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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• Age: Adult males aged 30 to 75 years.

• Diagnosis: Confirmed diagnosis of erectile dysfunction (ED) of mild to moderate severity, as defined by an International Index of Erectile Function (IIEF) score.

• Treatment Response: Failure or suboptimal response to conventional ED treatments, such as PDE-5 inhibitors.

• General Health: Overall good health without contraindications to stem cell therapy.

• Informed Consent: Ability and willingness to provide written informed consent to participate in the study.

Locations
Other Locations
United Arab Emirates
Jumeirah American Clinic
RECRUITING
Dubai
Contact Information
Primary
Ranjith Ramasamy, MD
ranjith.ramasamy@jac.ae
+971 800 522823
Backup
Jessie Bagolor, RN
jessie.bagolor@jac.ae
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 30
Treatments
Intracavernosal Injection of Autologous Adipose Stem Cells for Erectile Dysfunction Treatment
In this arm of the study, participants will receive intracavernosal injections of autologous adipose tissue-derived stem cells (ADSC). The ADSC are collected from the participant's own body fat through a minimally invasive liposuction procedure. After processing, the stem cells will be injected directly into the erectile tissue of the penis. This treatment aims to improve erectile function by stimulating tissue regeneration and enhancing blood flow. Participants will be monitored for safety and efficacy, including erectile function assessments using the International Index of Erectile Function (IIEF) and penile hemodynamics measured by Doppler ultrasound. Follow-up evaluations will occur at 3, 6, 9, and 12 months post-treatment.
Intracavernosal Injection of Stem cell-derived exosomes
In this arm of the study, participants will receive intracavernosal injections of stem cell-derived exosomes. These exosomes, which are nano-sized extracellular vesicles obtained from cultured stem cells, are rich in growth factors and bioactive molecules that facilitate tissue repair and regeneration. Unlike stem cell therapy, this cell-free approach minimizes potential risks associated with live cell transplantation while still delivering therapeutic benefits. Participants will be monitored for safety and efficacy, including erectile function assessments using the International Index of Erectile Function (IIEF) and penile hemodynamics measured by Doppler ultrasound. Follow-up evaluations will occur at 3, 6, 9, and 12 months post-treatment.
Sponsors
Leads: Jumeirah American Clinic

This content was sourced from clinicaltrials.gov