Human Penile Tissue Allotransplantation for Devastating Penile and Concomitant Genital Trauma
Status:
Withdrawn
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Anthony Atala Wake Forest University Health Sciences