A study by NEPHSTROM researchers at NUI Galway was recently published in the journal Internal Medicine| Hormone and Metabolic Research. The open access publication entitled “Effect of Sodium Glucose Co-Transporter-2 Inhibition on the Aldosterone/Renin Ratio in Type 2 Diabetes Mellitus” was prepared by TP Griffin, MN Islam, L Blake, M Bell, MD Griffin, and PM O’Shea. Congratulations to the team!
NEPHSTROM-supported research by partners at Queen’s University Belfast and Belfast Health and Social Care Trust has been identified as a semi-finalist for a Research Poster Presentation Award at ISPOR 2019 in New Orleans, USA. The research poster entitled “PUK21: RACIAL DISPARITIES IN RECORDING ANEMIA AS A COMPLICATION AMONG END-STAGE RENAL DISEASE PATIENTS” will be presented by Nga T.Q. Nguyen on 21 May 2019 at the conference. Nga is a PhD student at Queen’s University Belfast and is supervised by NEPHSTROM PIs Ciaran O’ Neill, Peter Maxwell and Michael Donnelly. At this conference, only the top 10% of accepted research abstracts, based on peer review scoring, are eligible for a research poster award. Congratulations, Nga!
ISPOR is the Professional Society for Health Economics and Outcomes Research founded in 1995 by a small group of dedicated volunteers and visionaries with the goal of serving as a catalyst for advancing the science and practice of health economics and outcomes research worldwide. ISPOR 2019 runs from May 18-22, 2019.
Our partners at the Centre for Cell Manufacturing Ireland (CCMI) based at the National University of Ireland Galway have organized a workshop series: “Selection, Validation and Implementation of Rapid Microbiological Methods for ATMPs“. This event will take place in Galway, Ireland on the 12th and 13th of June 2019.
For more information, download the flyer here.
The NEPHSTROM project team recently had another very successful and productive plenary meeting in Birmingham U.K. hosted by NEPHSTROM partner UHBFT. The meeting began with a warm welcome by NEPHSTROM Coordinator Prof Tim O’Brien, NUIG and a roundtable of introductions for any new attendees. In attendance, there were 23 delegates representing NEPHSTROM partner sites. Scientific Programme Manager Dr Grace Davey, NUIG refreshed the team by presenting the project plan and current timelines. Mark Sweetnam from partner Pintail Limited reported on administrative and project management updates including a review of deliverable and milestones and reporting requirements.
After a clinical production update from the GMP manufacturing sites, NEPHSTROM trial sponsor IRFMN updated the group on the latest status of the NEPHSTROM clinical trial. The timelines and plans for the next six months were presented and discussed in detail. Each clinical partner reported on patient recruitment numbers and future plans to do so including additional means to enhance recruitment. At this time the project is in the very exciting phase of patient enrolment and infusion and each site (Italy, U.K. and Ireland) are actively proceeding with administration of the blinded product (NEPHSTROM ORBCEL-M or placebo) to enroled patients. After lunch, QUB provided the team with a summary of what has been accomplished in the last six months and future plans in terms of the health economics aspects of NEPHSTROM. The meeting also included a review of recent dissemination and communication tasks and success stories that have been captured in the media including press releases re the trial and scientific presentations of NEPHSTROM at UK Kidney Week and the American Society of Nephrology meeting in San Diego, USA. The meeting concluded with a round-up of project tasks, publication plans and post-meeting actions.
Journalists from the European Commission have recently reported on NEPHSTROM in order to showcase the project on the CORDIS website. CORDIS is the Community Research and Development Information Service. It is the European Commission’s primary public repository and portal to disseminate information on all EU-funded research projects and their results in the broadest sense.
In addition, find the NEPHSTROM factsheet and public reports on the CORDIS website here.
NEPHSTROM Scientific Project Manager Dr Grace Davey amongst many other NUI Galway researchers participated at the Galway Science and Technology Festival Exhibition Day on Sunday, 25 November 2018. The interactive NEPHSTROM display in the Bailey Allen Hall of the National University of Ireland Galway exhibited models and props which helped to explain diabetes and its complications and future plans for cell therapy to a general audience. A set of stir tank bioreactors was on display to illustrate the technology required to produce large batches of human bone marrow-derived mesenchymal stromal cells (MSCs) for use as a cell therapy.
Pictured above Dr Grace Davey, NUI Galway
NEPHSTROM PIs Matthew Griffin of the National University of Ireland, Galway and Norberto Perico of the Istituto di Ricerche Farmacologiche Mario Negri (IRFMN) were involved in presentations at the American Society of Nephrology Kidney Week, San Diego, USA. The meeting which ran from the 23-28 October 2018 is the largest international conference for Nephrology.
Norberto Perico, MD gave an invited talk on “Mesenchymal Stem Cell Therapies in DKD: The NEPHSTROM Experience” on October 27, 2018, as part of a session entitled “Diabetic Kidney Disease: New Tricks for Old Targets”. Prof Matthew Griffin was a moderator of the aforementioned session.
Kidney Week provided participants exciting and challenging opportunities to exchange knowledge, learn the latest scientific and medical advances, and listen to engaging and provocative discussions with leading experts in the field.
Prof. Griffin noted: “Diabetic kidney disease was a very hot topic at this year’s Kidney Week. It is clear that the Nephrology community is highly motivated to bring novel and personalised therapies into the clinical arena and to better understand their mechanisms of action in human subjects. Dr. Perico’s presentation was part of a well-attended session dedicated to novel therapeutic targets in DKD and stimulated insightful questions and discussion from audience members about the safety, efficacy and immunological effects of systemic mesenchymal stromal cell administration in people with CKD due to diabetes. The ongoing NEPHSTROM clinical trial is specifically designed to address such key questions”.
“We are pleased the NEPHSTROM clinical trial has commenced and that randomized diabetic patients with kidney disease whose previous therapies failed now are receiving ORBCEL-M™ immunotherapy,” said Dr Larry Couture, CEO of Orbsen Therapeutics. “The study may be a breakthrough moment for patients with end-stage renal disease caused by diabetes.”
Orbsen Therapeutics, a biotechnology company focused on the discovery, development and commercialization of first-in-class stromal cell immunotherapies, announced that ORBCEL-M™, a second generation stromal cell immunotherapy, currently is being administered to patients with type 2 diabetes and progressive diabetic kidney disease in a four-site, pan-European Phase I/II clinical trial.
Orbsen’s patented allogeneic ORBCEL-M yields nearly 100 percent pure stromal cells, a significant increase in purity when compared to first generation stromal cell therapies. The NEPHSTROM study aims to prove whether the purer stromal cells in ORBCEL-M will be more effective in the prevention and treatment of diabetic kidney disease. Up to 40 percent of people with diabetes will develop kidney disease. Many will require a kidney transplant or a lifetime of dialysis.
“It’s a privilege to have the first patients enrolled and receiving treatment at the Mario Negri Institute,” said Professor Giuseppe Remuzzi of the Mario Negri Institute in Bergamo, Italy, and the clinical trial’s lead investigator. “The complementary skills and expertise of the four participating European centers provide a critical network demonstrating the clinical feasibility of this innovative therapy and the opportunity for additional coordinated trials in diabetic patients with progressive kidney disease for whom new therapies are urgently needed.”
Professor Timothy O’Brien, founding Director at Orbsen Therapeutics and coordinator of the NEPHSTROM study noted, “In my clinical practice, I see hundreds of patients with diabetic kidney disease who face the unpleasant possibility of dialysis or kidney transplantation. The outcome of this clinical trial may give patients another alternative and new hope.”
ORBCEL-M performed well in pre-clinical models as a therapy for diabetic kidney disease demonstrating significant improvements in kidney function.
“Encouraged by the promising results of the pre-clinical models, we are optimistic taking ORBCEL-M to the next stage to further investigate the immunotherapy as a solution to slow or stop progressive diabetic kidney disease,” said Steve Elliman, Chief Scientific Officer at Orbsen Therapeutics. “On behalf of Orbsen, we are privileged to be engaged with some of the European Union’s leading researchers and institutions through NEPHSTROM.”
NEPHSTROM’s four primary research locations are:
- The Mario Negri Institute, Bergamo, Italy
- National University of Ireland, Galway, Galway, Ireland
- University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
- Belfast Health and Social Care Trust, Belfast, Northern Ireland
Read the press release here.
NEPHSTROM partners from NUI Galway, Orbsen Therapeutics, Leiden University Medical Center, Terumo BCT Europe NV and the NHS Blood and Transport will facilitate sessions at the Center for Cell Manufacturing Ireland’s event “GMP Manufacturing, Scale-Up and Challenges of ATMPs”. This 2-day event will take place on November 14 and 15, 2018 at the National University of Ireland Galway.
For more information and to register, please click here.
A new NEPHSTROM study has just been published in the Clinical Chemistry and Laboratory Medicine (CCLM): “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)” by Siobhan M. Hamon, Tomás P. Griffin, Md Nahidul Islam, Deirdre Wall, Matthew D. Griffin, and Paula M. O’Shea.
Background: Growth differentiation factor-15 (GDF-15), a stress-responsive cytokine, is a promising biomarker of renal functional decline in diabetic kidney disease (DKD). This study aimed primarily to establish normative data and secondarily to evaluate the potential utility of GDF-15 in DKD using Roche Diagnostics electrochemiluminescence immunoassay (ECLIA) in an Irish Caucasian population.
Methods: Following informed consent, 188 healthy volunteers and 128 participants with diabetes (72 with and 56 without DKD) were recruited to a cross-sectional study. Baseline demographics, anthropometric measurements and laboratory measurements were recorded. Blood for GDF-15 measurement was collected into plain specimen tubes kept at room temperature and processed (centrifugation, separation of serum, freezing at −80 °C) within 1 h of phlebotomy pending batch analyses. Reference intervals were determined using the 2.5th and 97.5th percentiles for serum GDF-15 concentration.
Conclusions: The reference interval for serum GDF-15 in a healthy Irish Caucasian population using Roche Diagnostics ECLIA was established and a preliminary determination of the potential of GDF-15 as a screening test for DKD was made. Further prospective validation with a larger DKD cohort will be required before the cutoff presented here is recommended for clinical use.
Published Online: September 15, 2018 | DOI: https://doi.org/10.1515/cclm-2018-0534
Read the entire NEPHSTROM Publications list here: http://nephstrom.eu/nephstrom-publications/
- Contract/Grant agreement number
- EC contribution
- Starting date
1 May 2015
- NEPHSTROM study published in Kidney360 journal 28th January 2021
- Drs Martino Introna and Josée Golay publish NEPHSTROM research in Frontiers in Immunology 11th December 2020
- NUI Galway’s Prof Matt Griffin presents NEPHSTROM to an array of international audiences 27th October 2020
- NEPHSTROM presented at RenalToolBox ITN Workshop, Galway 21st October 2020
- NEPHSTROM Galway trial team adapts to new patient safety needs 17th June 2020
- National University of Ireland, Galway
- Academisch Ziekenhuis Leiden – Leids Universitair Medisch Centrum
- Orbsen Therapeutics
- Ludwig-Maximilians-Universitaet Muenchen
- Istituto di Ricerche Farmacologiche Mario Negri
- NHS Blood and Transplant
- University Hospital Birmingham NHS Foundation Trust
- The Belfast Health and Social Care Trust
- Pintail Ltd
- Terumo BCT Europe N.V.
- Azienda Ospedaliera Papa Giovanni XXIII Bergamo
- Queen’s University Belfast