RecruitingNCT06605508

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

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

Sponsor

Jumeirah American Clinic

Enrollment

30 participants

Start Date

Jan 10, 2025

Study Type

OBSERVATIONAL

Conditions

Erectile Dysfunction Erectile Dysfunction Following Radical Prostatectomy Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Summary

The goal of this prospective observational study is to evaluate whether injections of stem cells derived from the patient's own fat tissue (adipose tissue) can improve erectile function in men aged 30 to 75 who have erectile dysfunction (ED) and have not responded well to standard treatments like PDE-5 inhibitors (e.g., Viagra). The main questions the study aims to answer are: Will the stem cell injections improve erectile function, as measured by the International Index of Erectile Function (IIEF) score? Are there any changes in blood flow to the penis, which will be measured using a Doppler ultrasound? Participants will: Receive injections of their own stem cells (obtained from a biopsy of fat) directly into the penis. Undergo assessments to check erectile function before and after treatment. Have follow-up visits at 3, 6, 9, and 12 months to monitor long-term effects. The study will also look for any possible side effects or complications and evaluate biological markers in the penis that may indicate the effectiveness of the treatment. Participants will be recruited from clinic where they are already receiving care for ED. To take part, they must be in good overall health, with no severe heart disease, uncontrolled diabetes, cancer, or other conditions that could make stem cell therapy unsafe for them.

Eligibility

Sex: MALEMin Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injections of stem cells or substances released by stem cells (called exosomes) can help men with erectile dysfunction (ED) who haven't responded well to standard treatments like Viagra or similar medications. The goal is to help restore normal sexual function using the body's own regenerative processes. **You may be eligible if...** - You are a male between 30 and 75 years old - You have mild to moderate erectile dysfunction confirmed by a standard questionnaire (IIEF score) - You have tried and had poor results with standard ED medications like PDE-5 inhibitors (e.g., sildenafil/Viagra) - You are in generally good health with no contraindications to stem cell therapy - You can give written informed consent **You may NOT be eligible if...** - You have severe cardiovascular disease, uncontrolled high blood pressure, or significant heart disease - You have an active infection - You have severe ED Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAutologous Adipose Tissue-Derived Stem Cell Injection for Erectile Dysfunction

This intervention involves the use of autologous adipose tissue-derived stem cells (ADSC) to treat erectile dysfunction. The process begins with a minimally invasive liposuction procedure to harvest fat tissue from the participant\'s own body. The harvested fat is then processed to isolate stem cells, which are subsequently injected directly into the erectile tissue of the penis. This approach aims to enhance erectile function by promoting tissue regeneration and improving blood flow. Unlike other treatments for erectile dysfunction, this intervention uses stem cells derived from the participant\'s own fat, which may reduce the risk of immune rejection and offer a novel regenerative therapy option. The treatment is designed to address ED in patients who have not responded adequately to conventional therapies like PDE-5 inhibitors.

PROCEDUREStem cell-derived Exosomes Injection for Erectile Dysfunction

This intervention involves the use of stem cell-derived exosomes to treat erectile dysfunction. Exosomes are nano-sized extracellular vesicles secreted by stem cells, containing bioactive molecules such as growth factors and signaling proteins that promote tissue repair and regeneration. Unlike therapies requiring the transplantation of live cells, this cell-free approach eliminates the need for invasive harvesting procedures. The exosomes are carefully purified from cultured stem cells and prepared for direct injection into the erectile tissue of the penis. This approach aims to enhance erectile function by stimulating tissue regeneration, reducing inflammation, and improving blood flow. Unlike other treatments for erectile dysfunction, exosome therapy offers a novel regenerative option, potentially benefiting patients who have not responded adequately to conventional therapies such as PDE-5 inhibitors.