodist Hospital Research Institute","OTHER",true,"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.","This is a prospective, single-center, double blind, four-arm, pilot study to evaluate safety and effectiveness of allogeneic stem cells promoting the recovery of erectile function in patients undergoing radical retropubic prostatectomy (RALP) of localized prostate cancer.\n\nAll participants will be assessed for eligibility Participants will be randomized in a 1:1:1:1 ratio to Arm 1, Arm 2, Arm 3 or Arm 4 using a validated system that automates the random assignment of participant numbers to randomization numbers.\n\nStudy participants will be randomized to receive either:\n\nArm 1 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.\n\nArm 2 Placebo 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.\n\nArm 3 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.\n\nArm 4 Placebo 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.\n\nStudy Medication:\n\n1. Stem cells locally injected in the penis: subjects will receive 1.00x 10⁸ HB-adMSCs injection into the corpora cavernosa of the penis and 5.0x10⁷ HB-adMSCs along the right neurovascular bundle and 5.0x10⁷ HB-adMSCs along the left neurovascular bundle during surgery in the Operating Room (OR)\n2. Stem cells delivered intravenous: Subject will receive 2.00x10⁸ HB-adMSCs IV at the doctor's office.\n\nThe treatment duration will be 2 cycles. Treatment will be administered on Week 1 (in the OR) and on week 12 in the Urology Clinic.\n\nThe study duration will be 24 weeks post-surgery.",[19,20],"Erectile Dysfunction","Prostate Cancer",[],"INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},40,"ESTIMATED",[31,40,46,53],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":38},"DRUG","Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office","2.00x10⁸ HB-adMSCs IV at the doctor's office.",[36,37],"2: Placebo plus allogeneic adipose-derived mesnchymal stem cells","3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinic",[39],"HB-adMSCs",{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"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",[44,37],"1: allogeneic adipose-derived mesnchymal stem cells plus saline solution",[39],{"type":32,"name":47,"description":48,"armGroupLabels":49,"otherNames":51},"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 .",[36,50],"4: placebo plus placebo",[52],"Saline solution in the OR",{"type":32,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"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.",[44,50],[58],"Saline solution in clinic",[60,64,67],{"measure":61,"description":62,"timeFrame":63},"Change in erectile function by IIEF","IIEF-5 is a tool to asses erectile dysfunction base on five questions about confidence, hardness, maintenance and satisfaction of erections. Score: 1 to 25.","from baseline to 6 months post treatment",{"measure":65,"description":66,"timeFrame":63},"Change in erectile function by Epic 26","This questionnaire is designated to measure Quality of Life issues.Clinical relevance (\\>12 points) for sexual function domain score as measured by EPIC-26.",{"measure":68,"description":69,"timeFrame":70},"Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE)","AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.\n\nSAE=a medical event that at any dose results in death, persistent or significant disability\u002Fincapacity or drug dependency\u002Fabuse; is life-threatening, an important medical event or a congenital anomaly\u002Fbirth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug","6 months",[72],{"measure":73,"description":74,"timeFrame":63},"Change in urinary function","This questionnaire is designated to measure Quality of Life issues.Clinically relevant (≥9 points) difference in the EPIC-26 urinary incontinence domain score","MALE","40 Years","70 Years",false,{"inclusion":80,"exclusion":81,"raw_text":82},[],[],"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   \\-",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":102},"Houston Methodist","Houston","Texas","77030","United States",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Vivian MacDonnell, CCRP","CONTACT","713-441-8113","vmmacdonnell@houstonmethodist.org",{"name":100,"role":101},"Brian Miles, MD","PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},29.76328,-95.36327,[],[],[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[19,111],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is a pilot study that is double-blind, meaning neither you nor your doctors will know if you are receiving HB-adMSCs or a placebo. About 40 participants will be randomly assigned to one of four treatment groups.","completed","Stem Cells for Erectile Dysfunction After Prostate Cancer Surgery","This study is looking at whether stem cells can help men who experience erectile dysfunction after surgery for prostate cancer (radical retropubic prostatectomy or RALP). Researchers are testing two ways to give allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs): either directly into the penis and surrounding nerves during surgery, or through an IV in a clinic visit. Some participants will receive HB-adMSCs, while others will receive a placebo (inactive substance) to compare the effects. The study aims to see if these stem cells improve erectile function and are safe. You may be able to join if you are a man between 40 and 70 years old, scheduled for RALP with Dr. B. Miles at Houston Methodist, and meet other health criteria.","Your erectile function and any side effects will be monitored for 6 months after treatment.",120,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]