SBIR-STTR Award

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

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the delivery of a custom-made nipple made from a patient's own cells for women who have had a mastectomy due to breast cancer. In the US about 300,000 women are diagnosed with breast cancer annually and nearly 40% will undergo mastectomies, full removal of the breast. A third of them will opt for breast reconstruction, most of whom will desire a nipple. Patients with loss of the nipple areola complex (NAC) from cancer treatments continue to experience psychological distress long after breast mound reconstruction has taken place, yet currently available options for nipple reconstruction are vulnerable to an unpredictable degree of loss of nipple projection, symmetry, color and possible need for reoperation. The technology can be evolved to treat other unmet needs in reconstruction and the cosmetic surgery field. The technology in this project can contribute to the scientific knowledge fundamental to 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 the creation of whole organs.This project will investigate, develop tools and techniques, and select best formulation for the ultimate delivery of a graft that has been tissue engineered to address the lack of reconstructive solutions for women that have undergone mastectomies and desire nipple reconstruction. The research aims of the Phase II project will demonstrate further viability of the scientific concepts proposed, such as impact of vascularization on volume retention, and develop tools/techniques for engineering shaped adipose tissue constructs (relevant to nipple projection). The project will test and select best formulation for adipose constructs as measured by in vivo volume retention, host reaction and vascular infusion. The research proposes to further optimize size and projection parameters and develop methods to assess and characterize incoming materials to reproducibly fabricate constructs with the correct size and desired volume retention.