Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora
Phase 1 Pilot Study of Bioengineered Penile Tissue Constructs in Subjects With Irreversibly Damaged Penile Corpora
Wake Forest Institute for Regenerative Medicine researchers need patients with penile structural deformity caused by infection, inflammation, or trauma with defect to the corpora cavernosa, to trial a tissue engineering-based therapy for reconstruction. This clinical trial will evaluate the safety of autologous engineered tissue constructs engineered from the patient’s own (autologous) endothelial and smooth muscle cells, culture-expanded in the lab, and used to seed a decellularized scaffold from cadaveric donors to create autologous bioengineered corpora cavernosa/albuginea constructs for repair of damaged penile tissues. By using only the scaffold of the donor and the patient’s own cells to build the tissue graft, no rejection is predicted.
The treatment will require an outpatient biopsy, from which the necessary cells will be isolated in the lab, multiplied and grown within the donor scaffold until prepared for surgical transplantation. Participants will be followed through 36 months post-implantation to monitor for safety.
- Be 18 to 60 years of age
- Have acquired structural abnormalities of the corpora cavernosum secondary to trauma, infection, inflammation, or fibromatosis, that are stable (at least 6 months with no pain or changes in deformity) and less than 5 cm in length
- Have at least one failed attempt at management by conventional approaches at least 6 months prior to enrollment
THE STUDY INVOLVES:
- Screening to confirm acceptance to the study.
- Enrolled participants will undergo a corporal tissue biopsy as an out-patient surgical procedure.
- Lab-only: Autologous corporal smooth muscle cells and corporal endothelial cells will be isolated and then seeded on cadaveric decellularized corporal bodies.
- Approximately 3-4 weeks later, the engineered construct including corporal tissue with attached tunica will be transplanted into the surgically prepared site of penile injury.
- Participants will be followed through 36 months post-implantation to monitor for safety.
LOCATIONS & CONTACTS:
Trials will take place at the Wake Forest Institute for Regenerative Medicine in Winston-Salem, NC. Map.
Mary-Clare Day, RN, BSN | 336-713-1343 | [email protected]
Wake Forest University Health Sciences
United States Department of Defense
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