Status:
WITHDRAWN
Human Penile Tissue Allotransplantation for Devastating Penile and Concomitant Genital Trauma
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Urologic Injuries
Genital Diseases, Male
Eligibility:
MALE
18-35 years
Phase:
PHASE1
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 allotr...
Detailed Description
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 exis...
Eligibility Criteria
Inclusion
- For Recipients
- Male
- 18-40 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
Exclusion
- For Recipients
- 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
- urethral stricture disease
- balanitis
- xerotica obliterans
- pelvic embolization
- pelvic radiation
- untreated hypogonadism
- prior prostate surgery
- recurrent urinary tract infections (UTIs)
- nephrolithiasis
- connective tissue disease or collagen disease
- lipopolysaccharidosis or amyloidosis
- Use of 5-alpha-reductase inhibitors
- External signs, sequelae or positive serology of sexually transmitted disease (including HPV)
- Active UTI, stones, urethral edema and other pathology that prevents urethral anastomosis
- Current or past substance abuse
- Current or past smoker (within past 3 months)
- Use of any medications known to cause vasoconstriction
- Psychiatric illness or psychological problems, or deemed unsuitable on psychiatric evaluation
- Any condition that may prevent transplantation (positive cross match, high panel reactive antibody (PRA), etc.)
- Uncontrolled bleeding disorder, platelet count \> 50,000, hemophilia or any other inherited coagulopathy or need to routinely receive blood products for bleeding disorders
- Concurrent participation in any other clinical investigation during the period of this investigation
- Inability to undergo leukapheresis
- Inability to participate in all necessary study activities due to physical or mental limitations
- Inability or unwillingness to return for all required follow-up visits.
- Inability or unwillingness to sign the patient informed consent document.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03240822
Start Date
January 1 2017
End Date
December 1 2025
Last Update
April 14 2021
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