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

Phase 1

Withdrawn

• Conditions: Erectile Dysfunction
• Interventions: Other: Liposuction; Biological: AD-SVF Cell Injection

• Registration Number: NCT02087397
• Lead Sponsor: Ageless Regenerative Institute

Brief 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).

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AD-SVF Cell Injection	AD-SVF Cell Injection	-
AD-SVF Cell Injection	Liposuction	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Schramek's Grade	Baseline, 3 months, and 6 months	Schramek's grading system- penile rigidity Grade 1 - No erection Grade 2 - Slight Tumescence Grade 3 - Full volume without rigidity Grade 4 - Sufficient for sexual intercourse Grade 5 - Full erection

Secondary Outcome Measures

Name	Time	Method
Change from Baseline of Penile Doppler	Baseline and 6 moths
Improvement in Phallometry Measures	Baseline, 3 Months, and 6 Months	Air Chamber Measurements/ Circumference Measurements

Trial Locations

Locations (1)

Ageless Regenerative Institute LLC; 🇺🇸 Aventura, Florida, United States