NCT06605508Recruiting
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
Source: ClinicalTrials.gov · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 18 Sept 2024
- Start date
- 10 Jan 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Jumeirah American Clinic
- Diseases
- Type 2 diabetes
- NCT number
- NCT06605508
What you commit to
- Study type: Observational
- Planned participants: 30
- From 10 Jan 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent Surgery or Trauma: Recent major surgeries or physical trauma that could impact the study or interfere with the intervention.
Other illness
- 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.
Other
- Participation in Other Studies: Participation in other clinical trials or studies that may affect the outcomes or safety of this study.
Who the study is looking for
- 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.
Age in the registry: 30 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jumeirah American Clinic Coordinator of this site? Confirm its status | Dubai | United Arab Emirates | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.