NCT02395497 Human Penile Allotransplantation
| NCT ID | NCT02395497 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Johns Hopkins University |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2014-06 |
| Primary Completion | 2034-06 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Donor Inclusion Criteria: * Males aged 16 - 65 years. * Brain dead meeting the criteria for Determination of Death. * Family consent for penile graft donation. * Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure). * Same blood type as recipient. * Negative lymphocytotoxic crossmatch. * Accurately matched for skin tone Recipient Inclusion Criteria: * Males of any race, color or ethnicity; aged 18-69 years. * Recent (≥6 months) or remote (i.e., several decades) penile injury resulting in the loss of ≥75% of the phallus. * Penectomy secondary to penile cancer * Penile Cancer Survivors \> 5 years * Micropenis associated with congenital/birth defect and severely ambiguous male genitalia * Must have completed a clinic appointment with one of the study surgeons to discuss all penile reconstructive options. * Completes the protocol informed consent form(s). * No co-existing medical condition which, in the opinion of the study team, could affect the immunomo