RecruitingPhase 1Phase 2NCT07048314

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


Sponsor

The Methodist Hospital Research Institute

Enrollment

40 participants

Start Date

Jul 7, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office, a drug called Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR, and others for people with erectile dysfunction and prostate cancer. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 40 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAllogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office

2.00x10⁸ HB-adMSCs IV at the doctor's office.

DRUGAllogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR

100 million stem cells (1.00x10⁸ HB-adMSCs) in the corpora cavernosa of the penis suspended in a 4 cc of sterile saline. 50 million stem cells (5.0x 10⁷ HB-adMSCs) along the right neurovascular bundle and 50 million cell (5.0x 10⁷ HB-adMSCs) along the left neurovascular bundle of the penis suspended in a 4 cc of sterile saline during the surgery

DRUGPlacebo in the OR

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 during the surgery .

DRUGPlacebo in clinic

30 mL syringe of the product should be mixed into a 250cc bag of sodium chloride solution 0.9% for infusion. should be administered intravenously, with a dosing rate of 4-5mL/min.


Locations(1)

Houston Methodist

Houston, Texas, United States

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NCT07048314


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