Injuries to the genitalia are of concern to the military with emphasis placed on the surgical
reconstruction and psychological health of these Wounded Warriors. However, despite
significant surgical advances in microvascular surgery and autologous free tissue transfer,
conventional reconstructions cannot truly replace the complicated structures and functions of
the penis including the urethra, erogenous sensation, and erectile corporal bodies.
Conventional reconstruction poses several challenges: patients may not have sufficient donor
tissue due to other injuries or previous surgery; multiple operations are often needed to
restore the neophallus; the final reconstruction only approximates the penis' native form;
recreating the urethra is challenging and the new urethra is prone to stricture and fistula
formation; the erectile function necessary for sexual intercourse is often lacking; and
insufficient protective sensation can lead to penile implant extrusion, infection, subsequent
explantation or loss of the reconstruction.
The investigators propose this clinical trial to determine functional outcomes and quality of
life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The
investigators will combine extensive experience performing total penile reconstruction in a
large population affected by congenital, traumatic, and therapeutically extirpated
Genitourinary deformities and expertise in reconstructive transplantation using an
immunomodulatory protocol to for this study. The investigators anticipate penile
transplantation can potentially replace "like with like," restoring the appearance, anatomy,
and function of the recipient in a manner far superior to autologous reconstruction. This
project will establish the ability to perform penile allotransplantation using an
immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient
results.
Study Design: This is a non-randomized subject self-controlled clinical trial to implement a
cell-based immunomodulatory protocol for penile allotransplantation. An intermediate
deliverable is achieving allograft survival and functional return with reduced
dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus)
immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes
when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months
post-transplant.