Penile Allotransplantation Using Immunomodulatory Treatment for Men with Penile Loss or Injury A Study to Improve Function and Quality of Life Compared to Conventional Reconstruction

What this Trial Is About

Researchers are evaluating penile allotransplantation using a special immunomodulatory protocol to improve outcomes for men who have lost their penis due to traumatic injury, cancer, or congenital defects. The study focuses on Wounded Warriors and civilians, aiming to restore the peniss appearance, anatomy, and function more effectively than conventional reconstructive surgery. This clinical trial is designed as a non-randomized, self-controlled study assessing functional outcomes and quality of life over several years. Participants will undergo penile transplantation combined with an immunomodulatory treatment protocol that includes monoclonal antibody induction therapy, donor bone marrow infusion, and tacrolimus monotherapy to reduce the need for high-dose immunosuppression. The study aims to achieve allograft survival and functional return, with reduced immunosuppressive treatment, and to compare these results against conventional surgical reconstruction outcomes over 12 to 60 months post-transplant. During the study, participants will be closely monitored for graft survival and undergo multiple assessments of quality of life, sexual function, psychological well-being, and pain using standardized questionnaires and scales. Follow-up evaluations will continue for up to five years to measure long-term outcomes related to transplantation success, patient satisfaction, and overall health. Participants must comply with the treatment regimen and attend scheduled visits for ongoing monitoring throughout the study period.

Human Penile Allotransplantation