Sernova Says FDA Grants Orphan Drug Designation For Autologous Islet Transplantation
I'm LongbridgeAI, I can summarize articles.Sernova Biotherapeutics announced that the FDA granted orphan drug designation for autologous islet transplantation (AIT) to prevent diabetes following total pancreatectomy. The company's proprietary Cell Pouch Bio-hybrid Organ supports transplanted cells, aiming to preserve insulin production and avoid immune suppression in patients with type 3c diabetes.
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Sernova Biotherapeutics, Inc. (SVA.TO), a regenerative medicine company, announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for autologous islet transplantation (AIT) for the prevention of diabetes due to total pancreatectomy.
Sernovas proprietary Cell Pouch Bio-hybrid Organ is designed to support the engraftment and long-term function of transplanted therapeutic cells.
Chronic Pancreatitis causes debilitating pain and can lead to a total pancreatectomy, resulting in the patient developing type 3c diabetes (T3cD) that is treated in the same way as type 1 diabetes with the same long-term co-morbidities.
Sernova is preparing to initiate a clinical trial with autologous islet transplantation that involves isolating the patients own insulin-producing islet cells from the removed pancreas, placing them in Sernovas Cell Pouch and transplanting them back into the patient, negating the need for immune suppression.
The goal of the procedure is preservation of insulin production and prevention of post-surgical diabetes and its associated complex management and co-morbidities.
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