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

这个小企业创新研究一期项目提出了一种用于重建手术的新的组织工程血管化脂肪移植产品。在全球大约100万例新发乳腺癌病例中，许多患者由于缺乏可行的重建选择而选择乳房切除术。这项研究的长期目标是建立一种比传统产品更能与患者自然结合的自体组织结构。这项拟议中的研究将使用一种新的生物打印技术来制造毛细血管通道，假设这种毛细血管通道可以与宿主组织快速吻合，从而使实验室培养的组织在移植到患者体内后存活下来。研究小组将构建结构，确定打印组织的最佳参数，并测量与小鼠模型吻合的可行性。研究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。在此基础上，可以决定在更大的动物身上进行血管化前移植试验。这项研究的结果预计将影响目前的几种治疗方案，如乳房肿瘤切除术后自体脂肪移植乳房重建，每年在美国约有11万人受到影响。该项目的广泛影响/商业潜力将改善因癌症肿瘤切除、先天性缺陷和创伤性损伤而患有畸形的人的生活质量。乳房肿瘤切除术后不对称的乳腺癌患者更容易相信癌症会复发，更容易抑郁；据估计，25-30%的乳腺癌患者对乳房肿瘤切除术的结果不满意，而乳房肿瘤切除术的重建选择很少。本文提出的方法，如果成功，应该解决这个问题，允许一个更自然的解决方案，利用病人自己的细胞，理论上良好的预后。组织工程领域目前仅限于小而薄的结构，由于营养丰富不足（即脉管系统）。生物打印技术的进一步发展和体外细胞重组构建血管化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成果。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整个器官发展。这项研究的商业影响将是在利润丰厚的100亿美元隆胸市场上为女性提供一种自体选择。

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.