Phase 1 Pilot Study of Bioengineered Penile Tissue Constructs in Subjects With Irreversibly Damaged Penile Corpora
Wake Forest University Health Sciences
Summary
The primary objective of this clinical trial is to evaluate the safety of autologous engineered corpora cavernosa + albuginea constructs for treatment of complex penile deformities. Autologous endothelial and smooth muscle cells obtained from enrolled subjects' corpora cavernosa biopsy sample, will be culture expanded in vitro and used to seed decellularized corpora cavernosa + albuginea obtained from cadaveric-donors to create autologous bioengineered corpora cavernosa/albuginea constructs for repair of damaged penile tissues.
Description
Damage to penile tissue due to infection, inflammation or trauma often leads to structural deformity that may result in loss of sexual function that can profoundly affect quality of life. Traumatic injuries in civilians and battlefield related injuries in soldiers often require reconstructive procedures to restore the anatomy and functionality of the penis. However, these procedures are often limited by poor availability of functionally intact penile tissue. Various penile reconstructive procedures, such as penile prostheses and autograft implantation have been attempted. While cosmetic appear…
Eligibility
- Age range
- 18–60 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Males aged 18-60 years. 2. Acquired structural abnormalities of the corpora cavernosum secondary to trauma, infection, inflammation, or fibromatosis. These abnormalities will be diagnosed by clinical examination, and/or ultrasound, and/or computerized tomography. 3. Stable abnormalities - at least 6 months with no pain or changes in deformity. 4. At least one failed attempt at management by conventional approaches at least 6 months prior to enrollment 5. Deformities less than 5 cm in length. 6. Written informed consent obtained prior to participation in the study. 7. Pa…
Interventions
- BiologicalAutologous tissue engineered corpora
penile tissue construct
Location
- Wake Forest Institute for Regenerative MedicineWinston-Salem, North Carolina