Modified Cotton Dressings for Treating Chronic Wounds

开发临床上有效的慢性伤口治疗方法是非常有必要的。据估计，治疗慢性伤口的费用每年高达数十亿美元。随着西方社会继续老龄化，慢性创伤的问题可能会增加。最近的研究表明，在过度活跃的中性粒细胞反应中释放的蛋白水解酶可能在慢性创面的病理生理学中发挥重要作用。这项拟议研究的目的是测试设计和开发具有隔离/抑制中性粒细胞衍生的蛋白酶能力的敷料的可行性。重点将放在改性纤维素基材料的利用上。以纤维为基础的材料将被改进，以引入功能模式，预计将结合中性粒细胞弹性蛋白酶和可能的其他阳离子中性粒细胞衍生的蛋白酶。体外试验将被用来评估几种改良产品从伤口液中去除蛋白水解物的能力。具有所需隔离性能的候选材料将进一步检查pH稳定性、灭菌稳定性和细胞毒性。除了合理的战略基础外，这种改性的纤维素基材料还有一个额外的优势，即相对便宜，因此在全球市场上有很大的使用潜力。一旦这一原理在一种简单的纤维素敷料上得到证明，将进行实验，以扩大其他更复杂的基质用作敷料材料的潜力(正在申请专利)，并扩大隔离/抑制化合物在敷料上或以软膏霜乳液的形式使用的范围。拟议的商业应用：治疗慢性伤口的总成本估计为220-260亿美元(第11页)，所用敷料的成本超过10亿美元(第13页)。与目前可用的伤口护理产品和正在开发的产品相比，这项技术具有以下重大优势：非侵入性治疗方法；低制造成本；进入第三世界市场的潜力，并为这一通常被忽视的人群带来负担得起的医疗保健；临床性能与每管300美元的药物增长因素相当。这一组独特的因素加在一起，使其在美国的销售潜力估计为9500万美元，在全球范围内是这个数字的三倍。

There is an immense need for developing clinically effective treatments of chronic wounds. Estimates of the costs for treating chronic wounds range into the billions of dollars annually. As Western society continues to age, the problem of chronic wounds will likely increase. Recent studies indicate proteases released during an over exuberant neutrophil response may have a significant role in the pathophysiology of chronic wounds. The objective of this proposed study is to test the feasibility of designing and developing dressings with the ability to sequestered/inhibit neutrophil derived proteases. Focus will be on the utilization of modified cellulosic-based materials. Cellulosic-based materials will be modified so as to introduce functional modalities that are predicted to bind neutrophil elastase and possibly other cationic neutrophil-derived proteases. In vitro assays will be used to assess the ability of several modified products to remove proteolytic activities from wound fluids. Candidate materials with desired sequestering properties will e further examined for pH stability, sterilization stability, and cytotoxicity. Besides their basis on a rational strategy, such a modified cellulosic-based material will have the additional advantage of being relatively inexpensive and thus have a high potential for use in the world-wide market. Once the principle has proved on a simple cellulosic dressing material, experiments will be conducted to expand the potential for other more sophisticated substrates for use as dressing materials (patents pending) and expanding the range of sequestering/inhibiting compounds onto the dressing or in the form of an ointment cream lotion. PROPOSED COMMERCIAL APPLICATIONS: The total cost for treating chronic wound sis estimated at $22-26 bn (Page 11), the cost of dressings used is in excess of $1 bn (Page 13). When compared with both currently available wound care products and those in development the technology has the following significant advantage: non invasive method of treatment; low cost of manufacture; potential to enter the 3rd world markets and bring affordable health care to this normally overlooked segment of the population; comparable clinical performance to the pharmaceutical growth factors that are priced at $300 per tube. This unique set of factors combine to offer a sales potential estimated at $95MM in the US and triple that number worldwide.