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

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

January 10, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
Erectile DysfunctionErectile Dysfunction Associated With Type 2 Diabetes MellitusErectile Dysfunction Following Radical Prostatectomy
Interventions
PROCEDURE

Autologous Adipose Tissue-Derived Stem Cell Injection for Erectile Dysfunction

This intervention involves the use of autologous adipose tissue-derived stem cells (ADSC) to treat erectile dysfunction. The process begins with a minimally invasive liposuction procedure to harvest fat tissue from the participant\'s own body. The harvested fat is then processed to isolate stem cells, which are subsequently injected directly into the erectile tissue of the penis. This approach aims to enhance erectile function by promoting tissue regeneration and improving blood flow. Unlike other treatments for erectile dysfunction, this intervention uses stem cells derived from the participant\'s own fat, which may reduce the risk of immune rejection and offer a novel regenerative therapy option. The treatment is designed to address ED in patients who have not responded adequately to conventional therapies like PDE-5 inhibitors.

PROCEDURE

Stem cell-derived Exosomes Injection for Erectile Dysfunction

This intervention involves the use of stem cell-derived exosomes to treat erectile dysfunction. Exosomes are nano-sized extracellular vesicles secreted by stem cells, containing bioactive molecules such as growth factors and signaling proteins that promote tissue repair and regeneration. Unlike therapies requiring the transplantation of live cells, this cell-free approach eliminates the need for invasive harvesting procedures. The exosomes are carefully purified from cultured stem cells and prepared for direct injection into the erectile tissue of the penis. This approach aims to enhance erectile function by stimulating tissue regeneration, reducing inflammation, and improving blood flow. Unlike other treatments for erectile dysfunction, exosome therapy offers a novel regenerative option, potentially benefiting patients who have not responded adequately to conventional therapies such as PDE-5 inhibitors.

Trial Locations (1)

Unknown

RECRUITING

Jumeirah American Clinic, Dubai

All Listed Sponsors
lead

Jumeirah American Clinic

OTHER