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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

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).
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Coordinator

UNIVERSITAT ZURICH

Address

Ramistrasse 71
8006 Zurich

Switzerland

Activity type

Higher or Secondary Education Establishments

Participants (10)

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UNIVERSITATSKLINIKUM HEIDELBERG

Germany

EU Contribution

€ 2 037 290

MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN EV

Germany

EU Contribution

€ 843 647,50

FUNDACIO INSTITUT GUTTMANN

Spain

EU Contribution

€ 158 717,50

FAKULTNI NEMOCNICE V MOTOLE

Czechia

EU Contribution

€ 158 717,50

BG KLINIKUM MURNAU GGMBH

Germany

EU Contribution

€ 281 848,75

FONDAZIONE SANTA LUCIA

Italy

EU Contribution

€ 166 413,75

KLINIKUM BAYREUTH GMBH

Germany

EU Contribution

€ 281 848,75

RUHR-UNIVERSITAET BOCHUM

Germany

EU Contribution

€ 295 000

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 272 836

TP21 GMBH

Germany

EU Contribution

€ 278 125

Project information

Grant agreement ID: 681094

Status

Ongoing project

  • Start date

    1 January 2016

  • End date

    31 December 2020

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 6 702 978,50

  • EU contribution

    € 4 774 444,75

Coordinated by:

UNIVERSITAT ZURICH

Switzerland