Status:
RECRUITING
Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE)
Lead Sponsor:
Jumeirah American Clinic
Conditions:
Erectile Dysfunction
Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Eligibility:
MALE
30-75 years
Brief 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...
Detailed Description
Detailed Description: This prospective observational study is designed to evaluate the safety and preliminary efficacy of intracavernosal injections of autologous adipose tissue-derived stem cells (A...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06605508
Start Date
January 10 2025
End Date
December 31 2029
Last Update
August 26 2025
Active Locations (1)
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1
Jumeirah American Clinic
Dubai, Dubai, United Arab Emirates