Human Penile Allotransplantation

Trial Information
Who is this study for? Wounded Warriors and civilians who have lost their penis due to battle or traumatic injury
What treatments are being studied? Monoclonal Antibody+Tacrolimus+Penile Allotransplantation
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Am I eligible for this trial?
Participation Requirements
Sex:
Male
Minimum Age:
18
Maximum Age:
69
Healthy Volunteers:
No

• 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

• 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 immunomodulatory protocol, surgical procedure, or functional results (If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of penile transplantation.).

• No co-existing psycho-social problems (i.e., alcoholism, drug abuse).

• Negative for malignancy for past 5 years.

• Negative for HIV at transplant.

• Negative crossmatch with donor.

• Consents to sample (i.e., skin biopsy) collection and storage and bone marrow infusion as part of the treatment regimen.

• USA citizen or equivalent.

• Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regimen.

Where is this trial taking place?
United States
Maryland
Johns Hopkins University School of Medicine
Recruiting
Baltimore
Who do I contact about this trial?
Primary
Jane Littleton, CRNP, MSN
jlittl38@jhmi.edu
410-955-6875
Backup
TBD TBD
443-287-7848
When is this trial taking place?
Start Date: June 2014
Estimated Completion Date: June 2024
How many participants will be in this trial?
Target number of participants: 60
What treatment is being studied in this trial?
Experimental: Treatment: Transplantation
Penile transplantation with an immunomodulatory protocol consisting of monoclonal antibody induction therapy of humanized anti CD52 followed by donor bone marrow infusion and tacrolimus monotherapy.
Who are the authors of this trial?
What other conditions are being studied in this trial?

This content was sourced from clinicaltrials.gov