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Stem Cells for Erectile Dysfunction Post RALP
Sponsor: The Methodist Hospital Research Institute
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
Conditions
Interventions
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.
Locations (1)
Houston Methodist
Houston, Texas, United States