Long-term function of vocal fold replacement in swine

退伍军人遭受损失的喉的声带覆盖由于创伤或 喉癌可能会导致发音困难，治疗方案包括 有限公司振动替代组织将彻底改变 喉部疾病本提案中所述的工作决定了长期的- 组织工程化细胞外声带长期安全性和有效性 更换（COVR）。从脂肪中分离的成人多能细胞 在纤维蛋白水凝胶内培养组织以产生三维组织 替身在植入家兔体内后，该结构愈合良好， 发声时的正常短期振动。 在人类翻译之前，需要一个大型动物模型。以前的工作 已经开发出了猪的移植方法。这项研究将 评估组织工程植入物在植入后1年内的长期安全性 植入将研究语音功能，以确定植入物是否可以恢复 声带损伤后的正常音质。完成拟议的研究 将确定COVR是否符合安全性和有效性要求， 继续向FDA申请人体试验

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.