I-Corps: A Tissue-engineered Nipple-Areolar Complex

Tulane University, New Orleans LA

Investigators

Abstract

Currently, there are more than 230,000 women diagnosed with breast cancer every year in the United States; and there are approximately 180,000 female mastectomies that occur each year due to cancer. These patients, mostly women, have several options in the way they could have their nipple-areolar complex (NAC) reconstructed. These options most commonly include the plastic and reconstructive surgeons, surgically creating a structure that looks like a nipple, out of skin from the chest area or from other part of the body, such as the thigh or under the arm; or a tattoo of a image of NAC can be done after the reconstructions phase of the breast; or a combination of tattoo or surgical methods. For these NAC reconstructions, the outcome is contingent on many factors: surgical skill, skin thickness, blood supply to the reconstructed nipple-like structure, tattooing skill, fading of tattoo, etc. As an alternative to these current standard methods to reconstruct the NAC this I-Corps team has have developed a graft that would regrow the patient's NACs. As an overall goal to this concept, an off-the-shelf ready NAC graft would be made available to the plastic and reconstructive surgeons. During the breast reconstruction phase, after a mastectomy, the surgeon would then engraft one of these NAC grafts in position onto the patient's reconstructed breast. The patient's body would then use this NAC graft as a building frame to regenerate their own NAC. Materials similar to these have been used in surgeries for more than 30 years; by reimaging these materials and their processing, it has allowed us to apply well-established processes and reconstruction methods to the regeneration of NACs for women who have undergone mastectomies. There exists a need for a reproducible off-the-shelf ready graft for Nipple-Areolar Complex (NAC) reconstruction, for the approximately 180,000 mastectomies that. There are more than 2.8 million breast cancer survivors in the United States, many of who have undergone reconstructive surgery. Approximately 36% of patients with early stage diagnoses and 60% of patients with late stage diagnoses undergo mastectomies. Moreover, immediate breast reconstruction following mastectomies has become more common, significantly increasing at from 20.8% in 1998 to 37.8% in 2008. This increasing trend is not surprising as there is evidence to suggest that NAC reconstruction affects psychological wellbeing of female patients who have undergone mastectomies. Evidence also suggests that woman are more comfortable with getting a mastectomy if the nipple can be spared during the mastectomy procedure, or if nipple reconstruction is possible if a nipple-sparing mastectomy is not an option. Current strategies for NAC reconstruction are limited to surgical techniques that create a NAC-like structure from existing local tissue, secondary site grafting, or 3D tattooing, or a combination of surgical reconstruction with tattooing. Generating a tissue engineered, biocompatible NAC graft for use in place of surgically created NAC structures is a promising approach to NAC reconstruction following mastectomies. To date, no tissue engineering strategies have been targeted towards the regeneration of the NAC structure. By isolating a biological-derived collagen-rich acellular NAC scaffold, the NAC native micro and macro structural components are maintained. The goal of this overall project is to provide the plastic and reconstructive surgeons an off-the-shelf ready NAC graft, that could be onlay grafted onto the patient during breast reconstruction, allowing for patient resident skin-cells to repopulate the scaffold, thereby regenerating the patients' NAC.