Stem Cells for Erectile Dysfunction After Prostate Cancer Surgery
This study is looking at whether stem cells can help men who experience erectile dysfunction after surgery for prostate cancer (radical retropubic prostatectomy or RALP). Researchers are testing two ways to give allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs): either directly into the penis and surrounding nerves during surgery, or through an IV in a clinic visit. Some participants will receive HB-adMSCs, while others will receive a placebo (inactive substance) to compare the effects. The study aims to see if these stem cells improve erectile function and are safe. You may be able to join if you are a man between 40 and 70 years old, scheduled for RALP with Dr. B. Miles at Houston Methodist, and meet other health criteria.
- Study design
- This is a pilot study that is double-blind, meaning neither you nor your doctors will know if you are receiving HB-adMSCs or a placebo. About 40 participants will be randomly assigned to one of four treatment groups.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your erectile function and any side effects will be monitored for 6 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Stem Cells for Erectile Dysfunction Post RALP
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Change in erectile function by IIEFfrom baseline to 6 months post treatment
IIEF-5 is a tool to asses erectile dysfunction base on five questions about confidence, hardness, maintenance and satisfaction of erections. Score: 1 to 25.
- Change in erectile function by Epic 26from baseline to 6 months post treatment
This questionnaire is designated to measure Quality of Life issues.Clinical relevance (\>12 points) for sexual function domain score as measured by EPIC-26.
- 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)6 months
AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug