Objective The applicant aims at delivering economically sustainable and innovative cell therapy dedicated to the treatment of DM1 with the use of TREGs vaccine. The TREG therapy, covers almost all aspects listed in the call, i.e. cell identification, sorting, culture, multiplication (all 4 steps covered in patent), banking, transport, delivery (running clinical trial) and strict quality control. The project’s objective is to increase the commercial success of the therapy while making it economically effective to the payer (state, local government, national health funds/insurance). The project’s outcome will be an innovative model for treatment of highly devastating disease even with the possibility of preventing highly undesirable side effects for a patient and on a macro-scale for the economy, society and pension scheme. However, in scaling-up, the Company has to identify regulatory pathways to abide even when the technology is out of scope of current regulatory landscape. New therapy means also identification of new business models. Reaching market authorization will be determined on the basis of acceptance of currently carried out academic clinical trials and any further clinical trials ordered by the EMA. Elaboration of feasibility study will allow PolTREG to prepare the necessary strategy for this regulatory requirements. Fields of science medical and health sciencesclinical medicineendocrinologydiabetesmedical and health sciencesbasic medicineimmunologyautoimmune diseasesmedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccinesmedical and health sciencesmedical biotechnologycells technologiesmedical and health sciencesclinical medicinenephrologykidney diseases Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SMEInst-05-2016-2017 - Supporting innovative SMEs in the healthcare biotechnology sector Call for proposal H2020-SMEInst-2016-2017 See other projects for this call Sub call H2020-SMEINST-1-2016-2017 Funding Scheme SME-1 - SME instrument phase 1 Coordinator POLTREG SPOLKA AKCYJNA Net EU contribution € 50 000,00 Address UL. BOTANICZNA 20 80-298 GDANSK Poland See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Makroregion północny Pomorskie Trójmiejski Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 71 429,00