Current Collaborative Projects
Orbsen has partnered with 25 independent and global leaders in MSC therapy development, across the EU and North America, for the validation, development and commercialization of ORBCEL™ products in a number of fields, including diabetic, auto-immune and inflammatory conditions. These strategic alliances are funded by €25 million in grants from the European Union Framework 7 (EU FP7) and Horizon 2020 projects.
Orbsen is collaborating with Prof. Tim O’Brien at NUI Galway, Owl Biomedical Inc. (USA), Pintail Ltd, Prof. Willem Fibbe at LUMC; Prof. John Nolan at the Steno Diabetes Centre (DK), Prof. Hans Joachim Anders at LMU, Prof. Alan Stitt at Queens University Belfast, Prof. Carsten Tschope at Charite Hospital in Berlin and Prof. Isaura Tavares at the University of Porto. REDDSTAR is focused delivering ORBCEL-M™ therapy for the microvascular complications of diabetes. REDDSTAR officially started in December 2012 and aims to bring ORBCEL-M™ to a Phase 1b clinical trial in 2016.
The MERLIN project is developing stem cell-based therapies that specifically target the inflammatory components of liver disease. MERLIN brings together a diverse, multidisciplinary panel of experts in liver disease, regenerative medicine, secure data management, biotechnology and clinical trials, and includes BioInVision, Erasmus Medical Centre, the Fondazione Humanitas per la Ricerca, the NHS Blood & Transplant, Orbsen Therapeutics, Pintail Limited, and the University of Birmingham (Coordinator). The team will deploy Orbsen Therapeutics’ unique stromal cell population isolated using patented technologies which deliver purer and better-characterised stromal cells than those used elsewhere. The cells will be deployed in a series of pre-clinical tasks which will elucidate how stromal cells are distributed around the body (bio-distribution), how stromal cells address inflammation, and how the cells’ efficacy and activity change over time using novel biomarkers. The project will carry out a clinical trial using stromal cells to treat patients with a particularly severe inflammatory liver disease – Primary Sclerosing Cholangitis (PSC).
The NEPHSTROM project, funded by Horizon 2020, is a collaboration of 11 European partners and builds on pre-clinical research carried out in REDDSTAR. It will evaluate the clinical safety and efficacy of Orbsen’s next-generation cell therapy for the treatment of Diabetic Kidney Disease. The four-year project will test ORBCEL-M in a four-site clinical trial treating patients in Ireland, Northern Ireland, England and Italy. The cells will be purified from healthy donor bone marrow using Orbsen Therapeutics’ patented technology, and expanded into multiple ‘off-the-shelf’ doses for clinical use. By 2016, first-in-human trials will see the cells injected into patients with diabetic kidney disease. In order to underpin future routine clinical use, NEPHSTROM will develop and validate a new combined manufacturing platform that improves the consistency and reduces the cost of the MSC therapeutic. This will involve the development of the first “closed-automated” GMP method of MSC isolation and expansion, and the creation of a network of four European cell production centers.
BrainMatTrain is an EU-funded Marie Skłodowska-Curie European Training Network (ETN) focussing on a comprehensive understanding of Parkinson’s disease fully supported by 8 partners, including NUI Galway (Coordinator), Medical University of Innsbruck, Lund University, Commissariat à l’Énergie Atomique, Technical University of Denmark, Radboud Medical Centre, Collagen Solutions, NEOS Surgery, and Orbsen Therapeutics. This ETN will educate and train fifteen early stage researchers (ESRs) in functionalised biomaterials, materials science, functionalization strategies, molecular biology, stromal cell biology, in vitro model systems, in vivo neuroimaging, animal models and prototype design. Recruited ESRs will receive compulsory discipline-specific, generic and complementary transferable skills training.
VISICORT (Adverse Immune Responses and their Prevention in Corneal Transplantation) is a five-year EU FP7 project with 12 academic and industry-based partners from France, Germany, Denmark and the UK. The project will design and initiate an optimised clinical trial strategy of the immunomodulatory effects of ORBCEL-C in high-risk corneal transplant recipients. A Phase 1b dose escalation trial of ORBCEL-C as an immunotherapy to prevent the rejection of cornea transplants will commence in early 2017.
The DECIDE Initial Training Network is a three-year program that brings together scientists–such as Prof. Rhodri Ceredig at REMEDI–who have made important advances in the fields of haematopoiesis and differentiation therapy with both scientific and therapeutic targets. DECIDE aims to advance understanding of normal blood cell development and why primitive cells fail to differentiate in cancer. Orbsen will focus on understanding the role of CD362+ stromal cells in haematopoiesis and cancer. DECIDE officially started in early 2013.
REALIST is a Wellcome Trust Health Innovation Challenge Fund (HICF) funded Phase 1/2 clinical trial to assess the safety and efficacy of ORBCEL-C in 75 patients suffering with moderate to severe Acute Respiratory Distress Syndrome (ARDS). The REALIST study will be performed at Queens University of Belfast and led by our collaborators Professors Cecila O’Kane and Danny McAuley at. ARDS causes the lungs to fail due to the collection of fluid in the lungs. There is a large economic burden with direct healthcare costs, but also indirectly due to the impact on the patient through an inability to return to full time employment. There is little evidence for effective drug treatment for ARDS. There is increasing information that allogeneic stromal cells (ASCs) might be important in treating ARDS. REALIST will investigate if a single infusion of ASCs will help in the treatment of ARDS. The first step will be to first of all determine what dose of ASCs is safe and then divide patients suffering from ARDS into two groups, one of which will get ASCs and the other a harmless dummy (or placebo) infusion, who will then be followed up to determine if lung function improves. If effective this may lead to further research to determine if ASCs are effective in patients with ARDS.