Erectile Dysfunction (ED) Clinical Trials

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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

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1/Phase 2

SUMMARY

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.

Eligibility

Participation Requirements

Sex: Male

Minimum Age: 40

Maximum Age: 70

Healthy Volunteers: f

View:

• 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

Locations

United States

Texas

Houston Methodist

RECRUITING

Houston

Time Frame

Start Date: 2026-07-07

Estimated Completion Date: 2027-06-30

Participants

Target number of participants: 40

Treatments

Experimental: 1: allogeneic adipose-derived mesnchymal stem cells plus saline solution

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.

Experimental: 2: Placebo plus allogeneic adipose-derived mesnchymal stem cells

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.

Experimental: 3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinic

2.00x 10⁸ HB-adMSCs 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 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.

Placebo_comparator: 4: placebo plus placebo

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 saline solutin via IV in clinic at week 12.

Related Therapeutic Areas

Prostate Cancer

Prostatectomy

Erectile Dysfunction (ED)