SBIR Phase I: Cure-in-Place Extracellular Matrix Replacement Scaffolds for Wound Healing

第一阶段SBIR项目将研究用于填充和稳定开放性伤口以促进愈合的原位固化材料。慢性伤口对患者来说是一个重大的和使人衰弱的负担，仅在美国就影响了650多万人。预计慢性伤口的发生率将随着肥胖和糖尿病的发病率增加而增加，但目前的治疗方案显示出有限的临床疗效。为了解决这一未满足的需求，必须开发刺激身体愈合机制的新材料。该项目将评估一种有前途的新材料，该材料可以作为液体应用于伤口，并在与伤口接触时固化为固体。预期这种原位固化过程通过确保促愈合材料与伤口床之间的紧密接触、机械稳定伤口区域以及刺激身体的愈合反应来促进愈合。临床使用的原位固化材料很少，因此该项目还将产生有关这些材料及其在人类健康中的潜在应用的新的基础工程知识。先进的伤口护理市场目前价值超过80亿美元，而且还在增长。因此，该领域的创新技术代表着创造经济增长的重要商机。本项目将研究一种新型原位固化工艺，用于生成模拟天然细胞外基质的机械和结构特性的多糖生物材料，以刺激伤口愈合。该材料通过固化两种水性前体溶液以形成可生物降解的固体水合聚合物基质而产生。本项目将研究一种就地治疗方法，通过该方法，前体溶液将以液体形式应用于伤口，并在与伤口床接触时固化。如果细胞外基质替代生物材料可以在伤口床内部固化，则其促愈合作用可以由于其填充不规则形状的伤口并与组织完全接触的能力以及其机械稳定伤口床和刺激促愈合生物化学的能力而放大。这项工作的范围将包括开发原位固化前体溶液的优化配方，确定与组织接触的生物材料的固化条件，评估原位固化产品的材料特性，和评估治疗，该奖项反映了NSF的法定使命，并通过评估被认为值得支持使用基金会的知识价值和更广泛的影响审查标准。

This Phase I SBIR project will investigate cure-in-place materials for filling and stabilizing open wounds to promote healing. Chronic wounds represent a significant and debilitating burden to patients, affecting more than 6.5 million people in the US alone. The incidence of chronic wounds is expected to rise with increasing rates of obesity and diabetes, but current treatment options show limited clinical efficacy. To address this unmet need, new materials that stimulate the body's healing mechanisms must be developed. This project will evaluate a promising new material that can be applied to a wound as a liquid and cured to a solid in contact with the wound. This cure-in-place process is expected to promote healing by ensuring intimate contact between the pro-healing material and the wound bed, mechanically stabilizing the wound area, and stimulating the body's healing responses. There are few cure-in-place materials in clinical use, so this project will also generate new fundamental engineering knowledge about these materials and their potential applications in human health. The advanced wound care market is currently valued at more than $8 billion, and it is growing. Therefore, innovative technologies in this space represent significant business opportunities that create economic growth.This project will investigate a novel cure-in-place process for generating a polysaccharide biomaterial that mimics the mechanical and structural properties of native extracellular matrix to stimulate wound healing. The material is generated by curing two aqueous precursor solutions to form a biodegradable, solid, and hydrated polymer matrix. This project will investigate a cure-in-place process by which the precursor solutions will be applied to the wound as liquids and cured in contact with the wound bed. If the extracellular matrix replacement biomaterial can be cured inside of a wound bed, then its pro-healing effects may be amplified due to its ability to fill an irregularly-shaped wound with complete contact with tissue and its capacity to mechanically stabilize the wound bed and stimulate pro-healing biochemistry. The scope of this effort will include developing an optimized formulation for the cure-in-place precursor solution, determining curing conditions for the biomaterial in contact with tissue, evaluating the material properties of the cure-in-place product, and evaluating cure-in-place application and wound healing efficacy in a porcine excisional wound model.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.