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Autologous tissue engineered corpora is an investigational regenerative medicine therapy developed by Wake Forest University Health Sciences for the treatment of complex penile deformities and irreversible damage to the penile corpora. The therapy involves a multi-step bioengineering process: first, endothelial and smooth muscle cells are harvested from the patient's own corpora cavernosa via biopsy; these cells are then expanded in vitro. The expanded autologous cells are seeded onto decellularized corpora cavernosa and tunica albuginea scaffolds obtained from cadaveric donors. This process creates a bioengineered construct designed to be surgically implanted into the patient to replace damaged tissue, restore structural integrity, and potentially recover erectile function. It is currently being evaluated in a Phase 1 clinical trial (NCT03463239) for safety in men with severe penile tissue damage resulting from trauma, infection, or other conditions.
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