Regeneration of Clinically Relevant Orofacial Tissues in Pre-Clinical Models

临床前模型中临床相关口面部组织的再生

基本信息

批准号：
7939746
负责人：
JEREMY J MAO
金额：
$ 103.75万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-25 至 2013-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7939746
关键词：
Address Adipose tissue Animal Model Animals Autologous Biological Bone Regeneration Bone Transplantation Cells Chemical Engineering Clinical Clinical Trials Communicable Diseases Complex Defect Dental General Practice Dental Implants Dental Pulp Dental Schools Dental caries Dentin Discipline Educational workshop Engineering Esthetics Excision Face Faculty Grant Head and Neck Surgery Healed Homing Human Implant In Vitro Infection Injury Knowledge Mechanics Mesenchymal Microscopic Molecular and Cellular Biology Morbidity - disease rate Natural regeneration Operative Surgical Procedures Oral Otolaryngology Outcome Pain Patients Phase Phenotype Plastics Polymers Pre-Clinical Model Procedures Proteins Reconstructive Surgical Procedures Regenerative Medicine Schools Science Scientist Series Site Stem cells Strategic Planning Structure Study Subject Surgeon Time Tissue Engineering Tissue Grafts Tissues Translations Trauma United States Universities Work analog base biocompatible polymer bone bone cell cellular engineering clinically relevant craniofacial design experience healing implantation in vivo interfacial medical schools member novel oral surgery specialty orofacial pre-clinical psychosocial public health relevance reconstruction regenerative research study restoration scaffold soft tissue stem stem cell biology tissue regeneration tumor

项目摘要

DESCRIPTION (provided by applicant): The face distinguishes one human being from another. When the face is disfigured from injuries, tumor resection, congenital anomalies or infectious diseases, the patient experiences both physical and psychosocial trauma, and therefore has strong desire for both functional and esthetic reconstruction. In the past decade, tissue engineering of orofacial structures has provided the proof of concept that single tissue fragments, such as dentin and bone, can regenerate in vitro or in small animal models. However, patients with dental pulp infection need the regeneration of both dentin and dental pulp; patients with deep facial defects can only be healed not only by the regeneration of bone, but also the overlaying, vascularized soft tissue that is attached to bone. We take advantage of the GO grant mechanism to assemble an existing critical mass of and well established scientists and multi-disciplinary surgeons into a consortium to regenerate dental pulp-dentin grafts and facial soft tissue-bone grafts in a pre-clinical, large animal model. Dental caries and trauma involving the dental pulp-dentin complex is the pillar of dental practice, with a current volume over 24 million procedures or ~30 billion dollars annually in the United States alone. Regenerated pulp-dentin grafts will transform this segment of dental practice. In parallel, biologically regenerated facial soft tissue-bone grafts will eliminate the need for autologous tissue grafting, and transform multiple clinical disciplines including Oral & Maxillofacial Surgery, Otolaryngology/Head and Neck Surgery, and Plastic and Reconstructive Surgery. Our existing multi-disciplinary expertise in stem cell biology, materials science, chemical engineering, mechanical engineering, cell and molecular biology, animal surgery and clinical knowledge will continue to advance the regeneration of clinically relevant orofacial tissues into Phase I human clinical trials upon the completion of the present two-year GO grant. With assistance of a FDA consultant who has previously worked with the PIs, we will plan for first-in- human clinical trials on dental pulp-dentin grafts and facial soft tissue-bone grafts in the present GO grant. PUBLIC HEALTH RELEVANCE: We take advantage of the GO grant mechanism to assemble an existing critical mass of well established scientists and multi-disciplinary surgeons into a consortium to regenerate dental pulp-dentin grafts and facial soft tissue-bone grafts in a pre-clinical, large animal model. With assistance of a FDA consultant who has previously worked with the PIs, we will plan for first-in-human clinical trials on dental pulp-dentin grafts and facial soft tissue-bone grafts in the present GO grant.

描述（由申请人提供）：面部将一个人与另一个人区分开。当面部被损伤，肿瘤切除，先天异常或感染性疾病毁容时，患者会遭受身体和社会心理创伤，因此对功能性和审美重建都有强烈的渴望。在过去的十年中，口面结构的组织工程提供了一个概念证明，即牙本质和骨骼等单个组织碎片可以在体外或小型动物模型中再生。但是，牙髓感染的患者需要牙本质和牙髓的再生。具有深层缺陷的患者不仅可以通过骨骼再生，还可以通过附着在骨骼上的叠加的血管化软组织来治愈。我们利用GO赠款机制来组装一个现有的临界质量，并建立了良好的科学家和多学科外科医生，以在一个临床前大型动物模型中再生牙髓牙髓丁物嫁接和面部软组织骨架再生。。涉及牙纸浆丁丁综合体的牙齿龋齿和创伤是牙科实践的支柱，仅在美国，目前的量超过2400万个程序，每年约300亿美元。再生的牙髓丁物移植物将改变这一牙齿实践的部分。同时，生物学上再生的面部软组织骨移植物将消除自体组织移植的需求，并改变多个临床学科，包括口腔和上颌面外科，耳鼻喉科/头颈外科手术，以及塑性和重建手术。我们现有在干细胞生物学，材料科学，化学工程，机械工程，细胞和分子生物学，动物外科和临床知识方面的多学科专业知识将继续在完成后将临床相关的口面组织的再生推向I期临床试验。目前的两年赠款。在以前曾与PIS合作的FDA顾问的协助下，我们将计划在本GO Grant中进行有关牙髓牙本质移植物和面部软组织骨移植的第一临床试验。公共卫生相关性：我们利用GO赠款机制，将现有的临界科学家和多学科外科医生组装到一个财团中，以在临床前的，前临床前的牙髓软组织移植物和面部软组织移植物中再生大动物模型。在以前曾与PIS合作的FDA顾问的协助下，我们将计划在目前的GO Grant中对牙髓牙本质移植物和面部软组织骨移植物进行首次人类临床试验。