Stem Cells for Erectile Dysfunction Post RALP
Recruiting · NCT07048314 · Interventional (participants receive a specific treatment) · Lead sponsor: The Methodist Hospital Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's officeAllogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the ORPlacebo in clinicPlacebo in the OR
What this trial is about
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.
Who can take part
Age range
40 Years to 70 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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 .
Where it is running
1 location listed across 1 US state.
- Houston Methodist - Houston, Texas, United States