Stem Cells for Erectile Dysfunction Post RALP (NCT07048314) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Stem Cells for Erectile Dysfunction Post RALP
United States40 participantsStarted 2026-03-10
Plain-language 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.
Who can participate
Age range40 Years – 70 Years
SexMALE
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Inclusion criteria
✓. Patients scheduled for RALP with Dr. B. Miles at Houston Methodist.
✓. Men aged between 40 and 70 (inclusive) years old
✕. 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
What they're measuring
1
Change in erectile function by IIEF
Timeframe: from baseline to 6 months post treatment
2
Change in erectile function by Epic 26
Timeframe: from baseline to 6 months post treatment
3
Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE)