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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 €

EC-Contrib. €

Partnership

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Outcomes and
results

SC0806 project word cloud

Explore the words cloud of the SC0806 project. It provides you a very rough idea of what is the project "SC0806" about.

assisted device clinical dose neuroscience usa bioarctic regenerative 42 robotics sequence granted countries status efficacy vivo sc0806 subjects start opportunity later components surgery injured therapy approval ethical least single nerves screening model today injury cord denmark secure abbreviated implanted commence procedure 18 safety months inclusion functional surgical receive finland 27 2014 injuries period transplanted orphan develops nov spinal regeneration sweden university randomized nerve designated trial training rehabilitation human patients clinics biodegradable home demonstrated loaded spans sci first hospital treatment grafts karolinska interim drug complete sequences operated traumatic walking

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 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.	SE (STOCKHOLM)	coordinator	652˙987.00
2	REHAB STATION STOCKHOLM AKTIEBOLAG REHAB STATION STOCKHOLM AKTIEBOLAG Organization address address: FROSUNDAVIKS ALLE 13 city: SOLNA postcode: 16 970 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.	SE (SOLNA)	participant	1˙511˙125.00
3	REGION STOCKHOLM REGION STOCKHOLM Organization address address: HANTVERKARGATAN 45 city: STOCKHOLM postcode: 104 22 website: www.sll.se contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (STOCKHOLM)	participant	1˙451˙217.00
4	KIINTEISTO OY Laitilan Terveyskoti KIINTEISTO OY Laitilan Terveyskoti Organization address address: Sairaalantie 8 city: Laitila postcode: 23800 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.	FI (Laitila)	participant	1˙125˙742.00
5	HELSE BERGEN HFHAUKELAND UNIVERSITY HOSPITAL HELSE BERGEN HFHAUKELAND UNIVERSITY HOSPITAL Organization address address: JONAS LIES VEI 65 city: BERGEN postcode: 5021 website: http://www.helse-bergen.no/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NO (BERGEN)	participant	968˙075.00
6	SIHTASUTUS HAAPSALU NEUROLOOGILINE REHABILITATSIOONIKESKUS SIHTASUTUS HAAPSALU NEUROLOOGILINE REHABILITATSIOONIKESKUS Organization address address: SADAMA 16 city: HAAPSALU postcode: 90502 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.	EE (HAAPSALU)	participant	687˙931.00
7	REGION HOVEDSTADEN REGION HOVEDSTADEN Organization address address: KONGENS VAENGE 2 city: HILLEROD postcode: 3400 website: www.regionh.dk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (HILLEROD)	participant	0.00
8	REGION MIDTJYLLAND REGION MIDTJYLLAND Organization address address: Skottenborg 26 city: VIBORG postcode: 8800 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.	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.

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

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