A BIOMATERIAL FOR ESOPHAGEAL REPAIR

用于食管修复的生物材料

• 批准号: 6292755
• 负责人: Alan Robert Spievack
• 金额: $ 10万
• 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 2001-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6292755
• 关键词: biodegradable product; biomaterial development /preparation; biomaterial evaluation; dogs; esophagus; esophagus motility /pressure; extracellular matrix; tissue engineering; tissue support frame; urinary bladder epithelium

DESCRIPTION (Verbatim from the Applicant's Abstract): This Phase I SBIR application seeks support to develop and evaluate the use of an extracellular matrix (ECM) bioscaffold derived from the urinary bladder-extracellular matrix (UBM) for the repair and reconstruction of diseased esophageal tissue. Porcine-derived UBM represents an acellular biodegradable scaffold material that supports cell attachment, migration, proliferation, differentiation, and tissue remodeling. The hydrated form of single sheets of UBM and other ECMs have shown excellent remodeling capabilities in both preclinical animal studies and human clinical studies for applications unrelated to the gastrointestinal tract. We propose to conduct three studies. Study #1 will establish manufacturing methods for a multilaminate sheet of UBM that has defined mechanical properties sufficient for esophageal repair. Study #2 will evaluate the ability of a multilaminate UBM sheet to support primary esophageal epithelial cell growth in vitro. Study #3 will utilize the prototype multilaminate UBM device in a preliminary dog study in which a full circumference segmental esophageal defect will be repaired. Currently, there are no viable options for a biomaterial to replace esophageal tissue. Esophageal stricture, and lack of esophageal motility are serious limitations to existing biomaterial alternatives for this application. As location of autologous stomach or bowel account for a majority of existing surgical techniques for the repair or reconstruction of segments of the esophagus at the present time. Successful completion of the three specific aims defined for this Phase I project will provide the necessary information to decide whether or not this UBM scaffold should be evaluated further as a biomaterial for esophageal repair. Each objective/specific aim has well-defined endpoints and criteria for success. An experienced and knowledgeable research team will conduct the proposed studies and time line for the proposed work is provided. This technology provides an innovative tissue engineering approach in a medical field with significant unmet needs. 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 tissue 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 with virtually no biomaterial options, the successful completion of this SBIR application addresses a significant unmet clinical need.

描述（逐字摘自申请人摘要）：第一阶段 SBIR 申请寻求支持来开发和评估细胞外的使用 源自膀胱细胞外基质的基质（ECM）生物支架 (UBM) 用于修复和重建患病食管组织。 猪源 UBM 是一种无细胞生物可降解支架材料 支持细胞附着、迁移、增殖、分化和 组织重塑。单片 UBM 和其他 ECM 的水合形式 在两项临床前动物研究中都表现出了出色的重塑能力 和与胃肠道无关的应用的人体临床研究 道。我们建议进行三项研究。研究#1 将建立 UBM 多层板的制造方法已定义 机械性能足以修复食管。研究#2 将评估 多层 UBM 片支撑原发食管的能力 上皮细胞体外生长。研究 #3 将利用原型 在一项初步的狗研究中使用了多层 UBM 装置，其中完整的 圆周节段性食管缺损将被修复。目前，有 没有可行的生物材料替代食管组织的选择。 食管狭窄和食管动力不足是严重的限制 用于此应用的现有生物材料替代品。作为位置 自体胃或肠占现有手术的大部分 修复或重建食管段的技术 现在的时间。圆满完成本次会议确定的三个具体目标 第一阶段项目将提供必要的信息来决定是否 这种 UBM 支架应作为食管生物材料进行进一步评估 维修。每个目标/具体目标都有明确定义的终点和标准 成功。经验丰富且知识渊博的研究团队将进行 提供了拟议的研究和拟议工作的时间表。这 技术为医疗领域提供了一种创新的组织工程方法 存在重大未满足需求的领域。 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 选项极为有限。 与外科手术相关的发病率是显着的。 狭窄 受伤或用现有的替代受损组织后的食道 生物材料是一个重大问题。 食管腺癌发病率增加 自 1970 年代中期以来增长了 350%。 由于这是一个几乎没有生物材料选择的临床领域， 该 SBIR 申请的成功完成解决了重大的未满足的临床需求。