SBIR Phase II: An Injectable Protein Matrix to Enhance the Stability of Autologous Fat Grafts

SBIR II 期：可注射蛋白质基质，增强自体脂肪移植物的稳定性

• 批准号: 2304430
• 负责人: Stefan Roberts
• 金额: $ 97.92万
• 依托单位: INSOMA BIO INC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2304430&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Injectable; Protein

The broader impact of this Small Business Innovation and Research (SBIR) Phase II Project will improve clinical outcomes for the thousands of patients globally who undergo craniofacial repair surgery each year. Facial disfigurement, whether congenital or acquired, can have profound physical and psychosocial implications including altered body image, reduced quality of life, and poor societal integration. Fat grafting is one of the most rapidly growing procedures in facial reconstructive surgery due to its lack of reliance on foreign or synthetic materials, safe harvest, and minimal surgical risk. While fat grafting has potential to make groundbreaking strides in facial reconstruction, the technique is held back by unreliable volume and shape loss. Craniofacial repairs are particularly challenging for surgeons given the requirement for exquisite control of graft shape and volume. The product supported by this proposal has the capacity to dramatically improve the shape, volume, and survivability of grafted fat. This technology has the potential to not only provide a novel and innovative option for clinicians facing challenging craniofacial cases, but success in this beachhead market will also support the rapidly growing utility of fat grafting in other procedures such as breast reconstruction, amputation site bulking, and hand/foot pad repair. The proposed project is focused on the development and commercialization of a recombinant, protein-based biopolymer engineered from human elastin to enhance the use of fat grafting in craniofacial reconstruction. This product is one of the first materials to make use of a new paradigm in understanding protein engineering: that highly disordered proteins with defined 3D structure play key roles in the mechanical and biological activity of the body. Using iterative design and molecular engineering of specific protein ordered and disordered domains, the team has generated a new class of biomaterials that are uniquely suited to meet the key criteria for a fat grafting support matrix including: (1) a temperature-dependent phase transition from a liquid to a moldable solid at body temperature, (2) a porous matrix that allows cellular infiltration and supports long-term viability of the tissue in vivo as well as the vascularization required for tissue viability, and (3) enhanced protein stability that allows simple use at the point-of-care with minimal modification to current clinical practice. This Phase II project will focus on core needs for scale-up, toxicity studies, biocompatibility, and large animal efficacy evaluations in preparation for regulatory submission, clinical evaluation, and commercial approval.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.

这项小型企业创新与研究（SBIR）二期项目的广泛影响将改善全球每年接受颅面修复手术的数千名患者的临床结果。面部毁容，无论是先天的还是后天的，都可能产生深刻的生理和心理影响，包括身体形象的改变，生活质量的降低和社会融合的不良。 脂肪移植是面部重建手术中发展最快的手术之一，因为它不依赖于外来或合成材料，安全的收获和最小的手术风险。虽然脂肪移植有可能在面部重建方面取得突破性的进展，但该技术受到不可靠的体积和形状损失的阻碍。颅面修复对于外科医生来说特别具有挑战性，因为需要精确控制移植物的形状和体积。该提案所支持的产品具有显著改善移植脂肪的形状、体积和存活性的能力。这项技术不仅有可能为面临挑战性颅面病例的临床医生提供一种新颖和创新的选择，而且在这个滩头市场的成功也将支持脂肪移植在其他手术中快速增长的实用性，如乳房重建，截肢部位膨胀和手/脚垫修复。拟议项目的重点是开发和商业化的重组，蛋白质为基础的生物聚合物工程从人类弹性蛋白，以提高使用脂肪移植在颅面重建。该产品是首批利用新范式理解蛋白质工程的材料之一：具有明确3D结构的高度无序蛋白质在身体的机械和生物活性中发挥关键作用。使用特定蛋白质有序和无序结构域的迭代设计和分子工程，该团队已经生成了一类新的生物材料，这些材料非常适合满足脂肪移植支持基质的关键标准，包括：（1）在体温下从液体到可模塑固体的温度依赖性相变，（2）多孔基质，其允许细胞浸润并支持组织在体内的长期生存力以及组织生存力所需的血管形成，和（3）增强的蛋白质稳定性，其允许在护理点（point-of-care）简单使用，对当前临床实践的修改最小。该项目的第二阶段将集中在扩大规模的核心需求，毒性研究，生物相容性和大型动物的有效性评估，为监管提交，临床评估和商业批准做准备。该奖项反映了NSF的法定使命，并被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。