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Antibodies against Nogo-A to enhance plasticity, regeneration and functional recovery after acute spinal cord injury, a multicenter European clinical proof of concept trial

Objective

Spinal cord injury is a severe and devastating neurological disorder that leaves patients with permanent paralysis of the body. No treatment is available today to regenerate interrupted nerve fibers and repair the damaged spinal cord. The incidence of spinal cord injury is about newly injured 10’000 people per year in the EU, and due to an almost normal life expectancy more than 200’000 patients are living with a spinal cord injury in the EU. The impact on the individual quality of life is high, and social costs are enormous.
Recent preclinical research in animal models succeeded to greatly enhance axonal sprouting, fiber regeneration and neuroplasticity following injuries of brain and spinal cord. These results warrant translation now to patients suffering from acute spinal cord injury. A previous phase I clinical study using intrathecal application of a nerve fiber growth promoting antibody against the growth inhibitory protein Nogo-A has shown in patients with complete spinal cord injury that this treatment is safe and well tolerated. The present study will enroll patients with various degrees of complete to incomplete acute spinal cord injury for a double-blind, placebo-controlled trial to test the efficacy of this antibody therapy to improve motor outcome and quality of life of tetraplegic patients. The enrollment of patients with different degrees of spinal cord injury is considered essential to reveal drug activity and eventual proof of concept in a broad patient population. Advancements in clinical trial design, improved prediction algorithms of clinical outcomes and development of surrogate markers (in cerebro-spinal fluid/serum and by neuroimaging) will allow for scrutinizing the effectiveness of this novel treatment in an unprecedented way. A positive outcome of this trial will represent a breakthrough for the future therapy of spinal cord injuries and beyond (traumatic brain injury, stroke, multiple sclerosis).

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2015-single-stage_RTD

Coordinator

UNIVERSITAT ZURICH
Net EU contribution
€ 75 000,00
Address
Ramistrasse 71
8006 Zurich
Switzerland

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Region
Schweiz/Suisse/Svizzera Zürich Zürich
Activity type
Higher or Secondary Education Establishments
Other funding
€ 75 000,00

Participants (14)

UNIVERSITATSKLINIKUM HEIDELBERG
Germany
Net EU contribution
€ 2 037 290,00
Address
Im Neuenheimer Feld 672
69120 Heidelberg

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Region
Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Other funding
€ 2 037 290,00
MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN EV
Germany
Net EU contribution
€ 768 647,50
Address
Hofgartenstrasse 8
80539 Munchen

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Research Organisations
Other funding
€ 768 647,50
FUNDACIO INSTITUT GUTTMANN
Spain
Net EU contribution
€ 158 717,50
Address
Cami De Can Ruti Sn
08916 Badalona

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Other funding
€ 158 717,50
FAKULTNI NEMOCNICE V MOTOLE
Czechia
Net EU contribution
€ 158 717,50
Address
V Uvalu 84
150 06 Praha 5

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Region
Praha Hlavní město Praha
Activity type
Research Organisations
Other funding
€ 158 717,50
BG KLINIKUM MURNAU GGMBH
Germany
Net EU contribution
€ 281 848,75
Address
Professor Kuentscher Strasse 8
82418 Murnau A.staffelsee

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Region
Bayern Oberbayern Garmisch-Partenkirchen
Activity type
Research Organisations
Other funding
€ 281 848,75
FONDAZIONE SANTA LUCIA
Italy
Net EU contribution
€ 166 413,75
Address
Via Ardeatina 306
00179 Roma

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Region
Centro (IT) Lazio Roma
Activity type
Research Organisations
Other funding
€ 166 413,75
KLINIKUM BAYREUTH GMBH
Germany
Net EU contribution
€ 281 848,75
Address
Preuschwitzerstrasse 101
95445 Bayreuth

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Region
Bayern Oberfranken Bayreuth, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 281 848,75
RUHR-UNIVERSITAET BOCHUM
Germany
Net EU contribution
€ 295 000,00
Address
Universitaetsstrasse 150
44801 Bochum

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Region
Nordrhein-Westfalen Arnsberg Bochum, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Other funding
€ 295 000,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 152 869,89
Address
5 Rue Watt
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 152 869,89
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

KLINIKUM DER UNIVERSITAET ZU KOELN

Participation ended

Germany
Net EU contribution
€ 3 974,11
Address
Kerpener Strasse 62
50937 Koeln
Region
Nordrhein-Westfalen Köln Köln, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Other funding
€ 3 974,11
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

Masarykova univerzita
Czechia
Net EU contribution
€ 44 000,00
Address
Zerotinovo Namesti 9
601 77 Brno

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Jihovýchod Jihomoravský kraj
Activity type
Higher or Secondary Education Establishments
Other funding
€ 44 000,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA
Spain
Net EU contribution
€ 70 492,00
Address
Carrer Rossello 149
08036 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Other funding
€ 70 492,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

KKS-NETZWERK EV -NETZWERK DER KOORDINIERUNGSZENTREN FUR KLINISCHE STUDIEN
Germany
Net EU contribution
€ 1 500,00
Address
Alt-moabit 96 A
10559 Berlin

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Region
Berlin Berlin Berlin
Activity type
Research Organisations
Other funding
€ 1 500,00
TP21 GMBH
Germany
Net EU contribution
€ 278 125,00
Address
Luisenstrasse 14
10117 Berlin

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Berlin Berlin Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 278 125,00