Implant of a reabsorbable scaffold in non-malignant breast lesions treated by excision or lumpectomy: A First In Human pilot study

My PhD study is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with non-malignant breast lesions up to 200 cc in volume, eligible for lumpectomy. The aim is to determine safety and feasibility of an innovative breast reconstructive approach after conservative surgery. This consists of an in vivo tissue engineering approach based on the combination of conservative surgery and a biodegradable polyurethane cell-free scaffold intended for regenerating soft tissue resembling fat. The purpose is to acquire preliminary information on this biomimetic device to design an adequate development plan. Albeit on a very limited number of patients treated, the data collected showed a positive outcome both in terms of safety and performance. This is significant because based on the quantity of breast tissue that must be removed, conservative surgery may not always be able to obtain satisfactory cosmetic results unless resorting to more complex oncoplastic techniques. Therefore, having an alternative technique that optimizes the aesthetic outcomes while minimizing surgical invasiveness, duration, and complexity, is highly desirable. This innovative breast reconstructive approach represents an alternative to current surgical options, being able to restore a natural breast in a single step, safe, easy-to-adopt, and potentially cost-saving procedure. Furthermore, it can have remarkable impact on research and clinical application of tissue engineering to bulky, highly vascularized tissues. Further analysis on a larger sample and with a longer follow-up is necessary to confirm these results.