Stem Cells for Erectile Dysfunction Post RALP

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a special type of stem cells taken from fat tissue can help men regain erectile function after surgery to remove the prostate gland for localized prostate cancer. The goal is to see if these stem cells are safe and if they can improve recovery of erections when given at different times compared to a placebo (a treatment with no active stem cells). This is an early-stage study, so it focuses on safety and gathering initial information about how well the treatment might work.

Men between the ages of 40 and 70 who have localized prostate cancer and are scheduled to have prostate removal surgery with a specific doctor at Houston Methodist may be eligible. Participants should have good erectile function before surgery, normal testosterone levels, and be generally healthy enough to live at least 10 more years. They will need to agree to try having sex at least five times a month after surgery once urinary control is regained, and their partner should be willing to help by completing surveys about sexual health. The study also allows men who were already taking common erectile dysfunction medications before surgery to continue using them. Participants can expect close monitoring for safety and will be part of a careful comparison to see if the stem cell treatment helps improve erectile function after prostate surgery.

Gender

MALE

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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