A Biomaterial for Esophageal Repair

用于食管修复的生物材料

• 批准号: 6655721
• 负责人: Alan Robert Spievack
• 金额: $ 26.24万
• 依托单位: ACELL, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-01 至 2004-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6655721
• 关键词: biodegradable product; biomaterial development /preparation; biomaterial evaluation; dogs; esophagus; esophagus disorder; esophagus motility /pressure; extracellular matrix; tissue engineering; tissue support frame; urinary bladder epithelium

DESCRIPTION (provided by applicant): ACell is a tissue engineering company and its core technology is based upon a porcine derived extracellular matrix (ECM) harvested from the urinary bladder (UBM) that serves as a constructive scaffold for tissue reconstruction. Successful completion of Phase I studies showed that the UBM-ECM can be configured into a tube shaped device with mechanical and material properties suitable for the repair of esophageal tissue. These studies also showed that primary canine esophageal epithelial cells could attach, proliferate and differentiate in vitro upon the UBM scaffold. Finally, a preliminary study in a dog model demonstrated the ability of the resorbable UBM scaffold to replace native esophageal tissue with host derived tissues that included an intact squamous epithelium, submucosal vascularized collagenous tissue and subjacent bundles of skeletal muscle appropriate for the resected segment of cervical esophagus. The present Phase II SBIR proposal seeks support to pursue the development of the UBM bioscaffold as a device for the repair or replacement of damaged or missing esophageal tissue; a surgical application that currently has very limited options. There are three studies described, each of which addresses a clearly defined specific aim: (1) to determine the fate and mode of degradation of the porcine derived UBM scaffold when used as an esophageal repair device in a dog model; (2) to complete ISO-9001 testing as a prerequisite to regulatory submission of an Investigational Device Exemption (DE); and (3) to examine the safety and efficacy of the UBM device in a definitive chronic study using an animal model. The work will be conducted by an experienced interdisciplinary group of investigators and will combine the expertise of ACell's professional staff, the certified laboratories of the North America Science Associates (NamSA), and a university partner. A timeline for completion of the studies, clearly defined criteria for success, and plans for subsequent Phase III work are included in this Phase II proposal. PROPOSED COMMERCIAL APPLICATION: Congenital and acquired abnormalities of the esophagus present surgical challenges with extremely limited options. Morbidity associated with surgical procedures is significant. Stricture of the esophagus following either injury or replacement of damaged tissues by existing biomaterials is a significant problem. Esophageal adenocarcinoma has increased in incidence by 350% since the mid-1970's. Since this is a clinical area withe virtually no biomaterial options, the successful completion of this SBIR application addresses a significant unmet clinical need.

描述（由申请人提供）：ACell 是一家组织工程公司，其核心技术基于从猪膀胱 (UBM) 中采集的细胞外基质 (ECM)，作为组织重建的构建支架。第一阶段研究的成功完成表明，UBM-ECM可以配置成具有适合食管组织修复的机械和材料特性的管状装置。这些研究还表明，原代犬食管上皮细胞可以在体外在 UBM 支架上附着、增殖和分化。最后，在狗模型中进行的一项初步研究表明，可吸收的 UBM 支架能够用宿主衍生的组织替代天然食管组织，这些组织包括完整的鳞状上皮、粘膜下血管化胶原组织和适合颈椎切除段的下层骨骼肌束。食管。目前的第二阶段 SBIR 提案寻求支持，以开发 UBM 生物支架作为修复或替换受损或缺失食管组织的装置；目前选择非常有限的外科手术应用。描述了三项研究，每项研究都有一个明确定义的具体目标：（1）确定猪源 UBM 支架在狗模型中用作食管修复装置时的命运和降解模式； (2) 完成 ISO-9001 测试，作为向监管机构提交研究器械豁免 (DE) 的先决条件； (3) 在使用动物模型的明确慢性研究中检查 UBM 装置的安全性和有效性。这项工作将由经验丰富的跨学科研究小组进行，并将结合 ACell 专业人员、北美科学协会 (NamSA) 认证实验室和大学合作伙伴的专业知识。该第二阶段提案中包括完成研究的时间表、明确定义的成功标准以及后续第三阶段工作的计划。 拟议的商业应用：先天性和后天性食管异常给手术带来了挑战，选择极其有限。 与外科手术相关的发病率是显着的。 受伤或用现有生物材料替换受损组织后食道狭窄是一个重大问题。 自 20 世纪 70 年代中期以来，食管腺癌的发病率增加了 350%。由于这是一个几乎没有生物材料选择的临床领域，因此 SBIR 应用的成功完成解决了重大的未满足的临床需求。