Development of the Biobreast

DESCRIPTION (provided by applicant): The most common malignancy in American women is breast cancer. Breast reconstruction for mastectomy currently involves two choices, implant or autologous tissue flap. Implant reconstruction is relatively simpler but istemporary, whereas flap reconstruction is permanent but much more complex. We propose here a novel method for breast reconstruction by implanting a novel three dimensional biodegradable scaffold. This scaffold is designed to accommodate the patient's ownomentum and fat tissues. Over time, the scaffold would be completely resorbed, leaving the patient's autologous tissue in the form of a new breast. This new method would offer a third choice for breast reconstruction that may potentially be superior to thecurrent options. The goals of this proposal are to perform necessary pre-clinical tests on the Biobreast scaffold device to enable a pre-IDE application to the FDA for approval of initiation of a future Phase 1 human clinical trial. Our specific aims areas follows: Aim #1: To carry out bench performance tests of the scaffold. Aim #2: To complete animal and toxicity studies of the scaffold. Aim #3: To submit a pre-IDE application to the FDA. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Breast reconstruction for mastectomy currently involves two choices, implant or autologous tissue flap. Implant/expander reconstruction is relatively simpler but is temporary, with operative time about 1-3 hours and 1-2 day hospital stays. Complications in implant breast reconstruction are 2-3 fold higher than in breast augmentation, and the typical implant only lasts a few years. Flap reconstruction is permanent but much more complex, requiring lengthy (6-12 hours), more costly operations, 4-6 day inpatient care, and 6-8 weeks of outpatient rehabilitation. The patient then has one or more permanent large scar(s) at the donor site(s). We propose here a novel method for breast reconstruction by implanting a novel three dimensional biodegradable scaffold. This Biobreast scaffold is designed to accommodate the patient's own omentum and fat tissues. Over time, the scaffold would be completely resorbed, leaving the patient's autologous tissue in the form of a new breast. Our proposal represents a novel solution by constructing a bioabsorbable scaffold to: 1) provide a breast shape to the omental tissue, and 2) to increase volume for reconstruction by providing a vascular supply to added autologous fat derived from liposuction. Our Biobreast scaffold offers potentiallymajor advantages to the current methods of breast reconstruction as follows: 1) Scaffold reconstruction is tissue-based without a permanent foreign body like an implant with its associated high complication and re-operation rate. 2) Operative time is several hours shorter than traditional flap reconstruction, and blood loss is significantly less, thus minimizing stress o the patient's body. 3) Postoperative monitor requirement is much less intensive than that for free flaps. 4) Hospital stay length is shorter, 1-2 days, and potentially not needed if the healthy patient goes home the same day. 5) Rehabilitation is anticipated to be many weeks less than traditional flap reconstruction. There is no permanent muscle loss, no large scars and potential defects atthe flap donor site(s).