Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts (PETRA-VCA)

Civil Hospices of Lyon

Status

Not yet enrolling

Conditions

Micropenis

Adults with Traumatic Penile Severe Defects

Congenital Penile Defects

Treatments

Procedure: Penile transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT06781606

69HCL22_0906

2024-A02180-47 (Other Identifier)

Details and patient eligibility

About

Penile transplantation (PT) has recently emerged as an option for penile reconstruction and has shown encouraging outcomes at the international level with two ongoing PT program (US, South Africa). Emergence of such option has been possible thanks to the development of vascularized composite allotransplantation and because of the important limitations of autologous reconstruction (phalloplasty). Feasibility has already been proven, but the surgical management remains in its infancy and has never been tested at a European level. Furthermore, the balance between functional improvement and immunosuppressive risk still needs to be enlightened.

Enrollment

3 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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