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New treatment option for Erectile Dysfunction
Official title Stem Cells for Erectile Dysfunction Post RALP
ClinicalTrials.gov ID: NCT07048314
What this study is testing
What is Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office?
Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for erectile dysfunction.
Also referred to as HB-adMSCs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70, men only
You may be able to join 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)
You likely 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
See the full eligibility 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
- 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 . \-
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.