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

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是将抗菌肌肉再生生物材料开发成商业产品，并解决体积性肌肉损失损伤。在防御医学的背景下，严重的肌肉创伤往往发生在无菌等外部因素控制不好的环境中。该项目有望证明这种新型肌肉再生生物材料的抗菌性能，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广泛社会和经济影响是惊人的。体积性肌肉损失每年影响数千万受害者。60%的患者没有得到治疗，30%的患者接受了肌肉瓣移植，10%的受伤肢体被截肢。截肢手术的平均终生费用现已超过70万美元。这项技术的实施改善了临床结果，在每个接受者的一生中可以节省数十万美元。这个小企业创新研究（SBIR）第一阶段项目展示了在治疗体积性肌肉损失的现有护理标准上的重大进步，目前还没有治疗方法。关节细胞和细胞外基质的损失造成了肌肉无法再生的环境，导致肌肉随着时间的推移而塌陷和萎缩。该项目有效地替代了因体积肌肉损失而丢失的细胞外基质，并创造了卫星细胞增殖和分化成新肌肉组织的环境。临床医生，特别是那些在军事医学的恶劣环境中工作的临床医生提出的一个技术问题是，在伤口床上植入异物会引起感染的风险。为了解决这个问题，技术目标1将侧重于加入抗菌剂，以优化支架促进肌肉再生的能力，同时还具有抗菌作用。将评估结构和机械性能，确保细胞活力，评估肌肉细胞质量，并测量抗菌性能。技术目标2旨在研究这些结果与试点猪模型的肌肉创伤。预计所提出的抗菌生物材料将既能对抗感染的风险，又能有效地再生创伤性肌肉损伤的功能肌肉。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.