Prospective Observational Study on Intracavernosal Injection of Autologous Adipose Tissue-Derived Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction

What this Trial Is About

This research aims to evaluate whether injections of stem cells derived from a man's own fat tissue can improve erectile function in men aged 30 to 75 who have erectile dysfunction and have not responded well to standard treatments like PDE-5 inhibitors (e.g., Viagra). The study focuses on measuring changes in erectile function using the International Index of Erectile Function (IIEF) score and assessing blood flow changes in the penis with Doppler ultrasound. It also explores biomarkers that may predict treatment response and monitors safety throughout the study. Participants will receive one of two treatments: intracavernosal injections of autologous adipose tissue-derived stem cells collected via minimally invasive liposuction, or intracavernosal injections of stem cell-derived exosomes, which are cell-free vesicles containing growth factors. Both treatments involve injecting directly into the erectile tissue of the penis, followed by a 15-minute tourniquet application to reduce systemic spread. Follow-up visits will occur at 3, 6, 9, and 12 months after treatment to evaluate effects and safety. During the study, participants will undergo baseline assessments including erectile function scoring, penile Doppler ultrasound, and blood tests. Follow-up visits will include repeated IIEF scoring, Doppler ultrasound to assess penile blood flow, monitoring for adverse events, and collection of biological samples for biomarker analysis. Researchers will track changes in erectile function and penile hemodynamics over 12 months to evaluate the treatments' safety and preliminary effectiveness. Overall participation lasts about one year, with multiple scheduled assessments.

Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE)