Bioengineered Penile Tissue for Penile Damage
Trial Summary
Do I need to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressive agents, you may not be eligible to participate.
What data supports the effectiveness of the treatment Autologous Tissue Engineered Corpora for penile damage?
Is bioengineered penile tissue safe for use in humans?
Research on bioengineered penile tissue, primarily conducted in animal models like rabbits, shows promising safety results, with no signs of immunological rejection and good compatibility with existing tissues. These studies suggest that the technology could be safe for penile reconstruction, but more research in humans is needed to confirm this.12367
How is the treatment Autologous Tissue Engineered Corpora different from other treatments for penile damage?
This treatment is unique because it uses bioengineered penile tissue created from the patient's own cells, which are grown on a collagen matrix to replace damaged penile tissue. Unlike traditional implants, this approach aims to restore both the structure and function of the penis, potentially allowing for normal reproductive, sexual, and urinary functions.12358
What is the purpose of this trial?
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.
Research Team
Ryan P Terlecki, MD
Principal Investigator
Associate Professor
Eligibility Criteria
Men aged 18-60 with stable penile deformities due to trauma, infection, or other causes who've unsuccessfully tried conventional treatments. They must be healthy enough for surgery, not have severe bleeding disorders or unstable heart conditions, and can't be immunocompromised or have certain infections like HIV.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Biopsy and Cell Expansion
Participants undergo a corpora cavernosum biopsy to obtain endothelial and smooth muscle cells, which are then culture expanded in vitro.
Transplantation
The engineered construct, including corporal tissue with attached tunica, is transplanted into the surgically prepared site of penile injury.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including monitoring for graft thrombosis or failure and treatment-related adverse events.
Treatment Details
Interventions
- Autologous Tissue Engineered Corpora
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
United States Department of Defense
Collaborator