I-Corps: Personalized Tissue Engineering

I-Corps项目更广泛的影响/商业潜力是组织工程和再生医学平台技术的潜在商业化。复杂的组织损伤和不愈合的伤口代表了一个全球性的治疗挑战，使组织工程和再生医学具有数十亿美元的商业机会，但仍有许多未满足的临床需求。今天，大多数伤口护理产品依赖于“降解和替换”机制，由炎症介导，导致瘢痕组织紊乱。该项目所基于的创新技术通过“持续和再生”的机制来恢复组织结构和功能。此外，这些材料具有独特的定制能力，将其定位为未来的应用领域，包括软组织重建，如肿瘤切除后；肌腱、韧带和骨的修复；组织膨胀剂治疗尿失禁或喉部麻痹；细胞疗法，如胰岛移植治疗糖尿病。综上所述，这些特性将有可能为个性化组织工程提供创新、低成本的产品，从而有可能降低医疗成本并改善患者的治疗效果。I-Corps项目是基于一种先进的组织衍生产品，即聚合物自组装基质，它代表了第一个可注射的胶原蛋白，它具有自组装的能力，即在注射时从液体转变为稳定的纤维支架。这项技术的灵感来自于新的机制见解：1)胶原蛋白的合成和组装发生在体内；2)依赖于细胞-胶原蛋白生物物理相互作用的机械生物学信号。因为聚合体通过形成胶原原纤维立即恢复自然组织结构，就像在体内发现的那样，这种天然生物材料是非炎症的，并表现出优越的组织再生能力。通过结合细胞和定制支架结构（密度、形状和结构），Collymers具有独特的患者定制能力，使其成为第一个个性化的组织再生/工程技术。I-Corps项目的具体目标是探索和优先考虑这项技术最有前途的应用，以及考虑诸如报销、监管路径和客户细分等因素的最佳商业化路径。

The broader impact/commercial potential of this I-Corps project is the potential commercialization of a platform technology for tissue engineering and regenerative medicine. Complex tissue injuries and non-healing wounds represent a global therapeutic challenge, making tissue engineering and regenerative medicine a multi-billion commercial opportunity with many unmet clinical needs. Today most wound care products rely on a "degrade and replace" mechanism, mediated by inflammation and resulting in disorganized scar tissue. The innovative technology, on which this project is based, works by a mechanism of "persist and regenerate" to restore tissue architecture and function. Additionally, these materials have unique capacity for customization, positioning it for future applications in areas including soft tissue reconstruction such as after tumor removal; repair of tendons, ligaments, and bone; tissue bulking agents for treating urinary incontinence or laryngeal paralysis; and for cellular therapies such as islet transplantation for diabetes. Taken together, these attributes will potentially enable innovative, low-cost products for personalized tissue engineering that have potential to reduce health care costs and improve patient outcomes.This I-Corps project is based on an advanced tissue-derived product, namely Collymer Self-Assembly Matrix, which represents the first injectable collagen which exhibits self-assembly-the ability to transition from a fluid to a stable fibrillar scaffold upon injection. This technology was inspired by new mechanistic insights into i) collagen synthesis and assembly as occurs within the body and ii) mechanobiology signaling which relies on cell-collagen biophysical interactions. Because Collymers immediately restore the natural tissue architecture by forming collagen fibrils just like those found in the body, this natural biomaterial is non-inflammatory and exhibits superior tissue regeneration. Collymers' unique capacity for patient-specific customization by incorporating cells and customizing the architecture of the scaffold (density, shape, and architecture) makes it the first personalized tissue regeneration/engineering technology. The specific aims of the I-Corps project is to explore and prioritize most promising applications for this technology as well as the best path to commercialization considering factors such as reimbursement, regulatory path and customer segment.