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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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 Outcomes and results

 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.

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

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

 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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