Human Penile Tissue Allotransplantation for Devastating Penile and Concomitant Genital Trauma

NCT03240822 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: IRB00027539
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urologic Injuries; Genital Diseases, Male; Amputation

Keywords

Penile Trauma; Allotransplantation; Vascularized Composite Allotransplantation; VCA; Genital Trauma; Penile Transplantation; Amputation; Penile Injury

Outcome Measures

Primary Outcomes (1)

• Need for Immunosuppressive drug therapy

  The amount of immunosuppressive drug therapy will be recorded.

  6 months

Secondary Outcomes (6)

• erectile function

  6 months

• Assessment of sensory return and sensory thresholds

  6 months

• Determination of hemodynamic status

  6 months

• The Reintegration to Normal Living (RNL) Index

  6 months

• The Situational Inventory of Body-Image Dysphoria (SIBID)

  6 months

Study Arms (1)

Penile Allotransplant and Immunosuppression Treatment

EXPERIMENTAL

Penile transplantation with monoclonal antibody induction therapy of humanized anti CD52 followed by donor bone marrow infusion and tacrolimus monotherapy.

Procedure: Penile Transplant; Biological: Monoclonal Antibody (Humanized Anti-CD52); Drug: Tacrolimus

Interventions

Penile Transplant PROCEDURE

Penile Allotransplantation

Penile Allotransplant and Immunosuppression Treatment

Monoclonal Antibody (Humanized Anti-CD52) BIOLOGICAL

Penile Allotransplant and Immunosuppression Treatment

Tacrolimus DRUG

Penile Allotransplant and Immunosuppression Treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: This is a male, penile transplantation study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• years
• Irreversible and devastating genitalia damage not amenable to conventional reconstruction.
• Patent main vessels leading into the remaining penile stump, as confirmed by angiography.
• Adequate penile stump (\> 2.5cm) to facilitate placement of a tourniquet, debridement of the distal portion and sufficient distal mobilization of the structures requiring anastomosis
• Eligible for long term standard of care coverage

You may not qualify if:

• Documented history of:
• cancer
• renal impairment
• hepatic disorders
• neurologic disorders (sensory or motor function deficits)
• severe scarring with poor host tissue bed
• penile resection or implant surgery
• diabetes
• hypertension
• hyperlipidemia
• coronary artery disease
• untreated genital cancer
• HIV, Hepatitis B or C, or any infectious disease
• erectile dysfunction
• Peyronie's disease

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Genital Diseases, Male

Interventions

Antibodies, Monoclonal; Tacrolimus

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Macrolides; Lactones; Organic Chemicals

Study Officials

• Anthony Atala, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects receive transplant and immunosuppression therapy

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: April 14, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share