SBIR Phase I: Creation of antimicrobial MyoMatrix for functional muscle regeneration in a porcine model of volumetric muscle loss

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是将一种抗菌肌肉再生生物材料开发成商业就绪的产品，并解决容积性肌肉损伤问题。在国防医学的背景下，严重的肌肉损伤往往发生在不孕不育等外部因素没有得到很好控制的环境中。该项目预计将展示这种新型肌肉再生生物材料的抗微生物特性，使其能够在这些环境中使用。如果成功，抗菌肌肉再生生物材料的更广泛的社会和经济影响是惊人的。容积性肌肉丧失每年影响数千万名受害者。60%的患者没有得到治疗，30%的患者接受了肌瓣移植，10%的受伤肢体被截肢。截肢的总平均终生成本现在总计超过70万美元。这项技术的实施带来的临床结果的改善可能会在每个接受者的一生中节省数十万美元。这个小企业创新研究(SBIR)第一阶段项目展示了相对于目前尚不存在治疗方法的容积性肌肉损失的现有护理标准的重大进步。细胞和细胞外基质的联合丢失创造了一个肌肉再生无法发生的环境，导致肌肉随着时间的推移而崩溃和萎缩。该项目有效地替代了在体积肌肉损失中丢失的细胞外基质，并创造了卫星细胞可以增殖和分化为新的肌肉组织的环境。临床医生，特别是那些在严酷的军事环境中工作的医生提出的一个技术问题是，将异物植入伤口床会导致感染的风险。为了解决这一问题，技术目标1将重点放在加入抗菌剂以优化支架的能力，以促进肌肉再生，同时具有抗菌效果。将评估结构和机械性能，确保细胞活性，评估肌肉细胞质量，并测量抗菌性能。技术目标2旨在通过一个实验性的猪肌肉创伤模型来研究这些结果。预计建议的抗菌生物材料将既对抗感染风险，又有效地再生创伤性肌肉损伤的功能肌肉。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop an antimicrobial muscle-regenerating biomaterial into a commercial-ready product and address volumetric muscle loss injuries. In the context of defense medicine, severe muscle trauma often occurs in environments where external factors such as sterility are not well-controlled. This project is expected to demonstrate antimicrobial properties of this novel muscle-regenerating biomaterial to enable use in these environments. If successful, the broader societal and economic impacts of antimicrobial muscle-regenerating biomaterials are staggering. Volumetric muscle loss affects tens of millions of victims each year. Sixty percent of patients are left untreated, 30% receive a muscle flap transplant, and 10% of injured limbs are amputated. Total average lifetime costs for amputation now total over $700,000. Improved clinical outcomes resulting from the implementation of this technology could lead to hundreds of thousands of dollars in savings over the course of each recipient's lifetime.This Small Business Innovation Research (SBIR) Phase I project demonstrates significant advances over the existing standard of care for the treatment of volumetric muscle loss, for which no treatment currently exists. The joint loss of cells and extracellular matrix creates an environment where muscle regeneration cannot occur, leading to muscle collapse and atrophy over time. This project effectively replaces the extracellular matrix lost in volumetric muscle loss and creates an environment where satellite cells may proliferate and differentiate into new muscle tissue. A technical concern raised by clinicians, especially those who work in austere environments in military medicine, is the risk of infection caused by implanting a foreign substance into a wound bed. To address this, Technical Objective 1 will focus on incorporating antibacterial agents to optimize the scaffold’s ability to promote muscle regeneration while also having an antibacterial effect. Structural and mechanical properties will be assessed, cellular viability ensured, muscle cell quality evaluated, and antibacterial properties measured. Technical Objective 2 aims to investigate these outcomes with a pilot porcine model of muscle trauma. It is anticipated that the proposed antimicrobial biomaterial will both combat the risk of infection and effectively regenerate functional muscle in traumatic muscle injuries.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.