DEVELOPMENT OF SUTURELESS AMNIOTIC MEMBRANE GRAFT

描述（由申请人提供）：自从Pl在1995年的第一份报告中重新介绍了使用人保存羊膜进行眼表重建以来，越来越多的论文发表，证明了对其眼科应用的兴趣激增。总的来说，这些研究表明羊膜移植在促进上皮伤口愈合、减少基质炎症、疤痕和不必要的新血管形成方面是有效的。2001年，FDA正式将人羊膜归类为“组织”，而不是“设备”、“药物”或“生物制品”，用于眼表重建。使用Pl的专有方法（美国专利号6,152,142和6,326,019），Bio-Tissue, Tissue Tech, Inc.的子公司，自1997年以来，已经向美国700多名眼科医生分发了6000多块羊膜移植物（以AmnioGraft的商标名）。它们被用作永久性移植物或临时贴片（敷料或绷带）用于各种眼科适应症。在这两种应用模式中的任何一种中，缝合线用于在大手术室中将膜固定在患者的眼睛上。SBIR我拨款提案阶段的主要目标是开发一个“sutureless AmnioLens基于最近所有权(临时授权专利号: 60/365,356)。它将通过以下三个目标来实现。目标1：通过修改现有的原型来开发AminoLens，这些原型分别适合覆盖角膜和整个眼表面。目的2：检验人工羊膜在冷冻保存后的耐久性。目的3：探讨羊膜置换剂应用于兔眼的安全性（临床前研究）。上述三个目标的完成将为IDE提交给FDA提供足够的数据，以便在SBIR II期拨款的支持下启动临床试验。这一努力最终将导致AmnioLens的商业化，它可以用作临时贴片，即敷料或绷带，以治疗以伤口愈合不良、不必要的炎症和过度疤痕为特征的各种困难的眼表疾病。由于AmnioLens是“无缝合线”的，它可以用于办公室实践或烧伤或重症监护病房的床边，以消除繁琐和昂贵的手术设施。此外，它还将允许我们在未来测试其在其他临床适应症中的适用性。

DESCRIPTION (provided by applicant): Ever since Pl's first report in 1995 to reintroduce the use of human preserved amniotic membrane for ocular surface reconstruction, there has been a surge of interest in its ophthalmic uses as evidenced by the increasing numbers of papers published. Collectively, these studies have shown that amniotic membrane transplantation is effective in facilitating epithelial wound healing, and reducing stromal inflammation, scarring and unwanted new blood vessel formation. In 2001, FDA has formally classified human amniotic membrane as a "Tissue" and not "Device" or "Drug" or "Biologics" when used for ocular surface reconstruction. Using Pl's proprietary method (US Patents Nos. 6,152,142 and 6,326,019), Bio-Tissue, a subsidiary of Tissue Tech, Inc., has distributed more than 6000 amniotic membrane grafts (under the trade name of AmnioGraft) to more than 700 ophthalmic surgeons In USA since 1997. They were used as a permanent graft or as a temporary patch (dressing or bandage) for a variety of ophthalmic indications. In either of these two modes of applications, sutures are used to secure the membrane on patient's eye at a major operating room. The main objective of this SBIR Phase I grant proposal is to develop a "sutureless" AmnioLens based on a recently licensed proprietary right (Provisional Patent No.: 60/365,356). It will be accomplished by the following three Aims. Aim 1: To develop AminoLens by modifying the existing prototypes based on the shape of a conformer to be fitted to cover the corneal and the entire ocular surfaces, respectively. Aim 2: To examine the durability of the manufactured AmnioLens after cryopreservation. Aim 3: To examine the safety of AmnioLens when applied to rabbit eyes (pre-clinical study). Completion of the above three aims will generate sufficient data for IDE submission to FDA so that a clinical trial can be initiated under the support of SBIR Phase II grant. This endeavor will ultimately lead to the commercialization of AmnioLens that can be used as a temporary patch, i.e., dressing or bandage, to treat various difficult ocular surface diseases characterized by poor wound healing, unwanted inflammation and excessive scarring. Because AmnioLens is "sutureless", it can be used in office practices or bedside of Burn or Intensive Care Units to eliminate cumbersome and costly surgical facilities. Furthermore, it will also allow us to test its applicability in other clinical indications in the future.