Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

Launched by HOSPICES CIVILS DE LYON · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new option for men who have experienced severe penile defects due to trauma or congenital conditions, such as micropenis. The study will look into penile transplantation, a procedure where a donor penis is surgically attached to a recipient. While this treatment has shown promise in other countries, this is the first time it will be tested in Europe. The goal is to understand how well this surgery works and what risks it may involve, especially regarding the need for medications that suppress the immune system.

To be eligible for this trial, participants must be adult males aged 18 to 60 who have severe penile defects from injury or congenital issues. They should be in generally good health and able to follow study procedures, including attending check-ups. Unfortunately, individuals with certain health conditions, such as uncontrolled infections or specific cancers, will not be able to participate. If accepted into the trial, participants can expect to undergo the penile transplantation procedure and will be closely monitored throughout the study to assess their recovery and overall health.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patient ≥ 18 years and ≤ 60 years
• • Patient with traumatic penile severe defects (amputation), or congenital penile defects (micropenis)
• • ASA ≤ 2
• • NYHA ≤ 1
• • Creatinine clearance \> 60 mL/min (CKD-EPI)
• • Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
• • Informed consent signed to participate to the study
• Exclusion Criteria:
• • Gender incongruence
• • Congenital penile defects resulting from exstrophy/epispadias
• • Penile malformation due to selh-half/self-amputation
• • Amputation for penile cancer
• • Other types of malignancy in remission for less than 5 years
• • Progressive malignant tumor
• • Presenting hepatitis B, hepatitis C, or HIV infection not controlled by appropriate anti-viral therapy
• • Uncontrolled arterial hypertension
• • Moderate renal failure : glomerular filtration rate of less than 60 mL/min per 1.73 m2
• • EBV sero-negative recipient with EBV sero-positive graft, due to the risk of lymphoma
• • Non controlled chronic infection
• • Malignancy, Connective tissue disease
• • Amyloidosis
• • Unbalanced diabetes
• • Patient with a contraindication to performing an MRI examination
• • Contra-indication of Thymoglobuline: Hypersensitivity to rabbit proteins or to any of the excipients of Thymoglobuline, acute or chronic infections that contraindicate any additional immunosuppression,
• • Contra-inducation of tacrolimus: Hypersensitivity to tacrolimus or others macrolides, or any of the excipients of PROGRAF,
• • Contra-indication of Mycophenolate mofetil: in patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or any of the excipients, Hypersensitivity reactions to mycophenolate mofetil;
• • History of major psychiatric disorders \< 3 years (psychotic disorders, severe substance abuse, severe personality disorders) or persons under psychiatric care ;
• • Person deprived of their liberty by a judicial or administrative decision ;
• • Person admitted to a health or social institution for purposes other than research
• • Adult subjects to a legal protection measure (guardianship, curatorship)
• • Person not affiliated to a social security scheme of beneficiaries of a similar scheme