Human Penile Allotransplantation

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT02395497
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Amputation
  • Amputation, Traumatic
  • Amputation, Traumatic/Surgery
  • Congenital Anomaly, Male Genitalia
  • Penis/Injuries
  • Penis/Surgery
  • Penis/Transplantation
  • Urologic Surgical Procedures, Male
  • Wounds and Injuries

Eligibility Criteria

Sex
MALE
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Monoclonal Antibody (Humanized Anti-CD52) — BIOLOGICAL
  • Tacrolimus — DRUG
  • Penile Allotransplantation — PROCEDURE

Study Details

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.

Key Dates

Start date
Jun 30, 2014
Status verified
Jul 2025
Primary completion
Jun 30, 2034
Completion
Jun 30, 2039

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Allograft Survival [ Time Frame: Transplantation through end of study period (up to 5 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21287
Carisa Cooney, MPH,CCRP
[email protected]
443-287-4629
TBD TBD
443-287-7848
Richard Redett, MD (PRINCIPAL_INVESTIGATOR)
Damon Cooney, MD,PHD (SUB_INVESTIGATOR)
Gerald Brandacher, MD (SUB_INVESTIGATOR)
Arthur Burnett, MD (SUB_INVESTIGATOR)

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Johns Hopkins University School of Medicine· Baltimore, MD

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