DEVELOPMENT OF AN ARG-GLY-ASP-BASED WOUND HEALING AGENT

基于 ARG-GLY-ASP 的伤口愈合剂的开发

• 批准号: 3507951
• 负责人: JAMES W POLAREK
• 金额: $ 6.2万
• 依托单位: TELIOS PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-06-01 至 1992-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3507951
• 关键词: biomaterial evaluation; burn therapy; burns; cell migration; chemical conjugate; clinical trials; collagen; decubitus ulcer; extracellular matrix; extracellular matrix proteins; fibroblasts; fibronectins; gel; human subject; human therapy evaluation; neoplasm /cancer surgery; peptide chemical synthesis; polymers; protein sequence; surgical wound; wound healing

We propose to carry out clinical safety and efficacy studies on the arg-gly-asp-containing wound healing agent developed under our Phase I grant. This product has been shown to be effective in the improvement of healing of several in vivo wound healing models, and has been found to be non-toxic, non-mutagenic and nonimmunogenic by the same criteria. We therefore propose to test this compound's safety in limited human clinical trials. After establishing the safety of the human use of the product, we will begin small (18 patient) trials into the effectiveness of the use of the product in the treatment of severe burns, chronic ulcers caused by vascular insufficiency, and the wounds resulting from the surgical incision of skin cancers. We also propose to carry out experiments leading to the efficient scale up of the production of the materials.

我们建议进行临床安全性和有效性研究， 在我们的I期研究中开发的含arg-gly-asp的伤口愈合剂 格兰特.该产品已被证明是有效的改善 几种体内伤口愈合模型的愈合，并且已经发现 按照相同的标准，无毒、无致突变性和无免疫原性。我们 因此，建议在有限的人类临床试验中测试该化合物的安全性， 审判在确定产品的人类使用安全性后，我们 将开始小规模（18名患者）试验， 本品用于治疗严重烧伤、慢性溃疡引起的 血管功能不全以及手术切口造成的伤口 皮肤癌。我们还建议进行实验， 材料生产的有效规模化。