SBIR Phase I: Bioprinted Prevascularized Adipose Graft for Soft Tissue Voids

这个小企业创新研究第一阶段项目提出了一种新的组织工程化血管脂肪移植产品，用于重建手术。在全世界约100万新的乳腺癌病例中，由于缺乏可行的重建选择，许多患者选择了乳房切除术。这项研究的长期目标是建立一种自体组织结构，比传统产品更能与患者自然结合。这项拟议的研究将使用一种新的生物打印技术来创建毛细血管通道，假设这些通道可以快速与宿主组织接合，从而允许实验室培养的组织在移植到患者身上后存活下来。研究小组将构建结构，确定打印组织的最佳参数，并用小鼠模型测量吻合的可行性。这一结果将有助于制定生物打印毛细血管与宿主快速吻合的设计规则。从这一点开始，我们就可以决定在更大的动物身上测试血管前移植物。这项研究的结果预计将影响目前的几种治疗方案，例如肿块切除后用于乳房重建的自体脂肪移植，每年在美国约有11万人受到影响。该项目的更广泛影响/商业潜力将改善因癌症肿瘤切除、先天性缺陷和创伤而导致的畸形患者的生活质量。乳腺癌肿块切除术后不对称的患者更有可能相信癌症会复发并抑郁；据估计，25%-30%的乳腺癌患者对肿块切除术的结果不满意，肿块切除术的重建选择很少。这里提出的方法，如果成功，应该可以解决这个问题，允许更自然的解决方案，利用患者自己的细胞，理论上具有良好的预后。由于营养丰富不足(即血管系统)，组织工程领域目前仅限于小而薄的结构。进一步发展生物打印过程和细胞体外重组以构建血管组织类似物将在组织工程和再生医学领域产生新的方法和结果。这项研究的结果将有助于该领域向更大的、临床相关的组织和潜在的完整器官发展。这项研究的商业影响将是在利润丰厚的100亿美元(美国)隆胸市场上为女性提供自体选择。

This Small Business Innovation Research Phase I project proposes a new tissue engineered vascularized adipose graft product for reconstructive surgery. Of the approximately one million new breast cancer cases worldwide, many patients choose mastectomy due to a lack of viable reconstructive options. The long-term objective of this research is to build an autologous tissue structure that can integrate more naturally with the patient than conventional products. The proposed research will use a new bioprinting technology to create capillary channels that are hypothesized to anastomose with host tissue quickly, thereby allowing lab-grown tissues to survive once transplanted to the patient. The research team will build constructs, determine optimal parameters for printing tissue, and measure feasibility of anastomosis with mouse models. The results will help the development of design rules for bioprinted capillaries with respect to rapid anastomoses to the host. From here a decision can be made to move forward with testing pre-vascularized grafts in larger animals. The results of this study are expected to impact several current treatment regimes, such as autologous fat grafting for breast reconstruction following lumpectomy, affecting approximately 110,000 people in the US annually.The broader impact/commercial potential of this project will improve the quality of life for people suffering from deformity due to cancer tumor removal, congenital defects and traumatic injuries. Patients with asymmetry following lumpectomy treatment for breast cancer are more likely to believe the cancer will reoccur and to be depressed; it is estimated that 25-30% of breast cancer patients are dissatisfied with the outcome of a lumpectomy and few reconstructive options exist for lumpectomies. The methods presented herein, if successful, should solve this problem, allowing a more natural solution utilizing the patient's own cells with a theoretically excellent prognosis. The field of Tissue Engineering is currently limited to small, thin constructs due to inadequate nutrient profusion (i. e., Vasculature). Further development of the bioprinting process and the reassembling of cells in vitro to construct vascularized tissue analogs will generate new methods and results in the fields of Tissue Engineering and Regenerative Medicine. The results of this research will help the field move towards larger, clinically relevant tissues and potentially whole organs. The commercial impacts of this research will be the availability of an autologous option for women in the lucrative $10B (US) market for breast augmentation.