Objective Today there is no regenerative therapy available for treatment of complete spinal cord injuries (SCI). BioArctic Neuroscience develops a novel treatment of complete SCI. The method is based on the regeneration of functional nerves in the injured spinal cord. Nerve grafts are transplanted into the injured spinal cord, by using a biodegradable device, loaded with a growth factor and nerve grafts (these three components are abbreviated SC0806). Efficacy and safety of the treatment has been demonstrated in an in vivo model of SCI. The therapy has been designated Orphan Drug status in Europe and in USA. Ethical approval to commence into clinical trial in Sweden was recently granted.The proposed project is the first clinical trial of the treatment of complete spinal cord injury. Following surgery at the Karolinska University Hospital, patients will receive rehabilitation in their home countries, with state of the art robotics equipment, at clinics in Denmark, Finland and Sweden. This clinical study will be the first in-human trial with this new treatment concept. Several interim analyses are included in the study design to secure the safety of the patients. This is a single dose study in up to 3 sequences (A, B and C) in 27 subjects with complete traumatic SCI. In the first sequence (A), 6 subjects will be randomized to a surgical procedure where SC0806 will be implanted at the spinal cord, and receive robotics assisted walking training for 18 months, and 3 subjects will be randomized to specific walking training only. For safety reasons, the first three subjects will be operated on and implanted with at least 1 month in between. If efficacy is demonstrated, control subjects from (A) and (B) and (C) will later be given the opportunity to receive treatment with SC0806.The proposed project spans a period of 42 months and will start nov 2014 with screening, inclusion and treatment of patients in Sweden. Fields of science natural sciencesbiological sciencesneurobiologymedical and health sciencesclinical medicinephysiotherapymedical and health sciencesclinical medicinesurgerysurgical proceduresengineering and technologyelectrical engineering, electronic engineering, information engineeringelectronic engineeringroboticsmedical and health sciencesmedical biotechnologyimplants 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) PHC-15-2014 - Clinical research on regenerative medicine Call for proposal H2020-PHC-2014-2015 See other projects for this call Sub call H2020-PHC-2014-single-stage Funding Scheme RIA - Research and Innovation action Coordinator BIOARCTIC AB Net EU contribution € 652 987,00 Address Warfvinges vag 35 112 51 Stockholm Sweden 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 Östra Sverige Stockholm Stockholms län 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 Other funding € 6 148 311,50 Participants (7) Sort alphabetically Sort by Net EU contribution Expand all Collapse all REHAB STATION STOCKHOLM AKTIEBOLAG Sweden Net EU contribution € 1 511 125,00 Address Frosundaviks alle 13 16 970 Solna See on map Region Östra Sverige Stockholm Stockholms län 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 Other funding € 377 781,25 REGION MIDTJYLLAND Participation ended Denmark Net EU contribution € 0,00 Address Skottenborg 26 8800 Viborg See on map Region Danmark Midtjylland Vestjylland Activity type Public bodies (excluding Research Organisations and Secondary or Higher 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 Other funding € 0,00 KIINTEISTO OY Laitilan Terveyskoti Finland Net EU contribution € 1 125 742,00 Address Sairaalantie 8 23800 Laitila See on map Region Manner-Suomi Etelä-Suomi Varsinais-Suomi 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 Other funding € 281 435,50 REGION HOVEDSTADEN Participation ended Denmark Net EU contribution € 0,00 Address Kongens vaenge 2 3400 Hillerod See on map Region Danmark Hovedstaden Nordsjælland Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 REGION STOCKHOLM Sweden Net EU contribution € 1 451 217,00 Address Hantverkargatan 45 104 22 Stockholm See on map Region Östra Sverige Stockholm Stockholms län Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 362 804,25 SIHTASUTUS HAAPSALU NEUROLOOGILINE REHABILITATSIOONIKESKUS Estonia Net EU contribution € 687 931,00 Address Sadama 16 90502 Haapsalu See on map Region Eesti Eesti Lääne-Eesti Activity type Other 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 Other funding € 171 982,75 HELSE BERGEN HF Norway Net EU contribution € 968 075,00 Address Jonas lies vei 65 5021 Bergen See on map Region Norge Vestlandet Vestland Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 242 018,75
