MERLIN

MEsenchymal stem cells to Reduce Liver INflammation

Coordinatore	THE UNIVERSITY OF BIRMINGHAM    more  Organization address address: Edgbaston city: BIRMINGHAM postcode: B15 2TT contact info Titolo: Ms. Nome: May Cognome: Chung Email: send email Telefono: 441214000000 Fax: 441214000000
Nazionalità Coordinatore	United Kingdom [UK]
Totale costo	7˙026˙727 €
EC contributo	5˙382˙958 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2013-INNOVATION-1
Funding Scheme	CP-FP
Anno di inizio	2014
Periodo (anno-mese-giorno)	2014-02-01   -   2018-01-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	THE UNIVERSITY OF BIRMINGHAM  Organization address address: Edgbaston city: BIRMINGHAM postcode: B15 2TT contact info Titolo: Ms. Nome: May Cognome: Chung Email: send email Telefono: 441214000000 Fax: 441214000000	UK (BIRMINGHAM)	coordinator	1˙624˙439.00
2	ORBSEN THERAPEUTICS LIMITED  Organization address address: ORBSEN BUILDING NATIONAL UNIVERSITY OF IRELAND city: GALWAY contact info Titolo: Dr. Nome: Stephen Cognome: Elliman Email: send email Telefono: +353 86 0285113	IE (GALWAY)	participant	931˙516.00
3	ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM  Organization address address: 's Gravendijkwal 230 city: ROTTERDAM postcode: 3015CE contact info Titolo: Dr. Nome: Carla Cognome: Baan Email: send email Telefono: +31 107038293 Fax: +31 10 7044718	NL (ROTTERDAM)	participant	732˙850.00
4	NHS BLOOD AND TRANSPLANT  Organization address address: OAK HOUSE REEDS CRESCENT city: WATFORD postcode: WD24 4QN contact info Titolo: Dr. Nome: Daniel Cognome: Hollyman Email: send email Telefono: +44 01179757575 Fax: +0121 278 4149	UK (WATFORD)	participant	682˙172.00
5	BIOINVISION INC  Organization address address: BETA DRIVE 781 STE E city: MAYFIELD VILLAGE OH postcode: 44143 contact info Titolo: Dr. Nome: Debashish Cognome: Roy Email: send email Telefono: +1 2163731500 Fax: +1 2162019375	US (MAYFIELD VILLAGE OH)	participant	549˙031.00
6	UNIVERSITA DEGLI STUDI DI PADOVA  Organization address address: VIA 8 FEBBRAIO 2 city: PADOVA postcode: 35122 contact info Titolo: Ms. Nome: Luisa Cognome: Caldon Email: send email Telefono: 390498000000	IT (PADOVA)	participant	370˙105.84
7	PINTAIL LTD  Organization address address: SPRINGHILL AVENUE 77 city: BLACKROCK contact info Titolo: Mr. Nome: Ciaran Cognome: Clissmann Email: send email Telefono: +353 12899529	IE (BLACKROCK)	participant	327˙200.00
8	FONDAZIONE HUMANITAS PER LA RICERCA  Organization address address: Via Manzoni 56 city: ROZZANO postcode: 20089 contact info Titolo: Dr. Nome: Danilo Cognome: Petroni Email: send email Telefono: +39 282242435	IT (ROZZANO)	participant	165˙644.16
9	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE  Organization address address: The Old Schools, Trinity Lane city: CAMBRIDGE postcode: CB2 1TN contact info Titolo: Ms. Nome: Renata Cognome: Schaeffer Email: send email Telefono: 441223000000 Fax: 441223000000	UK (CAMBRIDGE)	participant	0.00

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 Obiettivo del progetto (Objective)

'Prevalence of liver disease is c6% (29 million people) in the EU with mortality rates from chronic liver diseases estimated at 14.3 per 100.000 in the EU-25 in 2004. Most liver diseases have a significant inflammatory component that underpins liver damage and fibrogenesis, yet current therapies have limited effectiveness. Safe novel anti-inflammatory therapies would satisfy a large unmet need for inflammatory liver conditions such as primary sclerosing cholangitis (PSC). Mesenchymal Stromal Cells (MSC) are a mixed population of plastic-adherent (PA) cells isolated from bone marrow, umbilical cord and adipose tissue. Preclinical studies show that intravenous administration of PA-MSC reduces liver inflammation/damage, however only one MSC-based clinical study has been reported to date. MERLIN will examine if MSC can safely reduce biliary damage in mouse models followed by a clinical study in patients with PSC. We have identified an antibody (S2) that isolates comparable MSC from human & mouse marrow, enabling testing of pure functionally distinct cell S2 & S2- and PA-MSC populations. We will use the world’s first GMP-compliant non-bead-based cell sorter to select S2 MSC to comply with future therapeutic regulatory requirements. MERLIN partners will use novel methods to enhance MSC efficacy in PSC - by reducing immune clearance of MSC & by promoting MSC functionality & localisation in vivo. We will assess if MSC sub-sets exert differing levels of control upon liver inflammation in pre-clinical models, as well as defining their proliferation and mechanism of action. We will develop entirely novel biomarkers for PSC within the disease pathway pre and post cell infusion. The optimal combination of MSC sub-set and “efficacy enhancement”, will be selected for progression to a Phase 2 clinical safety study in patients with PSC. MERLIN will deliver a comprehensive data-set on optimised purified MSC and their efficacy/safety in pre-clinical models prior to a clinical trial in patients with PSC.'