Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE)

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

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.

Conditions4

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