Human Penile Tissue Allotransplantation for Devastating Penile and Concomitant Genital Trauma
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 8/17/2018 |
| Start Date: | January 2017 |
| End Date: | December 2025 |
| Contact: | Mary-Clare Day, RN BSN |
| Email: | mday@wakehealth.edu |
| Phone: | (336) 713-1343 |
Vascularized Composite Allotransplantation (VCA) for Devastating Penile and Concomitant Genital Trauma
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.
(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.
Initial treatment with an antibody targeting recipient immune cells followed by triple-drug
maintenance therapy represents the current standard in clinical VCA. Our protocol is
different from the existing conventional drug treatments used in MEG allotransplantation in
that it combines donor bone marrow infusion with an immunosuppression sparing protocol. The
primary goal of this pilot clinical trial is to determine the feasibility of using allogeneic
penile tissue to repair/replace irreversibly damaged external genitalia. Enrolled and
transplanted subjects will be followed for their lifetime as a transplant patient.
maintenance therapy represents the current standard in clinical VCA. Our protocol is
different from the existing conventional drug treatments used in MEG allotransplantation in
that it combines donor bone marrow infusion with an immunosuppression sparing protocol. The
primary goal of this pilot clinical trial is to determine the feasibility of using allogeneic
penile tissue to repair/replace irreversibly damaged external genitalia. Enrolled and
transplanted subjects will be followed for their lifetime as a transplant patient.
Inclusion Criteria: For Recipients
1. Male
2. 18-40 years
3. Irreversible and devastating genitalia damage not amenable to conventional
reconstruction.
4. Patent main vessels leading into the remaining penile stump, as confirmed by
angiography.
5. 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
6. Eligible for long term standard of care coverage
Exclusion Criteria: For Recipients
1. Documented history of:
1. cancer
2. renal impairment
3. hepatic disorders
4. neurologic disorders (sensory or motor function deficits)
5. severe scarring with poor host tissue bed
6. penile resection or implant surgery
7. diabetes
8. hypertension
9. hyperlipidemia
10. coronary artery disease
11. untreated genital cancer
12. HIV, Hepatitis B or C, or any infectious disease
13. erectile dysfunction
14. Peyronie's disease
15. urethral stricture disease
16. balanitis
17. xerotica obliterans
18. pelvic embolization
19. pelvic radiation
20. untreated hypogonadism
21. prior prostate surgery
22. recurrent urinary tract infections (UTIs)
23. nephrolithiasis
24. connective tissue disease or collagen disease
25. lipopolysaccharidosis or amyloidosis
2. Use of 5-alpha-reductase inhibitors
3. External signs, sequelae or positive serology of sexually transmitted disease
(including HPV)
4. Active UTI, stones, urethral edema and other pathology that prevents urethral
anastomosis
5. Current or past substance abuse
6. Current or past smoker (within past 3 months)
7. Use of any medications known to cause vasoconstriction
8. Psychiatric illness or psychological problems, or deemed unsuitable on psychiatric
evaluation
9. Any condition that may prevent transplantation (positive cross match, high panel
reactive antibody (PRA), etc.)
10. Uncontrolled bleeding disorder, platelet count > 50,000, hemophilia or any other
inherited coagulopathy or need to routinely receive blood products for bleeding
disorders
11. Concurrent participation in any other clinical investigation during the period of this
investigation
12. Inability to undergo leukapheresis
13. Inability to participate in all necessary study activities due to physical or mental
limitations
14. Inability or unwillingness to return for all required follow-up visits.
15. Inability or unwillingness to sign the patient informed consent document.
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