CORDIS
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CORDIS

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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

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.
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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)

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REHAB STATION STOCKHOLM AKTIEBOLAG

Sweden

EU Contribution

€ 1 511 125

REGION MIDTJYLLAND

Denmark

KIINTEISTO OY Laitilan Terveyskoti

Finland

EU Contribution

€ 1 125 742

REGION HOVEDSTADEN

Denmark

STOCKHOLMS LANS LANDSTING

Sweden

EU Contribution

€ 1 451 217

SIHTASUTUS HAAPSALU NEUROLOOGILINE REHABILITATSIOONIKESKUS

Estonia

EU Contribution

€ 687 931

HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL

Norway

EU Contribution

€ 968 075

Project information

Grant agreement ID: 643853

Status

Ongoing project

  • Start date

    1 January 2015

  • End date

    31 December 2019

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 13 981 411

  • EU contribution

    € 6 397 077

Coordinated by:

BIOARCTIC AB

Sweden