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Type 1 diabetes (T1D) is an autoimmune condition where the body's immune system attacks and destroys the insulin-producing beta cells in the islets of the pancreas, requiring type 1 diabetics to inject insulin daily to replace what's not being produced. T1D is commonly diagnosed during childhood or early adolescence and requires constant monitoring to reduce the risk of episodes of low blood sugar (hypoglycemia) and long-term complications.
Developing a 'functional cure' for T1D has been at the forefront of medical research, especially as science and technology have advanced. Many of these functional cures have involved the transplantation of pancreatic cells to replace the damaged and dead ones. In a similar vein, Canada-based regenerative medicine therapeutics company Sernova Corp has reported very promising results from early clinical trials using its novel Cell Pouch System technology in type 1 diabetics.
"This first-in-world data is potentially game-changing for Sernova and, more specifically, provides tangible hope for T1D patients that we are a significant step further in our mission of providing a functional cure for this terrible disease; as a type 1 diabetic myself, I could not be more determined to drive our program forward and ultimately onto the market," said Jonathan Rigby, president and CEO of Sernova.
Sernova's Cell Pouch System is a small, implantable medical device that's inserted under the skin against the abdominal muscle and contains stem-cell-derived 'therapeutic cells' – in the case of type 1 diabetics, cells that produce insulin. Because the device is porous, after implantation blood vessels infiltrate it and form a biocompatible tissue environment that ensures the long-term survival and function of the cells it houses.
About six weeks after implantation of the Cell Pouch, which allows time for patients to be stabilized on immune-suppressing therapy, islet cells are transplanted into the vascularized tissue chambers formed by the pouch. (Immunosuppressants reduce the risk that the patients' bodies will reject the transplanted cells.) Patients can receive 'top-up' islet transplants if they are still dependent on insulin six months after the last transplant. Those trial participants who retained their implants were followed up for at least three years.