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ClinicalTrials.gov ID

NCT06781606

Lead Sponsor

Hospices Civils de LyonOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

3Estimated

Last Update Posted

Jan 17, 2025Actual

Start Date

Jun 1, 2025Estimated

Primary Completion Date

Jun 1, 2030Estimated

Completion Date

Jun 1, 2031Estimated

Official Title

Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

Brief Summary

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.

• Adults with Traumatic Penile Severe Defects
• Congenital Penile Defects
• Micropenis

• Penile transplantation

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

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

Primary Purpose

Supportive Care

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Hospices Civils de LyonOTHER

Collaborators

French Association of UrologyUNKNOWN

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