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NISCI SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

NISCI project word cloud

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

enrollment devastating injury drug neuroplasticity algorithms outcome succeeded injured interrupted fiber axonal advancements therapy regenerate social 200 cerebro effectiveness people cord surrogate prediction degrees serum almost placebo intrathecal proof suffering eventual fluid treatment trial sclerosis spinal traumatic fibers protein preclinical injuries brain inhibitory leaves quality warrant complete efficacy sprouting breakthrough patient enroll nerve tolerated broad damaged markers paralysis life shown incomplete double animal acute regeneration severe antibody unprecedented translation body patients disorder individual outcomes tetraplegic positive incidence expectancy scrutinizing clinical repair multiple neurological normal stroke motor living population blind safe newly nogo models reveal enormous permanent neuroimaging

Project "NISCI" data sheet

The following table provides information about the project.

Coordinator	UNIVERSITAT ZURICH Organization address address: RAMISTRASSE 71 city: ZURICH postcode: 8006 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	Switzerland [CH]
Project website	http://www.nisi-2020.eu
Total cost	6˙702˙978 €
EC max contribution	4˙774˙444 € (71%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-PHC-2015-single-stage_RTD
Funding Scheme	RIA
Starting year	2016
Duration (year-month-day)	from 2016-01-01 to 2020-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	UNIVERSITAT ZURICH UNIVERSITAT ZURICH Organization address address: RAMISTRASSE 71 city: ZURICH postcode: 8006 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.	CH (ZURICH)	coordinator	75˙000.00
2	UNIVERSITATSKLINIKUM HEIDELBERG UNIVERSITATSKLINIKUM HEIDELBERG Organization address address: IM NEUENHEIMER FELD 672 city: HEIDELBERG postcode: 69120 website: www.klinikum.uni-heidelberg.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HEIDELBERG)	participant	2˙037˙290.00
3	MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN EV MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN EV Organization address address: HOFGARTENSTRASSE 8 city: MUENCHEN postcode: 80539 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.	DE (MUENCHEN)	participant	768˙647.00
4	RUHR-UNIVERSITAET BOCHUM RUHR-UNIVERSITAET BOCHUM Organization address address: UNIVERSITAETSSTRASSE 150 city: BOCHUM postcode: 44801 website: www.rub.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (BOCHUM)	participant	295˙000.00
5	BG KLINIKUM MURNAU GGMBH BG KLINIKUM MURNAU GGMBH Organization address address: PROFESSOR KUENTSCHER STRASSE 8 city: MURNAU A.STAFFELSEE postcode: 82418 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.	DE (MURNAU A.STAFFELSEE)	participant	281˙848.00
6	KLINIKUM BAYREUTH GMBH KLINIKUM BAYREUTH GMBH Organization address address: PREUSCHWITZERSTRASSE 101 city: BAYREUTH postcode: 95445 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.	DE (BAYREUTH)	participant	281˙848.00
7	TP21 GMBH TP21 GMBH Organization address address: LUISENSTRASSE 14 city: BERLIN postcode: 10117 website: www.tp21.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (BERLIN)	participant	278˙125.00
8	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	272˙836.00
9	FONDAZIONE SANTA LUCIA FONDAZIONE SANTA LUCIA Organization address address: VIA ARDEATINA 306 city: Roma postcode: 179 website: http://www.hsantalucia.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (Roma)	participant	166˙413.00
10	FAKULTNI NEMOCNICE V MOTOLE FAKULTNI NEMOCNICE V MOTOLE Organization address address: V UVALU 84 city: PRAHA 5 postcode: 150 06 website: www.fnmotol.cz contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CZ (PRAHA 5)	participant	158˙717.00
11	FUNDACIO INSTITUT GUTTMANN FUNDACIO INSTITUT GUTTMANN Organization address address: CAMI DE CAN RUTI SN city: BADALONA postcode: 8916 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.	ES (BADALONA)	participant	158˙717.00

Map

Project 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).

Publications

List of publications.
year	authors and title	journal	last update
2017	K. Barkovits, A. Linden, S. Galozzi, J. Uszkoreit, B. Mollenhauer, K. Marcus Characterization of cerebrospinal fluid via data-independent acquisition mass spectrometry published pages: 1 (Poster), ISSN: , DOI:	Proteomic Forum 2017 Annual meeting of the German Society for Proteome Research 2â€“5 April 2017	2020-03-20
2017	Georgia Minakaki, Stefanie Menges, Agnes Kittel, Evangelia Emmanouilidou, Iris Schaeffner, Katalin Barkovits, Anna Bergmann, Edward Rockenstein, Anthony Adame, Franz Marxreiter, Brit Mollenhauer, Douglas Galasko, Edit IrÃ©n BuzÃ¡s, Ursula SchlÃ¶tzer-Schrehardt, Katrin Marcus, Wei Xiang, Dieter Chichung Lie, Kostas Vekrellis, Eliezer Masliah, JÃ¼rgen Winkler, Jochen Klucken Autophagy inhibition promotes SNCA/alpha-synuclein release and transfer via extracellular vesicles with a hybrid autophagosome-exosome-like phenotype published pages: 98-119, ISSN: 1554-8627, DOI: 10.1080/15548627.2017.1395992	Autophagy 14/1	2020-03-20
2018	Eveline Huber, Gergely David, Alan J. Thompson, Nikolaus Weiskopf, Siawoosh Mohammadi, Patrick Freund Dorsal and ventral horn atrophy is associated with clinical outcome after spinal cord injury published pages: e1510-e1522, ISSN: 0028-3878, DOI: 10.1212/WNL.0000000000005361	Neurology 90/17	2020-03-20
2018	Gabriel Ziegler, Patrick Grabher, Alan Thompson, Daniel Altmann, Markus Hupp, John Ashburner, Karl Friston, Nikolaus Weiskopf, Armin Curt, Patrick Freund Progressive neurodegeneration following spinal cord injury published pages: e1257-e1266, ISSN: 0028-3878, DOI: 10.1212/WNL.0000000000005258	Neurology 90/14	2020-03-20
2018	Luke J. Edwards, Evgeniya Kirilina, Siawoosh Mohammadi, Nikolaus Weiskopf Microstructural imaging of human neocortex in vivo published pages: 184-206, ISSN: 1053-8119, DOI: 10.1016/j.neuroimage.2018.02.055	NeuroImage 182	2020-03-20
2018	Lukas M. Schilde, Steffen KÃ¶sters, Simone Steinbach, Karin Schork, Martin Eisenacher, Sara Galozzi, Michael Turewicz, Katalin Barkovits, Brit Mollenhauer, Katrin Marcus, Caroline May Protein variability in cerebrospinal fluid and its possible implications for neurological protein biomarker research published pages: e0206478, ISSN: 1932-6203, DOI: 10.1371/journal.pone.0206478	PLOS ONE 13/11	2020-03-20
2018	Maryam Seif, Armin Curt, Alan J. Thompson, Patrick Grabher, Nikolaus Weiskopf, Patrick Freund Quantitative MRI of rostral spinal cord and brain regions is predictive of functional recovery in acute spinal cord injury published pages: 556-563, ISSN: 2213-1582, DOI: 10.1016/j.nicl.2018.08.026	NeuroImage: Clinical 20	2020-03-20
2019	Sara Lorio, Tim M. Tierney, Amy McDowell, Owen J. Arthurs, Antoine Lutti, Nikolaus Weiskopf, David W. Carmichael Flexible proton density (PD) mapping using multi-contrast variable flip angle (VFA) data published pages: 464-475, ISSN: 1053-8119, DOI: 10.1016/j.neuroimage.2018.11.023	NeuroImage 186	2020-03-20
2017	S. Mohammadi, N. Weiskopf Computationale Neuroanatomie und Mikrostrukturbildgebung mit der Magnetresonanztomographie published pages: 839-849, ISSN: 0028-2804, DOI: 10.1007/s00115-017-0373-4	Der Nervenarzt 88/8	2020-03-20
2017	Robert Trampel, Pierre-Louis Bazin, Kerrin Pine, Nikolaus Weiskopf In-vivo magnetic resonance imaging (MRI) of laminae in the human cortex published pages: , ISSN: 1053-8119, DOI: 10.1016/j.neuroimage.2017.09.037	NeuroImage	2020-03-20
2018	Balteau, E.; Tabelow, K.; Ashburner, J.; Callaghan, M.; Draganski, B.; Helms, G.; Kherif, F.; Leutritz, T.; Lutti, A.; Philips, C.; Reimer, E.; Ruthotto, L.; Seif, M.; Weiskopf, N.; Ziegler, G.; Mohammadi, S. hMRI: A toolbox for using quantitative MRI in neuroscience and clinical research published pages: , ISSN: 2198-5855, DOI: 10.20347/WIAS.PREPRINT.2527	WIAS Preprint 1	2020-03-20
2016	Patrick Freund, Karl Friston, Alan J. Thompson, Klaas E. Stephan, John Ashburner, Dominik R. Bach, Zoltan Nagy, Gunther Helms, Bogdan Draganski, Siawoosh Mohammadi, Martin E. Schwab, Armin Curt, Nikolaus Weiskopf Embodied neurology: an integrative framework for neurological disorders published pages: 1855-1861, ISSN: 0006-8950, DOI: 10.1093/brain/aww076	Brain 139/6	2020-03-20
2017	Prados, Ferran; Ashburner, John; Blaiotta, Claudia; Brosch, Tom; Carballido-Gamio, Julio; Cardoso, Manuel Jorge; Conrad, Benjamin N.; Datta, Esha; DÃ¡vid, Gergely; Leener, Benjamin de; Dupont, Sara M.; Freund, Patrick; Wheeler-Kingshott, Claudia A.M.Gandini; Grussu, Francesco; Henry, Roland; Landman, Bennett A.; Ljungberg, Emil; Lyttle, Bailey; Ourselin, Sebastien; Papinutto, Nico; Saporito, Salvatore; Schlaeger, Regina; Smith, Seth A.; Summers, Paul; Tam, Roger; Yiannakas, Marios C.; Zhu, Alyssa; Cohen-Adad, Julien Spinal cord grey matter segmentation challenge published pages: , ISSN: 0346-251X, DOI: 10.5167/uzh-136397	Neuroimage, 152, 312 - 329 1	2020-03-20
2017	Eveline Huber, Patrice Lachappelle, Reto Sutter, Armin Curt, Patrick Freund Are midsagittal tissue bridges predictive of outcome after cervical spinal cord injury? published pages: 740-748, ISSN: 0364-5134, DOI: 10.1002/ana.24932	Annals of Neurology 81/5	2020-03-20
2018	Philips, C., Balteau, E., Leutritz, T., Lutti, A., Callaghan, M. F., Draganski, B., Reimer, E., Ruthotto, L., Seif, M., Weiskopf, N., Ziegler, G., Mohammadi, S., Tabelow, K. The â€œhMRI Toolboxâ€ for quantitative imaging & in vivo histology using MRI (poster) published pages: , ISSN: , DOI:		2020-03-20
2018	Balteau, E., Leutritz, T., Weiskopf, N., Reimer, E., Lutti, A., Callaghan, M. F., Mohammadi, S., Tabelow, K. *Evaluating T2 bias impact and correction strategies in quantitative proton density mapping (poster)** published pages: , ISSN: , DOI:		2020-03-20
2018	Seif, M., Leutritz, T., Samson, R. S., Curt, A., Wheeler-Kingshott, C. A. G., Freund, P., Weiskopf, N. *A multi-center study on fast full-brain quantitative multi-parameter mapping of R1, MT, and R2: Scan-rescan repeatability and inter-site reproducibility (talk)** published pages: , ISSN: , DOI:		2020-03-20
2018	Balteau, E., Leutritz, T., Lutti, A., Callaghan, M. F., Draganski, B., Philips, C., Reimer, E., Ruthotto, L., Seif, M., Weiskopf, N., Ziegler, G., Mohammadi, S., Tabelow, K. The hMRI analysis toolbox for quantitative MRI and in vivo histology using MRI (hMRI) (poster) published pages: , ISSN: , DOI:		2020-03-20

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