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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).

Field of science

  • /engineering and technology/materials engineering/fibers
  • /medical and health sciences/basic medicine/neurology/multiple sclerosis

Call for proposal

H2020-PHC-2015-single-stage_RTD
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITAT ZURICH
Address
Ramistrasse 71
8006 Zurich
Switzerland
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 75 000

Participants (10)

UNIVERSITATSKLINIKUM HEIDELBERG
Germany
EU contribution
€ 2 037 290
Address
Im Neuenheimer Feld 672
69120 Heidelberg
Activity type
Higher or Secondary Education Establishments
MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN EV
Germany
EU contribution
€ 768 647,50
Address
Hofgartenstrasse 8
80539 Muenchen
Activity type
Research Organisations
FUNDACIO INSTITUT GUTTMANN
Spain
EU contribution
€ 158 717,50
Address
Cami De Can Ruti Sn
08916 Badalona
Activity type
Research Organisations
FAKULTNI NEMOCNICE V MOTOLE
Czechia
EU contribution
€ 158 717,50
Address
V Uvalu 84
150 06 Praha 5
Activity type
Research Organisations
BG KLINIKUM MURNAU GGMBH
Germany
EU contribution
€ 281 848,75
Address
Professor Kuentscher Strasse 8
82418 Murnau A.staffelsee
Activity type
Research Organisations
FONDAZIONE SANTA LUCIA
Italy
EU contribution
€ 166 413,75
Address
Via Ardeatina 306
00179 Roma
Activity type
Research Organisations
KLINIKUM BAYREUTH GMBH
Germany
EU contribution
€ 281 848,75
Address
Preuschwitzerstrasse 101
95445 Bayreuth
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
RUHR-UNIVERSITAET BOCHUM
Germany
EU contribution
€ 295 000
Address
Universitaetsstrasse 150
44801 Bochum
Activity type
Higher or Secondary Education Establishments
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 272 836
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
TP21 GMBH
Germany
EU contribution
€ 278 125
Address
Luisenstrasse 14
10117 Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)