Opendata, web and dolomites

SC0806 SIGNED

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

Total Cost €

0

EC-Contrib. €

0

Partnership

0

Views

0

Project "SC0806" data sheet

The following table provides information about the project.

Coordinator
BIOARCTIC AB 

Organization address
address: WARFVINGES VAG 35
city: STOCKHOLM
postcode: 112 51
website: n.a.

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Sweden [SE]
 Project website https://clinicaltrials.gov/ct2/results
 Total cost 13˙981˙411 €
 EC max contribution 6˙397˙077 € (46%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-PHC-2014-single-stage
 Funding Scheme RIA
 Starting year 2015
 Duration (year-month-day) from 2015-01-01   to  2019-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    BIOARCTIC AB SE (STOCKHOLM) coordinator 652˙987.00
2    REHAB STATION STOCKHOLM AKTIEBOLAG SE (SOLNA) participant 1˙511˙125.00
3    REGION STOCKHOLM SE (STOCKHOLM) participant 1˙451˙217.00
4    KIINTEISTO OY Laitilan Terveyskoti FI (Laitila) participant 1˙125˙742.00
5    HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL NO (BERGEN) participant 968˙075.00
6    SIHTASUTUS HAAPSALU NEUROLOOGILINE REHABILITATSIOONIKESKUS EE (HAAPSALU) participant 687˙931.00
7    REGION HOVEDSTADEN DK (HILLEROD) participant 0.00
8    REGION MIDTJYLLAND DK (VIBORG) participant 0.00

Map

 Project 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.

Are you the coordinator (or a participant) of this project? Plaese send me more information about the "SC0806" project.

For instance: the website url (it has not provided by EU-opendata yet), the logo, a more detailed description of the project (in plain text as a rtf file or a word file), some pictures (as picture files, not embedded into any word file), twitter account, linkedin page, etc.

Send me an  email (fabio@fabiodisconzi.com) and I put them in your project's page as son as possible.

Thanks. And then put a link of this page into your project's website.

The information about "SC0806" are provided by the European Opendata Portal: CORDIS opendata.

More projects from the same programme (H2020-EU.3.1.3.)

PanCareFollowUp (2019)

PanCareFollowUp: Novel, patient-centred survivorship care to improve care quality, effectiveness, cost-effectiveness and accessibility for survivors and caregivers

Read More  

LEGACy (2019)

CeLac and European consortium for a personalized medicine approach to Gastric Cancer

Read More  

HAP2 (2020)

Host-targeted Approaches for the Prevention and the treatment of Hospital-Acquired Pneumonia

Read More