Clinical trial · Interventional
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
NCT07048314CI-TRIAL-00117579recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1/2 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office | Drug | — | UNRESOLVED |
| Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR | Drug | — | UNRESOLVED |
| Placebo in clinic | Drug | — | UNRESOLVED |
| Placebo in the OR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1: allogeneic adipose-derived mesnchymal stem cells plus saline solution
- description
- 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.
- interventionNames
- Drug: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR
- Drug: Placebo in clinic
- type
- EXPERIMENTAL
- label
- 2: Placebo plus allogeneic adipose-derived mesnchymal stem cells
- description
- 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.
- interventionNames
- Drug: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office
- Drug: Placebo in the OR
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients scheduled for RALP with Dr. B. Miles at Houston Methodist. 2. Men aged between 40 and 70 (inclusive) years old 3. Localized prostate cancer: Clinical stage T1-T2, N0, M0 4. Gleason score \< 7 5. Pre-op IIEF-5 \>20 (Appendix A) 6. Testosterone serum: \> 300ng/dl with normal Free Testosterone 7. Life expectancy of at least 10 years 8. Performance status of ≤ 2 (Zubrod scale). (Appendix B) 9. 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 10. Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery 11. Supportive partner willing to complete sexual survey questionnaire (Appendix D) 12. 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. 13. Patient need cardiac clearance by the cardiologist Exclusion Criteria: 1. Penile anatomical abnormalities (Peyronie's disease) 2. Hypogonadism 3. Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.) 4. Patients with AST levels above 40U/L ; ALT levels above 33 U/L and Glucose levels above 180 mg/dl and psychiatric disorders that require medication 5. Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug. 6. Any previous penile implant or penile vascular surgery 7. Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery . \-
References
Publications (0)
Data not yet available
No reference posted for this study.