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Sernova Advances Cell Pouch Therapy For Hypothyroidism With FDA IND Submission

Sernova seeks FDA approval to trial its Cell Pouch for restoring thyroid function in post-thyroidectomy patients.

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  • Feb 04, 2025

  • Simantini Singh Deo

Sernova Advances Cell Pouch Therapy For Hypothyroidism With FDA IND Submission

The U.S. Food and Drug Administration received an Investigational New Drug application from Sernova Biotherapeutics. The application seeks to study the Company’s Cell Pouch containing auto-transplanted thyroid cells for patients who undergo total thyroidectomy because of nodular thyroid disease. Hypothyroidism impacts numerous people globally as a thyroid hormone production deficiency that needs daily hormone treatment. The Sernova Cell Pouch bio-hybrid organ used alongside autologous thyroid cell therapy works to restore natural thyroid function through long-term physiological treatment of hypothyroidism patients without requiring patients to use immune suppressors. 

Jonathan Rigby, CEO of Sernova, commented, “This IND submission represents a step forward in our commitment to transforming endocrine disorder treatment. Our Cell Pouch has shown the ability to establish a vascularized, organ-like environment for transplanted cells, and we believe this innovative approach could restore thyroid function and enhance the quality of life for patients facing lifelong hypothyroidism.”

The preclinical trials showed that thyroid tissue re-implanted into the pre-vascularized Cell Pouch maintained pre-thyroidectomy thyroid hormone levels of thyroxine (T4) and triiodothyronine (T3) without requiring hormone supplements during immune suppression-free treatment. Chromic and histological evaluations five months post-implantation proved that re-implanted thyroid tissues matured into viable and functioning tissues within the Cell Pouch. Sernova will begin procedures to obtain FDA approval before starting a first-in-human trial to measure both the safety, tolerability, and effectiveness of the combined Cell Pouch bio-hybrid device and autologous thyroid cells in patients who have benign nodular disease requiring thyroidectomy.


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