An innovative approach to cell replacement
The Seraxis technologies provide a cure for insulin-dependent diabetes by replacing the lost insulin producing pancreatic cells with lab-grown cells, packaged within a device to protect the cells from immune rejection. This regenerative medicine strategy causes sustained reversal of diabetes in animal models.
Cells
Seraxis scientific and medical experts have developed a stem cell line, SR1423 and differentiation protocol that reproducibly matures SR1423 cells to islets. These islets are organized like native islets containing cells secreting insulin and the other pancreatic hormones. The proprietary, clinically compliant (cGMP) stem cell line was generated from human pancreas.
The advantages of these cells over others cell lines, such as embryonic stem cells or iPS cells, are that they are capable of generating highly pure populations of therapeutic cells and have a better safety profile.
Lab-grown islets for transplant
Islets are clusters of hormone-secreting cells distributed through the pancreas. These hormones, insulin, glucagon and others, maintain a healthy level of glucose in the blood. The islets of type 1 diabetics are damaged. Seraxis islets mimic native islets from a human pancreas.
Functioning islets secrete more insulin when the level of glucose in the blood elevates, and less insulin when glucose level drops. A complex pattern of insulin secretion occurs in concert with other pancreatic and digestive hormones to keep blood glucose within a narrow range in healthy people. The graph below shows that Seraxis islets, SR1423 secrete insulin in response to glucose in the same manner and quantity as a native pancreatic islet.
After implant to animal models, Seraxis islets functionally replace native islets. This image shows an endocrine pancreas in an animal model created from Seraxis islets.
The Seraxis cell therapy reverses diabetes in immune-competent rats and mice.
The mice represented in the graph below maintained normal blood glucose for the length of the study, more than 9 months. The implant is safe and well-tolerated. No adverse effects were observed in these animals.
Device
Our scientific and medical experts have developed an implantable biocompatible device, SeraGraft © that protects the therapeutic cells from immune recognition.
A unique feature of the Seraxis device is that it encourages close association with the patients’ vasculature so that blood glucose can be precisely regulated, similar to the native pancreas.
SeraGraft © containing a therapeutic dose of Seraxis islets associates with the host vasculature after implant. This enables the replacement islets to survive and function without being recognized by the host immune system.
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