Sernova Biotherapeutics announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to evaluate the Company's Cell Pouch auto-transplanted with thyroid cells in patients undergoing total thyroidectomy for nodular thyroid disease. Hypothyroidism, a condition characterized by insufficient production of thyroid hormones, affects millions of people worldwide, often requiring lifelong daily hormone replacement therapy. Sernova's Cell Pouch bio-hybrid organ, in combination with autologous thyroid cell therapy, aims to restore natural thyroid function by providing a long-term, stable, and physiological solution for patients suffering from post-operative hypothyroidism, without the need for immune suppression therapy.
Data from preclinical trials demonstrated that re-implantation of thyroid tissue into the pre-vascularized Cell Pouch, without immune suppression, resulted in the restoration of the two main thyroid hormones, thyroxine (T4) and triiodothyronine (T3), to pre-thyroidectomy levels, without any hormone supplementation. In addition, radio-isotope uptake imaging and histology assessments confirmed the presence of healthy and functional thyroid tissues within the Cell Pouch five months following re-implantation. Pending FDA clearance, Sernova will explore the initiation of a first-in-human clinical trial to evaluate the safety, tolerability, and efficacy of the Cell Pouch bio-hy hybrid organ with autologous thyroid cells in patients undergoing thyroidectomy for benign nodular disease.