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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.

Field of science

  • /medical and health sciences/clinical medicine/surgery/surgical procedure
  • /engineering and technology/electrical engineering, electronic engineering, information engineering/electronic engineering/robotics

Call for proposal

H2020-PHC-2014-single-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

BIOARCTIC AB
Address
Warfvinges Vag 35
112 51 Stockholm
Sweden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 652 987

Participants (7)

REHAB STATION STOCKHOLM AKTIEBOLAG
Sweden
EU contribution
€ 1 511 125
Address
Frosundaviks Alle 13
16 970 Solna
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
REGION MIDTJYLLAND

Participation ended

Denmark
EU contribution
€ 0
Address
Skottenborg 26
8800 Viborg
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
KIINTEISTO OY Laitilan Terveyskoti
Finland
EU contribution
€ 1 125 742
Address
Sairaalantie 8
23800 Laitila
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
REGION HOVEDSTADEN

Participation ended

Denmark
EU contribution
€ 0
Address
Kongens Vaenge 2
3400 Hillerod
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
REGION STOCKHOLM
Sweden
EU contribution
€ 1 451 217
Address
Hantverkargatan 45
104 22 Stockholm
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
SIHTASUTUS HAAPSALU NEUROLOOGILINE REHABILITATSIOONIKESKUS
Estonia
EU contribution
€ 687 931
Address
Sadama 16
90502 Haapsalu
Activity type
Other
HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL
Norway
EU contribution
€ 968 075
Address
Jonas Lies Vei 65
5021 Bergen
Activity type
Higher or Secondary Education Establishments