Obiettivo 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. Campo scientifico 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 Programma(i) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Argomento(i) SMEInst-05-2016-2017 - Supporting innovative SMEs in the healthcare biotechnology sector Invito a presentare proposte H2020-SMEInst-2016-2017 Vedi altri progetti per questo bando Bando secondario H2020-SMEINST-1-2016-2017 Meccanismo di finanziamento SME-1 - SME instrument phase 1 Coordinatore POLTREG SPOLKA AKCYJNA Contribution nette de l'UE € 50 000,00 Indirizzo UL. BOTANICZNA 20 80-298 GDANSK Polonia Mostra sulla mappa PMI L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione. Sì Regione Makroregion północny Pomorskie Trójmiejski Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Partecipazione a programmi di R&I dell'UE Opens in new window Rete di collaborazione HORIZON Opens in new window Costo totale € 71 429,00