All about Islet Cell

RGB-5088 is a novel treatment for Type 1 Diabetes currently under investigation.

This innovative therapy focuses on islet cell transplantation and is presently in a phase I clinical trial aimed at assessing its safety and effectiveness.

The RGB-5088 islet cell injection utilizes small molecule induction technology. This process reprograms somatic cells into pluripotent stem cells, which are then developed into islet cells to replace the malfunctioning islet cells in the patient's body, thus achieving long-term stable control of blood glucose levels. The islet cells produced through RGB-5088 consist of three types of endocrine cells that play a role in blood sugar regulation: α cells that produce glucagon, β cells that generate insulin, and δ cells that release somatostatin. These cells not only resemble adult islet cells structurally but also exhibit high glucose sensitivity functionally, allowing them to adjust insulin secretion in response to fluctuations in blood sugar levels.

Since July 2023, the study has successfully enrolled its first patient with Type 1 Diabetes, who has a history of 11 years.

The clinical study presented the findings of this patient one year later as an initial analysis of a first-in-human Phase I clinical trial (ChiCTR2300072200). This trial assessed the viability of autologous transplantation of chemically induced pluripotent stem cell-derived islets (CiPSC islets) beneath the anterior sheath of the rectus abdominis muscle for the treatment of Type 1 Diabetes. The results of the clinical study indicated that the patient started to consistently eliminate insulin dependence 75 days post-transplantation. The patient's blood sugar target time range improved from 43.18% at baseline to 96.21% by the fourth month following transplantation, while glycated hemoglobin (a marker of long-term systemic blood sugar levels at non-diabetic levels) showed a decrease. Since that time, the patient's blood sugar management has remained stable, with a blood sugar target time range exceeding 98% and glycated hemoglobin around 5%. One year later, the clinical data fulfilled all study endpoints without any transplant-related complications. The positive outcomes for the patient imply that additional clinical studies are warranted to assess the application of CiPSC-islet transplantation in Type 1 Diabetes.

This efficacy has remained stable for over a year. These results demonstrate the significant effectiveness and favorable safety profile of RGB-5088 islet cell injection in treating diabetes, generating considerable optimism for its future clinical applications.

The findings of this research were published in the prestigious journal Cell on September 25, 2024. https://www.sciencedirect.com/science/article/abs/pii/S0092867424010225.