The primary objective of this clinical trial is to evaluate the safety of autologous engineered corpora cavernosa + albuginea constructs for treatment of complex penile deformities. Autologous endothelial and smooth muscle cells obtained from enrolled subjects' corpora cavernosa biopsy sample, will be culture expanded in vitro and used to seed decellularized corpora cavernosa + albuginea obtained from cadaveric-donors to create autologous bioengineered corpora cavernosa/albuginea constructs for repair of damaged penile tissues.
Males aged 18-60 years.
Acquired structural abnormalities of the corpora cavernosum secondary to trauma, infection, inflammation, or fibromatosis. These abnormalities will be diagnosed by clinical examination, and/or ultrasound, and/or computerized tomography.
Stable abnormalities - at least 6 months with no pain or changes in deformity.
At least one failed attempt at management by conventional approaches at least 6 months prior to enrollment
Presence of untreated or incompletely treated urinary tract infection at the time of biopsy.
Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders.
Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease.
ALT or AST value >1.5 times the upper limit of normal.
Single group
Autologous tissue engineered corpora
Biological/Vaccinepenile tissue construct
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
rate of adverse events reported for each patient
Number of participants with graft thrombosis or grant failures
lack of graft thrombosis or graft failure
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Wake Forest University Health Sciences
Lead sponsor
United States Department of Defense
Collaborator
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