Bioengineered Penile Tissue for Penile Damage
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for men with specific penile deformities caused by trauma, infection, or other medical issues. The treatment, called Autologous Tissue Engineered Corpora, uses a patient's own cells to create bioengineered tissue to repair damaged areas. The main goal is to ensure the safety of this new approach. Men with stable penile deformities for at least six months who have not found success with standard treatments might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this innovative treatment, aiding researchers in understanding its effects in people.
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 prior data suggests that this bioengineered tissue is safe for penile repair?
Research shows that using specially grown tissue for rebuilding the penis appears promising. Studies have focused on restoring parts of the penis to improve function, and so far, they have not identified any serious safety issues.
In this trial, the tissue is made from a person's own cells, reducing the likelihood of rejection. It is akin to using a piece of one's own body to repair another part.
Previous research on similar techniques suggests that the process can be safe. However, this trial is in the early stages, with the primary goal of ensuring safety for humans. Early trials often prioritize safety before assessing effectiveness.
In summary, early results suggest that this tissue engineering method is generally well-tolerated. However, more research is needed to fully understand its safety.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for penile damage, which often involve surgical reconstruction or prosthetic implants, the autologous tissue engineered corpora approach harnesses the patient’s own cells. Researchers are excited because this method uses a bioengineered scaffold seeded with the patient’s own endothelial and smooth muscle cells, aiming for a more natural integration and function. This technique could potentially improve outcomes by promoting tissue regeneration rather than just mechanical repair, offering a more personalized and potentially longer-lasting solution.
What evidence suggests that this bioengineered tissue is effective for penile damage?
Research has shown that lab-grown penile tissue could repair damaged areas. In this trial, participants will receive autologous tissue-engineered corpora, using their own cells to create replacement tissues. Studies have found that these lab-created tissues, known as neocorpora, can replace damaged parts and restore function. In tests with rabbits, scientists successfully used these engineered tissues to replace parts of the penis, suggesting this method might work for humans too. The aim is to use a person's own cells to create these replacement tissues, potentially lowering the risk of rejection and improving healing. Although still in the early stages, this research suggests that this method could effectively treat complex penile deformities.14678
Who Is on the Research Team?
Ryan P Terlecki, MD
Principal Investigator
Associate Professor
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
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