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
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.
Description
This is a prospective, single-center, double blind, four-arm, pilot study to evaluate safety and effectiveness of allogeneic stem cells promoting the recovery of erectile function in patients undergoing radical retropubic prostatectomy (RALP) of localized prostate cancer. All participants will be assessed for eligibility Participants will be randomized in a 1:1:1:1 ratio to Arm 1, Arm 2, Arm 3 or Arm 4 using a validated system that automates the random assignment of participant numbers to randomization numbers. Study participants will be randomized to receive either: Arm 1 2.00x 10⁸ HB-adMS…
Eligibility
- Age range
- 40–70 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients scheduled for RALP with Dr. B. Miles at Houston Methodist. 2. Men aged between 40 and 70 (inclusive) years old 3. Localized prostate cancer: Clinical stage T1-T2, N0, M0 4. Gleason score \< 7 5. Pre-op IIEF-5 \>20 (Appendix A) 6. Testosterone serum: \> 300ng/dl with normal Free Testosterone 7. Life expectancy of at least 10 years 8. Performance status of ≤ 2 (Zubrod scale). (Appendix B) 9. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution 10. Patient…
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.
Location
- Houston MethodistHouston, Texas