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Stem Cells for Erectile Dysfunction Post RALP

RecruitingPhase 1/2

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

Who can join

Ages 40 to 70 · Men

Full eligibility criteria
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 .

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About the study

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.

What is being tested

Sponsor: The Methodist Hospital Research Institute · Participants: 40 · Started: Jul 7, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07048314

Locations in the U.S.

TexasHouston Methodist, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.