Stem cells to help erectile function after prostate surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, double-blind, four-arm pilot study evaluating safety and potential benefit of allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) for erectile function recovery after radical retropubic prostatectomy. Participants are randomized equally to receive local stem cell injections with or without intravenous stem cells, or placebo, at week 1 and week 12 as appropriate. The trial aims to determine safety and whether stem cell treatment can promote recovery of erectile function in this surgical population. Eligibility includes men aged 40-70 with localized prostate cancer undergoing RALP, adequate baseline erectile function, and willingness to participate in follow-up assessments.

Why it matters

Who can join: the full rules

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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Where it's running

• Houston Methodist
  Houston, Texas, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.