NCT03240822

Human Penile Tissue Allotransplantation for Devastating Penile and Concomitant Genital Trauma

Vascularized Composite Allotransplantation (VCA) for Devastating Penile and Concomitant Genital Trauma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This is a 4-year, non-randomized, single center, patient self-controlled, clinical trial (though enrolled subjects will be followed for life as are all transplant patients) for patients seeking allotransplantation of the male external genitalia (MEG), or penile tissue, as a feasible reconstructive strategy for the treatment of devastating and irreversible injuries to the genitalia. In addition to receiving penile allotransplantation and post-operative monitoring and support, enrolled patients will receive an innovative and clinically proven immunomodulatory protocol that combines lymphocyte depletion of the recipient with donor bone marrow cell infusion. Patients will be treated with lymphocyte depleting induction therapy, donor bone marrow cell infusion and tacrolimus. After the first year, maintenance immunosuppression will be modified gradually and cautiously (tapered dose reduction or spaced frequency dosing of tacrolimus) in selected patients based on a critical evaluation of clinical and immunologic outcomes. Outcomes will include but not be limited to functional metrics (sensation, erection, voiding), psychosocial (body integrity, adaptation to transplant) and health related quality of life (HRQOL) measures.

Detailed description

Initial treatment with an antibody targeting recipient immune cells followed by triple-drug maintenance therapy represents the current standard in clinical VCA. Our protocol is different from the existing conventional drug treatments used in MEG allotransplantation in that it combines donor bone marrow infusion with an immunosuppression sparing protocol. The primary goal of this pilot clinical trial is to determine the feasibility of using allogeneic penile tissue to repair/replace irreversibly damaged external genitalia. Enrolled and transplanted subjects will be followed for their lifetime as a transplant patient.

Conditions

• Urologic Injuries
• Genital Diseases, Male
• Amputation

Interventions

Type	Name	Description
PROCEDURE	Penile Transplant	Penile Allotransplantation
BIOLOGICAL	Monoclonal Antibody (Humanized Anti-CD52)
DRUG	Tacrolimus

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-12-01
• Completion: 2025-12-01
• First posted: 2017-08-07
• Last updated: 2021-04-14

Regulatory

• FDA-regulated drug study