What this study is
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.
What's being tested
- Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office
Intervention · DRUG
2.00x10⁸ HB-adMSCs IV at the doctor's office.
- Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR
Intervention · DRUG
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
Intervention · DRUG
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
Intervention · DRUG
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.
Study details
- 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
- Sponsor
- The Methodist Hospital Research Institute
- Conditions
- Erectile Dysfunction · Prostate Cancer
- Enrolling
- 40 people
- Starts
- 2026-07-07
- Est. completion
- 2027-06-30
- Design
- Double-blind, randomized, factorial, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 70 YearsSex MALEHealthy volunteers Not acceptedYou may qualify if
- Patients scheduled for RALP with Dr. B. Miles at Houston Methodist.
- Men aged between 40 and 70 (inclusive) years old
- Localized prostate cancer: Clinical stage T1-T2, N0, M0
- Gleason score < 7
- Pre-op IIEF-5 >20 (Appendix A)
- Testosterone serum: > 300ng/dl with normal Free Testosterone
- Life expectancy of at least 10 years
- Performance status of ≤ 2 (Zubrod scale). (Appendix B)
- 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
- Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery
- Supportive partner willing to complete sexual survey questionnaire (Appendix D)
- PDE5 inhibitors like sildenafil, tadalafil, vardenafil and avanafil are permitted pre and post-surgery if participant was taking this for ED at least 6 months before surgery.
- Patient need cardiac clearance by the cardiologist
You can't join if
- Penile anatomical abnormalities (Peyronie's disease)
- Hypogonadism
- Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.)
- Patients with AST levels above 40U/L; ALT levels above 33 U/L and Glucose levels above 180 mg/dl and psychiatric disorders that require medication
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug.
- Any previous penile implant or penile vascular surgery
- Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery . -
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHouston Methodist
Houston, Texas, United States
- Vivian MacDonnell, CCRP · Contact713-441-8113vmmacdonnell@houstonmethodist.org
- Brian Miles, MD · Principal investigator
Recruiting
Study team
Sponsor
The Methodist Hospital Research Institute
Study ID Pro00039638
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.