Veterans suffering loss of the larynx's vocal fold cover due to trauma or laryngeal cancer can suffer disabling voice difficulties, and treatment options are limited. A vibrating replacement tissue would revolutionize the treatment of laryngeal disorders. The work described in this proposal determines the long- term safety and efficacy of a tissue-engineered Cell-based Outer Vocal cord Replacement (COVR). Adult human multipotent cells isolated from adipose tissue are cultured within fibrin hydrogel to produce a three-dimensional tissue substitute. Upon implantation in rabbits, this construct healed well and produced normal short-term vibration for voicing. A large animal model is needed before human translation. Previous work has developed the implantation method in pigs. This proposed research will assess the long-term safety of the tissue-engineered implant up to 1 year after implant. Voice function will be studied to determine if the implant can restore normal voice quality after vocal cord injury. Completion of the proposed research will determine whether the COVR meets safety and efficacy requirements to proceed with FDA application for a human trial.

Vocal folds are the vibrating parts of the human larynx that produce voice. Vocal folds can be damaged from a number of injuries, including surgeries for laryngeal cancer or non-cancerous masses, radiation therapy for other head and neck cancers, smoke or chemical inhalation injuries, and chronic severe acid reflux. Once the vocal folds are scarred, there is little that can be done to restore their vibration. Veterans with vocal fold injuries can suffer disabling voice difficulties with poor voice quality and vocal fatigue. The communication impairment limits social interactions and job opportunities. This project aims to develop an implantable vibrating replacement tissue to restore voice for these Veterans.