💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 is willing to attempt intercourse at least 5 times per month following urinary control after surgery
11. Supportive partner willing to complete sexual survey questionnaire (Appendix D)
12. 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.
13. Patient need cardiac clearance by the cardiologist
Exclusion Criteria:
1. Penile anatomical abnormalities (Peyronie's disease)
2. Hypogonadism
3. Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.)
4. 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
5. Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug.
6. Any previous penile implant or penile vascular surgery
7. Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery .
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HealthTeky