The project aims to improve the treatments available for diabetic patients, to enhance their health and quality of life. Ultimately it is hoped that such improvements would lead to a reduction in public health costs associated with diabetes and related complications.
Aim and purpose
Millions of patients with diabetes mellitus in the EU are using prescription drugs to control their blood glucose levels. Poor control of blood glucose levels leads to a number of diabetic complications, including: nephropathy, retinopathy, cardiomyopathy, neuropathy, impaired bone repair and wound ulceration. At present, there are few therapeutic options available to control initiation and progression of diabetic complications and they continue to present challenging disease management issues for clinicians. The REDDSTAR Project will comprehensively examine if Stromal Stem Cells can safely control glycaemia and alleviate damage caused by six diabetic complications.
Stromal Stem Cells (SSC) are a mixed population of plastic-adherent (PA) cells isolated from adult bone marrow. PA-SSC secrete potent proteins that impact the immune responses and stimulate the growth of new blood vessels.
REDDSTAR partners have identified an antibody (CD362) that prospectively isolates CD362+ SSC from human, rat, mouse and rabbit marrow, enabling testing of pure CD362+ and CD362- SSC and mixed PA-SSC from each species for the first time.
REDDSTAR partners have collectively developed in vivo models of six important diabetic complications. The project will assess if CD362+, CD362- and PA-SSC exert differing levels of control of blood glucose and tissue repair in each model of diabetes. In addition, the project will determine how CD362+ and CD362- SSC simultaneously repair tissue damage and maintain blood glucose control, an effect not observed with any current therapy. The model with the most promising results will be selected for progression to a Phase Ib clinical study.
REDDSTAR will involve a number of phases, spread over 3 years. The first 18 months of the project will involve investigating the safety and efficiency of SSC in resolving 6 complications arising from diabetes. The impact of SSC upon blood glucose levels will also be tested. This phase of the project will also see the development of appropriate procedures for the isolation and production of CD362+ and CD362- SSC from human bone marrow using owl biomedical’s advanced nanosorting technology.
The second 18 months of the project will involve examining how SSC improves diabetic complications. REDDSTAR partners will also submit a clinical trial application to the Danish Medicines Agency to undertake clinical trials on diabetic patients with the complication(s) that yield the best results in phase 1 of the project.
This research project targets type 2 diabetic patients with either nephropathy, retinopathy, cardiomyopathy, neuropathy, impaired bone repair or wound ulceration.
Expected ending & outcome
Up to now individual diabetic complications have tended to be focused on in isolation, so potential synergies and knowledge sharing between teams has not realized its full potential. The broad scope of the REDDSTAR project requires unprecedented collaboration between specialists in diverse areas. Common standard operating procedures, data collection and storage mechanisms will enable valuable comparisons and correlations between samples and results.
Our results will generate new knowledge in respect of diabetes and related complications, but the results will also have practical application so that this new knowledge can be applied in a clinical setting. While the results will be obtained in the context of research into diabetes, they will have application for similar conditions which arise from different causes.
REDDSTAR also aims to establish and maintain a virtual research community to encourage a multi-disciplinary approach to diabetes/complications research into the future.
National University of Ireland Galway, Orbsen Therapeutics Limited, University of Porto, Queen’s University Belfast, Charité – Universitätsmedizin Berlin, Ludwig-Maximilians-Universität München , Pintail Limited, Owl biomedical, Steno Diabetes Center, Leiden University Medical Center.