Diabetes Research Institute Announces Breakthrough Transplantation Approach for the Treatment of Type 1 Diabetes at ADA 2024
Article Summary
- Dr. Giacomo Lanzoni and the Diabetes Research Institute announced a new approach to Type 1 diabetes treatment based on pancreatic islet cell replacement from unrelated donors.
- The approach alleviates the need for lifelong immunosuppression for patients.
- Researchers found the combination of iTOL-100 microgel and IsletRx stem cell-derived islets restored normoglycemia in a model of diabetes.
The Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine unveiled an innovative approach at the American Diabetes Association’s (ADA) 84th Scientific Sessions that highlights the potential of human, stem cell-derived islets combined with an immunomodulatory microgel to reverse Type 1 diabetes (T1D).
This technology was developed to enable pancreatic islet cell replacement in the allogeneic setting (from a donor to an unrelated recipient) without the need for chronic, systemic immunosuppression.
The collaborative effort was spearheaded by Giacomo Lanzoni, Ph.D., a Miller School research assistant professor in biochemistry and molecular biology, with teams from iTolerance, Inc., and Kadimastem, Ltd. The research demonstrates that the combination of iTOL-100 engineered microgel developed by iTolerance, Inc., and IsletRx stem cell-derived islets developed by Kadimastem, Ltd., can effectively restore normoglycemia in a model of diabetes.
“Our observations highlight the transformative potential of combining stem cell-derived islets with an immunomodulatory microgel,” Dr. Lanzoni said. “This approach could enable transplantation across the allogeneic barrier, offering a scalable and sustainable solution for T1D, and could enhance the safety and long-term efficacy of islet cell transplantation.”
“The Fast Track Center for Testing at the DRI Cell Transplant Center continues to serve as a key shared resource to validate emerging technologies towards a cure for diabetes,” said Camillo Ricordi, M.D., director of the Cell Transplant Center and director emeritus at the Diabetes Research Institute as well as chief in the Division of Cellular Transplantation at the Miller School. “We hope to continue to be of assistance towards the identification of reliable and potentially unlimited stem cell-derived islet sources for transplantation, which may one day be able to replace the limited availability of pancreas-derived islets from multiorgan donors, when lifelong recipient immunosuppression will no longer be required.”
The study’s key findings indicate that this combination therapy reverses diabetes and preserves the functional integrity of the transplanted stem cell-derived islets.
Key highlights:
• iTOL-100, an immunomodulatory microgel designed to eliminate the need for chronic systemic immunosuppression and shown to induce local immune acceptance of transplanted islets, was found to be compatible with stem cell-derived islets.
• IsletRx, a preparation of human, stem cell-derived islets, is a scalable and virtually unlimited source of insulin-producing cells and could address the critical shortage of donor islets for transplantation.
• The transplantation procedure is performed in a retrievable site, ensuring the possibility of graft retrieval through a minimally invasive surgery, if needed.
• The study reports reversal of disease in a chemically induced model of diabetes, with comparable efficacy of IsletRx in the presence or absence of iTOL-100, indicating a lack of toxicity from the microgel.
“iTolerance is pleased to co-sponsor the project at the Diabetes Research Institute toward a functional cure of T1D through the combination of human stem cell-derived insulin producing islet cells together with our iTOL-100 proprietary immunomodulator,” said Anthony Japour, M.D., CEO of iTolerance, Inc. “Removing the need for life-long toxic immunosuppressive agents in islet transplantation is a common goal among those working toward a cure for T1D through transplantation without immunosuppression.”
“Our collaboration with iTolerance opens an innovative and world-first avenue for transplanting pancreatic islet cells into people with diabetes without the need for full suppression of the immune system, which is required today in organ transplants,” said Michel Revel, M.D., Ph.D., chief scientist at Kadimastem, Ltd. “Our company produces high-quality pancreatic islet cells. The joint data collected by us proves the possibility of combining our cells with the material that locally prevents the rejection of the implant developed by our project partner iTolerance. Having successfully completed an Interact meeting with the FDA, the two companies are moving together to the pre-IND submission stage.”
IsletRx is comprised of clinical-grade clusters of human pancreatic islet like cells (ILCs) with the ability to secrete insulin. IsletRx cells can detect the sugar levels in the body and produce the required amounts of insulin and glucagon. The company’s technology can select and enrich only the highest functioning and purest islet cells from the population of pluripotent stem cells, which enables the maximum therapeutic effect.
The project was supported in part by iTolerance, Inc., Kadimastem, Ltd., grants funded by the Breakthrough T1D Foundation (formerly known as JDRF) and the Israel-U.S. Binational Industrial Research (BIRD) Foundation.
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Tags: Camillo Ricordi, diabetes, Diabetes Research Institute, DRI, giacomo lanzoni, islet cell transplantation, pancreas