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NEPHSTROM SIGNED

Novel Stromal Cell Therapy for Diabetic Kidney Disease

Total Cost €

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EC-Contrib. €

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Partnership

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 NEPHSTROM project word cloud

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

single    tolerability    risk    nephstrom    conventional    action    cell    progresses    simultaneously    gt    mortality    enabler    stromal    adherent    impacts    delivers    conduct    enormous    plastic    pharmacotherapy    transplantation    costly    critically    2040    cd362msc    characterisation    stage    halting    improves    outcomes    toward    trials    superior    animals    inform    disease    placebo    dose    therapy    efficacy    clinical    name    mechanisms    adverse    500    dialysis    trial    dkd    purity    communicable    treatments    people    msc    filtration    orbcel    chronic    adults    infusion    stabilization    stabilising    secondary    immunological    demonstrated    mesenchymal    reduce    type    protection    progression    benefit    hyperglycaemia    economic    kidney    2a    versus    diabetic    rate    albuminuria    socioeconomic    safety    function    progressive    subsequent    diabetes    allogeneic    complications    frequently    optimal    1b    benefits    renal    generation    centre    limited    population    mainstay    trade    bio    million    investigators    intravenous    generate    ancillary    preliminary    glomerular   

Project "NEPHSTROM" data sheet

The following table provides information about the project.

Coordinator
NATIONAL UNIVERSITY OF IRELAND GALWAY 

Organization address
address: UNIVERSITY ROAD
city: Galway
postcode: H91
website: www.nuigalway.ie

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 Ireland [IE]
 Project website http://nephstrom.eu
 Total cost 5˙994˙373 €
 EC max contribution 5˙994˙373 € (100%)
 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 2015-05-01   to  2020-10-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    NATIONAL UNIVERSITY OF IRELAND GALWAY IE (Galway) coordinator 1˙367˙830.00
2    TERUMO BCT EUROPE NV BE (ZAVENTEM) participant 599˙812.00
3    ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI IT (MILANO) participant 547˙902.00
4    AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII IT (BERGAMO) participant 546˙472.00
5    ACADEMISCH ZIEKENHUIS LEIDEN NL (LEIDEN) participant 523˙568.00
6    NHS BLOOD AND TRANSPLANT UK (WATFORD) participant 450˙000.00
7    UNIVERSITY HOSPITAL BIRMINGHAM NHS FOUNDATION TRUST UK (BIRMINGHAM) participant 431˙875.00
8    BELFAST HEALTH AND SOCIAL CARE TRUST UK (BELFAST) participant 415˙000.00
9    ORBSEN THERAPEUTICS LIMITED IE (Galway) participant 396˙912.00
10    LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN DE (MUENCHEN) participant 365˙000.00
11    PINTAIL LTD IE (Blackrock) participant 200˙000.00
12    THE QUEEN'S UNIVERSITY OF BELFAST UK (BELFAST) participant 150˙000.00

Map

Leaflet | Map data © OpenStreetMap contributors, CC-BY-SA, Imagery © Mapbox

 Project objective

Type 2 diabetes will affect >500 million adults by 2040 and its secondary complications will generate enormous socioeconomic costs - in particular, diabetic kidney disease (DKD), which is already the most common cause of chronic kidney disease. DKD is associated with greatly increased mortality and frequently progresses to end stage renal failure. Pharmacotherapy, dialysis and transplantation represent the mainstay treatments for DKD but are costly and provide only limited protection against adverse outcomes. Mesenchymal Stromal Cell (MSC) therapy is a promising approach to halting the progression of DKD toward end-stage renal failure and may also have ancillary benefits in Type 2 diabetes. In preliminary research, we have demonstrated that a single dose of MSC simultaneously improves kidney function (glomerular filtration rate and albuminuria) as well as hyperglycaemia in animals with DKD. NEPHSTROM will conduct a multi-centre, placebo-controlled clinical trial of a novel MSC therapy for stabilization of progressive DKD, leading to superior clinical outcomes and long-term socioeconomic benefit. A key enabler for this trial is a novel MSC population (CD362MSC, trade name ORBCEL-M) which delivers higher purity and improved characterisation compared to conventional plastic-adherent MSC. The NEPHSTROM Phase 1b/2a clinical trial will investigate the safety, tolerability and preliminary efficacy of a single intravenous infusion of allogeneic ORBCEL-M versus placebo in adults with progressive DKD. NEPHSTROM investigators will also determine the bio-distribution, mechanisms of action, immunological effects and economic impacts associated with ORBCEL-M therapy for DKD. This research will critically inform the optimal design of subsequent Phase 3 trials of ORBCEL-M. Stabilising progressive DKD through NEPHSTROM’s next-generation MSC therapy will reduce the high all-cause mortality and end-stage renal failure risk in people with this chronic non-communicable disease

 Deliverables

List of deliverables.
Website Websites, patent fillings, videos etc. 2020-01-24 09:01:41
Dissemination materials Websites, patent fillings, videos etc. 2020-01-24 09:01:41

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

 Publications

year authors and title journal last update
List of publications.
2019 Manuel Alfredo Podestà, Giuseppe Remuzzi, Federica Casiraghi
Mesenchymal Stromal Cells for Transplant Tolerance
published pages: , ISSN: 1664-3224, DOI: 10.3389/fimmu.2019.01287
Frontiers in Immunology 10 2020-01-24
2018 Nga T. Q. Nguyen, Paul Cockwell, Alexander P. Maxwell, Matthew Griffin, Timothy O’Brien, Ciaran O’Neill
Chronic kidney disease, health-related quality of life and their associated economic burden among a nationally representative sample of community dwelling adults in England
published pages: e0207960, ISSN: 1932-6203, DOI: 10.1371/journal.pone.0207960
PLOS ONE 13/11 2020-01-24
2018 Siobhan M. Hamon, Tomás P. Griffin, Md Nahidul Islam, Deirdre Wall, Matthew D. Griffin, Paula M. O’Shea
Defining reference intervals for a serum growth differentiation factor-15 (GDF-15) assay in a Caucasian population and its potential utility in diabetic kidney disease (DKD)
published pages: , ISSN: 1434-6621, DOI: 10.1515/cclm-2018-0534
Clinical Chemistry and Laboratory Medicine (CCLM) 0/0 2020-01-24
2018 A. Liew, C. Baustian, D. Thomas, E. Vaughan, C. Sanz-Nogués, M. Creane, X. Chen, S. Alagesan, P. Owens, J. Horan, P. Dockery, M. D. Griffin, A. Duffy, T. O’Brien
Allogeneic Mesenchymal Stromal Cells (MSCs) are of Comparable Efficacy to Syngeneic MSCs for Therapeutic Revascularization in C57BKSdb/db Mice Despite the Induction of Alloantibody
published pages: 96368971878486, ISSN: 0963-6897, DOI: 10.1177/0963689718784862
Cell Transplantation 2020-01-24
2019 Tomás Griffin, Md Islam, Liam Blake, Marcia Bell, Matthew Griffin, Paula O’Shea
Effect of Sodium Glucose Co-Transporter-2 Inhibition on the Aldosterone/Renin Ratio in Type 2 Diabetes Mellitus
published pages: 91-99, ISSN: 0018-5043, DOI: 10.1055/a-0794-7026
Hormone and Metabolic Research 51/02 2020-01-24
2018 Norberto Perico, Federica Casiraghi, Giuseppe Remuzzi
Clinical Translation of Mesenchymal Stromal Cell Therapies in Nephrology
published pages: 362-375, ISSN: 1046-6673, DOI: 10.1681/ASN.2017070781
Journal of the American Society of Nephrology 29/2 2020-01-24
2018 Muhammad Mosaraf Hossain, David Barua, Vahid Arabkari, Nahidul Islam, Ananya Gupta, Sanjeev Gupta
Hyperactivation of nuclear receptor coactivators induces PERK-dependent cell death
published pages: , ISSN: 1949-2553, DOI: 10.18632/oncotarget.24451
Oncotarget 9/14 2020-01-24
2018 Eanna P Connaughton, Serika Naicker, Shirley A Hanley, Stephanie M Slevin, John K Eykelenboom, Noel F Lowndes, Timothy O\'Brien, Rhodri Ceredig, Matthew D Griffin, Michael C Dennedy
Phenotypic and functional heterogeneity of human intermediate monocytes based on HLA-DR expression
published pages: , ISSN: 0818-9641, DOI: 10.1111/imcb.12032
Immunology and Cell Biology 2020-01-24
2018 Paul Lohan, Oliver Treacy, Maurice Morcos, Ellen Donohoe, Yvonne O\'donoghue, Aideen E. Ryan, Stephen J. Elliman, Thomas Ritter, Matthew D. Griffin
Interspecies Incompatibilities Limit the Immunomodulatory Effect of Human Mesenchymal Stromal Cells in the Rat
published pages: , ISSN: 1066-5099, DOI: 10.1002/stem.2840
STEM CELLS 2020-01-24
2017 William P. Martin, Tomás P. Griffin, David W. Lappin, Damian G. Griffin, John P. Ferguson, Timothy O\'Brien, Matthew D. Griffin
Influence of Referral to a Combined Diabetology and Nephrology Clinic on Renal Functional Trends and Metabolic Parameters in Adults With Diabetic Kidney Disease
published pages: 150-160, ISSN: 2542-4548, DOI: 10.1016/j.mayocpiqo.2017.07.003
Mayo Clinic Proceedings: Innovations, Quality & Outcomes 1/2 2020-01-24
2018 Norberto Perico, Federica Casiraghi, Giuseppe Remuzzi
Mesenchymal Stromal Cells for AKI after Cardiac Surgery
published pages: ASN.2017111207, ISSN: 1046-6673, DOI: 10.1681/ASN.2017111207
Journal of the American Society of Nephrology 2020-01-24
2018 Senthilkumar Alagesan, Clara Sanz-Nogués, Xizhe Chen, Michael Creane, Thomas Ritter, Rhodri Ceredig, Timothy O\'Brien, Matthew D Griffin
Anti-donor antibody induction following intramuscular injections of allogeneic mesenchymal stromal cells
published pages: 536-548, ISSN: 0818-9641, DOI: 10.1111/imcb.12024
Immunology and Cell Biology 96/5 2020-01-24
2016 Onkar P. Kulkarni, Julia Lichtnekert, Hans-Joachim Anders, Shrikant R. Mulay
The Immune System in Tissue Environments Regaining Homeostasis after Injury: Is “Inflammation” Always Inflammation?
published pages: 1-9, ISSN: 0962-9351, DOI: 10.1155/2016/2856213
Mediators of Inflammation 2016 2020-01-24
2017 Paola Romagnani, Giuseppe Remuzzi, Richard Glassock, Adeera Levin, Kitty J. Jager, Marcello Tonelli, Ziad Massy, Christoph Wanner, Hans-Joachim Anders
Chronic kidney disease
published pages: 17088, ISSN: 2056-676X, DOI: 10.1038/nrdp.2017.88
Nature Reviews Disease Primers 3 2020-01-24
2016 Tomás P. Griffin, William Patrick Martin, Nahidul Islam, Timothy O’Brien, Matthew D. Griffin
The Promise of Mesenchymal Stem Cell Therapy for Diabetic Kidney Disease
published pages: , ISSN: 1534-4827, DOI: 10.1007/s11892-016-0734-6
Current Diabetes Reports 16/5 2020-01-24
2017 Paul Lohan, Oliver Treacy, Matthew D. Griffin, Thomas Ritter, Aideen E. Ryan
Anti-Donor Immune Responses Elicited by Allogeneic Mesenchymal Stem Cells and Their Extracellular Vesicles: Are We Still Learning?
published pages: , ISSN: 1664-3224, DOI: 10.3389/fimmu.2017.01626
Frontiers in Immunology 8 2020-01-24

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