NCT02087397

Autologous Adipose-Derived Stromal Cells Delivered Into the Corpus Cavernous in Patients With Erectile Dysfunction

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Corpus Cavernous in Patients With Erectile Dysfunction.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ageless Regenerative Institute · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction cells (AD-SVF) implantation delivered into the corpus cavernous in patients with Erectile Dysfunction. The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Erectile Dysfunction.

Detailed description

AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for direct injection to the Corpus Cavernosum (Penis).

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
OTHER	Liposuction	Liposuction using aspiration syringe and tumescent local anesthesia
BIOLOGICAL	AD-SVF Cell Injection	Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-11-01
• Completion: 2017-12-01
• First posted: 2014-03-14
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States