Project description
Innovative treatment to reduce causes of type 1 diabetes
Diagnosed early in life, type 1 diabetes is an incurable, autoimmune disease. It accounts for 10 % of the almost 400 million global cases. Its causes are not fully known and prevention strategies have not yet been successful. The EU-funded TREG project is working to change this. It is developing a somatic cell therapy with T-regulatory cells obtained from the patient’s blood. The treatment’s innovativeness lies in the reduction of the disease’s causes, not only the clinical symptoms. Embarking on phase III of clinical development will also involve assessment of the safety and efficacy of the therapy in a broader paediatric population.
Objective
The main challenge of the project is to prepare and start Phase III of clinical development of TREG – a ground breaking Type 1 Diabetes (T1D) somatic cell therapy with T-regulatory cells obtained from the patient’s blood. T1D preventions strategies has not yet been successful. TREG project aims to change it and become first efficient prevention T1D therapy. The uniqueness and innovativeness of the treatment lies in the reduction of the disease causes, and not only its clinical symptoms which improves the quality of life and clinical parameters of patients.
The TREG therapy, patented technology, is a response to the largest, according to World Health Organization, global health emergencies of the 21st century – diabetes. In 2014 422 million people in the world had diabetes compared to 108 million in 1980. It means the global prevalence (age-standardized) of diabetes has nearly doubled since 1980 rising from 4.7% to 8.5% in the adult population and will be still growing. According to IDF Diabetes Atlas 2017 it is estimated that among them 7% to 12% have type 1 diabetes. While DM2 is more common, it is potentially preventable. The causes and risk factors for T1D remain unknown and prevention strategies has not yet been successful.
Majority of the efforts in the area of T1D treatment are put on the production of insulin preparations or development of medical devices connected with insulin admission and glucose control. Progress in this area has significant influence on the quality of patient’s life, but in fact they don’t remove the causes of the illness.
As a result of the proposed project, PolTREG will start the next stage of clinical trials (Phase III) on the safety and efficacy of the therapy in a broader pediatric population. If successful, the project will accelerate availability of a breakthrough therapy to the T1D patients and put PolTREG on a path of business development by a full-scale commercialization of the innovation.
Fields of science
Programme(s)
Funding Scheme
SME-2 - SME instrument phase 2Coordinator
80-298 GDANSK
Poland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.