Pectus Excavatum Camouflage (IT)

The clinical study evaluates the use of a custom-made medical-grade polycaprolactone-PCL Pectus scaffold implantation with Autologous Fat Grafting for pectus excavatum camouflage (IT). The study aims to demonstrate the safety and clinical performance of the insertion of an absorbable "medical-grade polycaprolactone-PCL Pectus Scaffold" in the thorax region with Autologous Fat Grafting in the correction of congenital Pectus Excavatum unsuitable for conventional treatment with stable cardio-respiratory function.The PCL Pectus Scaffold-based design has the potential to induce sustained regeneration to fill large volume pectus excavatum defects, with the added benefit of being light weight and resorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.

Inclusion Criteria:Genetic female patients of age 14 years and up OR Genetic male patients of age 16 years and up without cardiopulmonary compromise seeking correction or improvement of pectus excavatum-associated with anterior chest wall deformity and/or congenital defect.Patient willing and able to comply with the study requirements (e.g., all scheduled appointments).Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, no history of severe claustrophobia).Patient and his/her parents/legal guardian (in case of minor patients) capable of providing valid written informed consent.Have sufficient body fat for homologous transplantation.The patient/Guardian has "realistic" expectations of surgical results as determined by the PI.Exclusion Criteria:Genetic females less than 14 years of age at the time of surgery.Genetic males less than 16 years of age at the time of surgery.Active infection anywhere in the body.Patient chest wall tissue is clinically incompatible for the procedure as determined by PI.Compromised vascularity in the pectoralis muscle and subcutaneous tissue.Patient and is/her parents/legal guardian (in case of minor patients) unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy, or other cause for secondary/primary immunodeficiency.Known severe concurrent or inter-current illness including cardiovascular, respiratory, or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Co-ordinating Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results.Patient with unstable cardiac or respiratory function due to pectus excavatum or those still requiring functional repair.Body mass Index (BMI below 20 and above 30 (patients with a BMI above 30 may still be eligible pending assessment by investigating team and documentation of rationale).Female patients who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the pectus excavatum camouflage surgery.Female patients of childbearing potential without an appropriate contraceptive method.Patient ineligible to undergo MRI.Patient life expectancy < 36 months.Patient unable or unwilling to comply with the treatment protocol.