Strategy to Isolate Regulatory T Cells Capable of Inducing Robust Immunoregulation

Utilizes Cell-Surface Markers to Isolate and Manipulate Treg Cells during Treatment and Prevention of Autoimmune and Inflammation-Mediated Diseases

This strategy enables the isolation of a potent population of regulatory T cells for autoimmune disease treatment by identifying specific surface markers characteristic of this cell population. The National Institutes of Health estimates that up to 23.5 million Americans have an autoimmune disease, with annual direct health care costs of approximately $100 billion in the United States alone. Available immunosuppressive drugs used to manage autoimmune diseases can be toxic and lead to cancer or opportunistic infection. T-cell therapy is an emerging area of autoimmune disease treatment that seeks to utilize regulatory T cells’ (Tregs) ability to modulate the immune system by controlling activity and growth of inflammation-mediating effector T cells. However, available biomarker strategies to identify and isolate Tregs are susceptible to contamination by other cell types which may result in outgrowth of contaminating T cells with effector T cell properties.

Researchers at the University of Florida have developed a method to consistently isolate stable thymic Tregs with robust immunosuppressive capacity, reducing the batch-to-batch variability that has impeded the broad usage of Treg therapy and instead offers potential targets for monoclonal antibody therapies. This may provide patients with autoimmune and inflammatory disease treatment options that will correct underlying disease processes without unwanted side-effects of systemic immunosuppression.

Application

Strategy to identify and isolate Tregs with robust immunosuppressive capacity to treat inflammation-mediated diseases

Advantages

• Utilizes previously uncharacterized biomarkers, allowing the identification of distinct subsets of Tregs
• Consistently isolates Tregs with robust immunoregulatory capacity and lineage stability, removing a key obstacle to T cell therapy for management of autoimmune diseases
• Provides additional targets for biologics R&D, supporting monoclonal antibody strategies to control inflammation-mediating T cell activity in autoimmune disease treatment

Technology

A sample of cells is taken from a patient and T cells are isolated via flow cytometry. Using the biomarkers identified in this technology, a population of regulatory T cells is isolated. This population is devoid of effector T cell contamination. The Tregs can then be grown and proliferated ex vivo for adoptive T cell therapy. The resulting population of Tregs is functionally pure and displays a high immunoregulatory capacity, which can be used to develop T cell therapeutics for control of overactive inflammation in autoimmune disease patients. Additionally, the biomarkers included in this technology may serve as targets for monoclonal antibody modulation of T cell activity, enabling development of a pharmaceutical alternative for medical management of inflammation-mediated diseases that avoids the dangerous side effects of current immunosuppressive drugs.