40
Participants
Start Date
July 1, 2025
Primary Completion Date
June 30, 2027
Study Completion Date
June 30, 2027
Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office
2.00x10⁸ HB-adMSCs IV at the doctor's office.
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
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 .
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.
Houston Methodist, Houston
The Methodist Hospital Research Institute
OTHER