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NOT YET RECRUITING
NCT07048314
PHASE1/PHASE2

Stem Cells for Erectile Dysfunction Post RALP

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-10

Completion Date

2027-06-30

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

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

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

DRUG

Allogeneic 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

DRUG

Placebo 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 .

DRUG

Placebo 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