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MIROCALS SIGNED

Efficacy and safety of low-dose IL-2 (ld-IL-2) as a Treg enhancer for anti-neuroinflammatory therapy in newly diagnosed Amyotrophic Lateral Sclerosis (ALS) patients

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

MIROCALS project word cloud

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

impasse neurodegenerative modifying cerebrospinal degenerative lateral encourage modify diseases sclerosis subsequent care damage hypothesis fatal possibilities tregs therapeutic break survival mirocals als activates il logical causing deaths proof rates model opens versus neuroprotective integrate progression function vasculitis interleukin immune players effect mechanism decreased breakthrough inflammatory pioneering individuals safely fact trial nerve showed spinal quality chronic outcome amyotrophic defective patient treg blood cord agents engineered ld graft significantly host outcomes inflammation regulatory 11 hbc diabetes industry death cell riluzole failed detected attempts predict therapy people investment disorder brain biomarkers fluid disease contributes cells life course dose discovery re ambition drug trials

Project "MIROCALS" data sheet

The following table provides information about the project.

Coordinator	CENTRE HOSPITALIER UNIVERSITAIRE Organization address address: PLACE DU PR ROBERT DEBRE city: NIMES postcode: 30900 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	France [FR]
Project website	http://www.mirocals.eu/
Total cost	6˙510˙741 €
EC max contribution	5˙980˙435 € (92%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-PHC-2014-two-stage
Funding Scheme	RIA
Starting year	2015
Duration (year-month-day)	from 2015-09-01 to 2021-09-30

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	CENTRE HOSPITALIER UNIVERSITAIRE CENTRE HOSPITALIER UNIVERSITAIRE Organization address address: PLACE DU PR ROBERT DEBRE city: NIMES postcode: 30900 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.	FR (NIMES)	coordinator	1˙448˙890.00
2	THE UNIVERSITY OF SUSSEX THE UNIVERSITY OF SUSSEX Organization address address: SUSSEX HOUSE FALMER city: BRIGHTON postcode: BN1 9RH website: http://www.sussex.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (BRIGHTON)	participant	856˙330.00
3	ICON CLINICAL RESEARCH LIMITED ICON CLINICAL RESEARCH LIMITED Organization address address: SOUTH COUNTY BUSINESS PARK LEOPARDSTOWN city: DUBLIN postcode: 18 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.	IE (DUBLIN)	participant	659˙105.00
4	THE UNIVERSITY OF SHEFFIELD THE UNIVERSITY OF SHEFFIELD Organization address address: FIRTH COURT WESTERN BANK city: SHEFFIELD postcode: S10 2TN website: www.shef.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (SHEFFIELD)	participant	504˙408.00
5	KING'S COLLEGE LONDON KING'S COLLEGE LONDON Organization address address: STRAND city: LONDON postcode: WC2R 2LS website: www.kcl.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	490˙790.00
6	WGK CONSULTANCY LTD WGK CONSULTANCY LTD Organization address address: 29 SISH LANE city: STEVENAGE postcode: SG1 3LS 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.	UK (STEVENAGE)	participant	476˙650.00
7	HUMANITAS MIRASOLE SPA HUMANITAS MIRASOLE SPA Organization address address: VIA MANZONI 56 city: ROZZANO (MI) postcode: 20100 website: www.humanitas.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 (ROZZANO (MI))	participant	450˙000.00
8	INSERM - TRANSFERT SA INSERM - TRANSFERT SA Organization address address: RUE WATT 7 city: PARIS postcode: 75013 website: www.inserm-transfert.fr 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	421˙000.00
9	ASSOCIATION GENETHON ASSOCIATION GENETHON Organization address address: RUE DE L INTERNATIONALE 1 BIS city: EVRY postcode: 91002 website: www.genethon.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (EVRY)	participant	373˙622.00
10	QUEEN MARY UNIVERSITY OF LONDON QUEEN MARY UNIVERSITY OF LONDON Organization address address: 327 MILE END ROAD city: LONDON postcode: E1 4NS website: http://www.qmul.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	159˙138.00
11	GOETEBORGS UNIVERSITET GOETEBORGS UNIVERSITET Organization address address: VASAPARKEN city: GOETEBORG postcode: 405 30 website: www.gu.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 (GOETEBORG)	participant	140˙500.00
12	MOTOR NEURONE DISEASE ASSOCIATION MOTOR NEURONE DISEASE ASSOCIATION Organization address address: 10 15 NOTRE DAME MEWS city: NORTHAMPTON postcode: NN1 2BG 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.	UK (NORTHAMPTON)	participant	0.00

Map

Project objective

Amyotrophic Lateral Sclerosis (ALS) is a fatal degenerative disorder of the brain and spinal cord affecting some 40,000 individuals in Europe, causing 11,000 deaths each year. Our pioneering work on riluzole showed that it is possible to modify ALS progression but all subsequent trials of potential neuroprotective agents have failed. Thus, drug development in ALS, including trial design, patient selection, and outcome measures must be re-engineered to break the current impasse. Nerve cell death in ALS is associated with inflammation, which contributes to cell damage, and is a logical target for therapy. Although therapeutic attempts to modify this have failed so far, the discovery of regulatory T cells (Tregs) as key players in controlling inflammatory processes opens new possibilities since defective Treg function is important in ALS. In fact, Treg numbers and function predict rates of disease progression and survival. Low-dose interleukin-2 (ld IL-2) safely and specifically increases and activates Tregs in conditions such as type 1 diabetes, HBc-vasculitis and chronic graft-versus-host disease, so ld IL-2 has the potential to significantly improve survival and deliver a therapeutic breakthrough in ALS. We also integrate biomarkers for nerve cell damage into the trial design to provide proof of concept/mechanism. “Modifying Immune Response and OutComes in ALS” (MIROCALS) will test the hypothesis that ld IL-2-induced increases in Tregs result in decreased rates of nerve cell damage and that this effect can be detected early in the course of the disease using a range of blood and cerebrospinal fluid biomarkers. Our ambition is to develop a new therapy for ALS and through this novel trial design break the impasse in drug development of other disease-modifying agents in ALS. The impact will be to enhance quality of life and care for people with ALS, and provide a robust model for Industry to encourage investment in ALS and other neurodegenerative diseases.

Deliverables

List of deliverables.
Approval from IRBs and Regulatory Agencies	Documents, reports	2020-02-17 17:47:48
Corporate communication tools provided	Demonstrators, pilots, prototypes	2020-02-17 17:47:48

Take a look to the deliverables list in detail: detailed list of MIROCALS deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2019	Jeremy A. Garson, Louise Usher, Ammar Al-Chalabi, Jim Huggett, Edmund F. Day, Adele L. McCormick Quantitative analysis of human endogenous retrovirus-K transcripts in postmortem premotor cortex fails to confirm elevated expression of HERV-K RNA in amyotrophic lateral sclerosis published pages: , ISSN: 2051-5960, DOI: 10.1186/s40478-019-0698-2	Acta Neuropathologica Communications 7/1	2020-04-15
2018	Jason A. Chen, Zhongbo Chen, Hyejung Won, Alden Y. Huang, Jennifer K. Lowe, Kevin Wojta, Jennifer S. Yokoyama, Gilbert Bensimon, P. Nigel Leigh, Christine Payan, Aleksey Shatunov, Ashley R. Jones, Cathryn M. Lewis, Panagiotis Deloukas, Philippe Amouyel, Christophe Tzourio, Jean-Francois Dartigues, Albert Ludolph, Adam L. Boxer, Jeff M. Bronstein, Ammar Al-Chalabi, Daniel H. Geschwind, Giovanni Cop Joint genome-wide association study of progressive supranuclear palsy identifies novel susceptibility loci and genetic correlation to neurodegenerative diseases published pages: , ISSN: 1750-1326, DOI: 10.1186/s13024-018-0270-8	Molecular Neurodegeneration 13/1	2020-02-17
2017	Sarah Morgan, Aleksey Shatunov, William Sproviero, Ashley R. Jones, Maryam Shoai, Deborah Hughes, Ahmad Al Khleifat, Andrea Malaspina, Karen E. Morrison, Pamela J. Shaw, Christopher E. Shaw, Katie Sidle, Richard W. Orrell, Pietro Fratta, John Hardy, Alan Pittman, Ammar Al-Chalabi A comprehensive analysis of rare genetic variation in amyotrophic lateral sclerosis in the UK published pages: 1611-1618, ISSN: 0006-8950, DOI: 10.1093/brain/awx082	Brain 140/6	2020-02-17
2016	Janine Kirby, Afnan Al Sultan, Rachel Waller, Paul Heath The genetics of amyotrophic lateral sclerosis: current insights published pages: 49, ISSN: 1179-9900, DOI: 10.2147/dnnd.s84956	Degenerative Neurological and Neuromuscular Disease	2020-02-17
2018	Martina de Majo, Simon D. Topp, Bradley N. Smith, Agnes L. Nishimura, Han-Jou Chen, Athina Soragia Gkazi, Jack Miller, Chun Hao Wong, Caroline Vance, Frank Baas, Anneloor L.M.A. ten Asbroek, Kevin P. Kenna, Nicola Ticozzi, Alberto Garcia Redondo, JesÃºs Esteban-PÃ©rez, Cinzia Tiloca, Federico Verde, Stefano Duga, Karen E. Morrison, Pamela J. Shaw, Janine Kirby, Martin R. Turner, Kevin Talbot, Orla ALS-associated missense and nonsense TBK1 mutations can both cause loss of kinase function published pages: 266.e1-266.e10, ISSN: 0197-4580, DOI: 10.1016/j.neurobiolaging.2018.06.015	Neurobiology of Aging 71	2020-02-17
2017	Sarah Martin, Emma Trevor-Jones, Sabyha Khan, Keelan Shaw, Deepti Marchment, Anna Kulka, Catherine E Ellis, Rachel Burman, Martin R. Turner, Liam Carroll, Leah Mursaleen, P. Nigel Leigh, Christopher E. Shaw, Neil Pearce, Daniel Stahl, Ammar Al-Chalabi The benefit of evolving multidisciplinary care in ALS: a diagnostic cohort survival comparison published pages: 569-575, ISSN: 2167-8421, DOI: 10.1080/21678421.2017.1349151	Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18/7-8	2020-02-17
2017	Alice Vajda, Russell L. McLaughlin, Mark Heverin, Owen Thorpe, Sharon Abrahams, Ammar Al-Chalabi, Orla Hardiman Genetic testing in ALS published pages: 991-999, ISSN: 0028-3878, DOI: 10.1212/WNL.0000000000003686	Neurology 88/10	2020-02-17
2017	Egor Dolzhenko, Joke J.F.A. van Vugt, Richard J. Shaw, Mitchell A. Bekritsky, Marka van Blitterswijk, Giuseppe Narzisi, Subramanian S. Ajay, Vani Rajan, Bryan R. Lajoie, Nathan H. Johnson, Zoya Kingsbury, Sean J. Humphray, Raymond D. Schellevis, William J. Brands, Matt Baker, Rosa Rademakers, Maarten Kooyman, Gijs H.P. Tazelaar, Michael A. van Es, Russell McLaughlin, William Sproviero, Aleksey Sha Detection of long repeat expansions from PCR-free whole-genome sequence data published pages: 1895-1903, ISSN: 1088-9051, DOI: 10.1101/gr.225672.117	Genome Research 27/11	2020-02-17
2017	Zhongbo Chen, Kuang Lin, Jeffrey D. Macklis, Ammar Al-Chalabi Proposed association between the hexanucleotide repeat of C9orf72 and opposability index of the thumb published pages: 175-181, ISSN: 2167-8421, DOI: 10.1080/21678421.2016.1257024	Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18/3-4	2020-02-17
2018	Ton Fang, Ahmad Al Khleifat, Jacques-Henri Meurgey, Ashley Jones, P Nigel Leigh, Gilbert Bensimon, Ammar Al-Chalabi Stage at which riluzole treatment prolongs survival in patients with amyotrophic lateral sclerosis: a retrospective analysis of data from a dose-ranging study published pages: 416-422, ISSN: 1474-4422, DOI: 10.1016/S1474-4422(18)30054-1	The Lancet Neurology 17/5	2020-02-17

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