NCT07048314RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 24 Jun 2025
- Start date
- 7 Jul 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- The Methodist Hospital Research Institute
- Diseases
- Prostate cancer
- NCT number
- NCT07048314
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 7 Jul 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.)
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug.
- Any previous penile implant or penile vascular surgery
- Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery .
- \-
Other illness
- Penile anatomical abnormalities (Peyronie's disease)
Lab values
- 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
Other
- Hypogonadism
Who the study is looking for
- Patients scheduled for RALP with Dr. B. Miles at Houston Methodist.
- Men aged between 40 and 70 (inclusive) years old
- Localized prostate cancer: Clinical stage T1-T2, N0, M0
- Gleason score \< 7
- Pre-op IIEF-5 \>20 (Appendix A)
- Testosterone serum: \> 300ng/dl with normal Free Testosterone
- Life expectancy of at least 10 years
- Performance status of ≤ 2 (Zubrod scale). (Appendix B)
- 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
- Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery
- Supportive partner willing to complete sexual survey questionnaire (Appendix D)
- 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.
- Patient need cardiac clearance by the cardiologist
Age in the registry: 40 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.