Injections of stem cells from fat tissue to treat erectile dysfunction
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
Jumeirah American Clinic · NCT06605508
This study is testing if injections of stem cells from fat can help men aged 30 to 75 with erectile dysfunction who haven't found relief from other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | Male |
| Sponsor | Jumeirah American Clinic (other) |
| Locations | 1 site (Dubai, Dubai) |
| Trial ID | NCT06605508 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of injecting autologous adipose tissue-derived stem cells (ADSCs) or stem cell-derived exosomes into the penis for men aged 30 to 75 with erectile dysfunction (ED) who have not responded to standard treatments. Participants will receive these injections and undergo assessments to measure improvements in erectile function using the International Index of Erectile Function (IIEF) score, as well as blood flow changes monitored by Doppler ultrasound. Follow-up visits will occur at 3, 6, 9, and 12 months to track long-term effects and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 30 to 75 with mild to moderate erectile dysfunction and a history of inadequate response to PDE-5 inhibitors.
Not a fit: Patients with severe cardiovascular disease, active infections, or a history of malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for men with erectile dysfunction who do not respond to conventional therapies.
How similar studies have performed: While regenerative medicine approaches for erectile dysfunction are emerging, this specific method using ADSCs is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Severe Cardiovascular Disease: Presence of severe cardiovascular conditions, including uncontrolled hypertension or significant heart disease. * Active Infections: Ongoing infections that could interfere with treatment or pose a risk to the participant. * Malignancies: History of or current cancer, including malignancies that could affect safety or treatment outcomes. * Contraindications to Stem Cell Therapy: Any medical conditions or treatments that contraindicate the use of stem cell therapy. * Uncontrolled Diabetes: Poorly controlled diabetes or other metabolic disorders that could impact treatment efficacy or safety. * Psychiatric or Cognitive Impairments: Significant psychiatric or cognitive disorders that may affect the participant\'s ability to comply with study protocols or provide informed consent. * Recent Surgery or Trauma: Recent major surgeries or physical trauma that could impact the study or interfere with the intervention. * Participation in Other Studies: Participation in other clinical trials or studies that may affect the outcomes or safety of this study.
Where this trial is running
Dubai, Dubai
- Jumeirah American Clinic — Dubai, Dubai, United Arab Emirates (RECRUITING)
Study contacts
- Study coordinator: Ranjith Ramasamy, MD
- Email: ranjith.ramasamy@jac.ae
- Phone: +971 800 522823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Erectile Dysfunction Following Radical Prostatectomy, stem cell therapy, Erectile dysfunction, Autologous adipose tissue-derived stem cells, Regenerative medicine for ED, Exosomes