Injections of stem cells from fat tissue to treat erectile dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.