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iTOL-102 is an investigational allogeneic stem cell-derived pancreatic islet therapy being developed as a potential cure for Type 1 Diabetes. The therapy combines Kadimastem’s IsletRx technology—clusters of insulin-secreting, human stem cell-derived pancreatic islets—with iTolerance’s proprietary immunomodulatory microgel platform, iTOL-100. This combination aims to enable transplantation of insulin-producing cells without the need for life-long systemic immunosuppression by inducing localized immune tolerance at the transplant site. The mechanism involves replacing lost or dysfunctional pancreatic beta cells and using a synthetic Strepavidin-FasL fusion protein (FasL) in a biotin-PEG microgel to prevent immune rejection by binding Fas receptors on activated T-cells and promoting apoptosis, while expanding regulatory T-cells to create long-term local immune privilege. Preclinical studies have demonstrated functional insulin release and disease reversal in animal models, with ongoing development supported by collaborations between iTolerance and Kadimastem[1][2][3][4][5][6][7].
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