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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Liposuction using aspiration syringe and tumescent local anesthesia
Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia
Ageless Regenerative Institute LLC
Aventura, Florida, United States
Change from Baseline in Schramek's Grade
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
Time frame: Baseline, 3 months, and 6 months
Change from Baseline of Penile Doppler
Time frame: Baseline and 6 moths
Improvement in Phallometry Measures
Air Chamber Measurements/ Circumference Measurements
Time frame: Baseline, 3 Months, and 6 Months
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