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Regenerative treatment of complete Traumatic Spinal Cord injury with a surgical implantation of a biodegradable device with FGF1 and nerve grafts

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.

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2014-single-stage

Coordinator

BIOARCTIC AB
Net EU contribution
€ 652 987,00
Address
Warfvinges Vag 35
112 51 Stockholm
Sweden

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 6 148 311,50

Participants (7)

REHAB STATION STOCKHOLM AKTIEBOLAG
Sweden
Net EU contribution
€ 1 511 125,00
Address
Frosundaviks Alle 13
16 970 Solna

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 377 781,25
REGION MIDTJYLLAND

Participation ended

Denmark
Net EU contribution
€ 0,00
Address
Skottenborg 26
8800 Viborg
Region
Danmark Midtjylland Vestjylland
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
KIINTEISTO OY Laitilan Terveyskoti
Finland
Net EU contribution
€ 1 125 742,00
Address
Sairaalantie 8
23800 Laitila

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Region
Manner-Suomi Etelä-Suomi Varsinais-Suomi
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 281 435,50
REGION HOVEDSTADEN

Participation ended

Denmark
Net EU contribution
€ 0,00
Address
Kongens Vaenge 2
3400 Hillerod
Region
Danmark Hovedstaden Nordsjælland
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
REGION STOCKHOLM
Sweden
Net EU contribution
€ 1 451 217,00
Address
Hantverkargatan 45
104 22 Stockholm

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Region
Östra Sverige Stockholm Stockholms län
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 362 804,25
SIHTASUTUS HAAPSALU NEUROLOOGILINE REHABILITATSIOONIKESKUS
Estonia
Net EU contribution
€ 687 931,00
Address
Sadama 16
90502 Haapsalu

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Region
Eesti Eesti Lääne-Eesti
Activity type
Other
Other funding
€ 171 982,75
HELSE BERGEN HF
Norway
Net EU contribution
€ 968 075,00
Address
Jonas Lies Vei 65
5021 Bergen

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Region
Norge Vestlandet Vestland
Activity type
Higher or Secondary Education Establishments
Other funding
€ 242 018,75