Stem Cells for Erectile Dysfunction Post RALP

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Erectile DysfunctionProstate Cancer
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.

Trial Locations (1)

77030

Houston Methodist, Houston

All Listed Sponsors
lead

The Methodist Hospital Research Institute

OTHER