Long-term function of vocal fold replacement in swine

猪声带置换的长期功能

• 批准号: 10742917
• 负责人: Jennifer L Long
• 金额: --
• 依托单位: VA GREATER LOS ANGELES HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-01 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10742917
• 关键词: 3-Dimensional; Acoustics; Adipose tissue; Adult; Adverse event; Animal Model; Animals; Autopsy; Bilateral; Cell Separation; Cells; Chemicals; Chronic; Cicatrix; Collagen Fiber; Communication impairment; Data; Data Collection; Deposition; Desmosine; Development; Elastic Fiber; Emotional; Excision; Extracellular Matrix; Family suidae; Fatigue; Female; Fibrin; Fibrosis; Frequencies; Gastroesophageal reflux disease; Goals; Head and Neck Cancer; Histologic; Human; Hydrogels; Hydroxyproline; Immunocompetent; Impairment; Implant; Implantation procedure; Inhalation; Injury; Laboratories; Laryngeal Diseases; Larynx; Laser Scanning Microscopy; Link; Malignant neoplasm of larynx; Mammals; Measurement; Measures; Mechanics; Methods; Miniature Swine; Modeling; Morphology; Occupational; Occupations; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Periodicals; Phonation; Pilot Projects; Postoperative Period; Proteins; Proteomics; Radiation therapy; Recovery; Regenerative Medicine; Research; Safety; Sampling; Serum; Smoke; Social Interaction; Speed; Structure; Testing; Tissue Engineering; Tissues; Translations; Trauma; Urine; Veterans; Voice; Voice Disturbances; Voice Quality; Work; efficacy testing; experience; functional restoration; healing; implantation; improved; in vivo; injured; male; mechanical behavior; mechanical properties; mesenchymal stromal cell; multipotent cell; repaired; replacement tissue; restoration; scaffold; smoke inhalation; social; sound; tissue culture; vibration; vocal cord; wound healing

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.

因创伤或其他原因导致喉部声带盖丧失的退伍军人 喉癌可能会导致发音困难，治疗方案包括 有限的。一种振动的替代组织将彻底改变治疗 喉部疾病。本提案中描述的工作确定了长期的-- 组织工程细胞构建的外声带的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 组织在纤维蛋白水凝胶中培养，以产生三维组织 替身。在兔体内植入后，这种结构愈合良好，并产生了 发声的正常短期振动。 在人类翻译之前，需要一个大型动物模型。以前的工作 已经开发出在猪身上植入的方法。这项拟议的研究将 1年后评估组织工程植入物的长期安全性 植入。将对语音功能进行研究，以确定种植体是否可以恢复 声带损伤后嗓音质量正常。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FDA的人体试验申请。