REDDSTAR project

The REDDSTAR Project will comprehensively examine if SSC can safely control glycaemia and alleviate damage caused by six diabetic complications namely retinopathy, nephropathy, cardiomyopathy, neuropathy, impaired bone repair, and wound ulceration. REDDSTAR partner Orbsen Therapeutics has identified a novel antibody that binds the surface proteoglycan Syndecan-2 (known as CD362) that can be used to prospectively isolate CD362+ SSC from human bone marrow with enhanced purity ratios. REDDSTAR is split into two phases spread over three years. Phase 1 of the project involves investigation of the safety and efficacy of novel CD362+ SSC, CD362- SSC, and PA-SSC. It also investigates their ability to simultaneously control hyperglycaemia and ameliorate diabetic complications. The second 18 months of the project will involve examining the mechanism of action of how SSC improve 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 that yields the best results in phase 1 of the project. REDDSTAR partner Owl Biomedical are also developing the world’s first bench-top GMP-compliant cell sorter - the MACSQuant Tyto to produce CD362+ SSC for human clinical safety trials that will meet future therapeutic regulatory requirements Update on status: We are currently just past the half way point in this project. The central objective during the initial 18 months of REDDSTAR has been to assess the effect of SSC therapy in each of six preclinical models of diabetic complications. This included the collection and delivery of samples and analyses of three types of SSC: PA-SSC, CD362+ or CD362- SSC. This phase also included development of procedures for isolation and production of CD362+ and CD362- SSC from human bone marrow using the MACSQuant Tyto. Positive effects on blood glucose, kidney disease, neuropathy and wound healing have been demonstrated and studies in other diabetic complications are ongoing. An independent panel at the Steno Diabetes Center in Copenhagen selected Treatment of Diabetic Ulcers with CD362+ SSC for progression to a Phase 1b clinical study in Copenhagen. The next 18 months of the project will involve examining how SSC improve diabetic complications through mechanism of action studies. REDDSTAR partners are also in the process of preparing a clinical trial application to the DKMA to undertake a phase 1b clinical trial on diabetic patients with diabetic ulcers. The project has generated exciting and novel data and technology that has reach far beyond the life of the project and has the potential to impact on many other disease conditions. Collaboration: The REDDSTAR consortium is a network of diabetes specialists working together with regenerative medicine researchers, biotech industrialists and clinicians to develop, validate and translate new breakthroughs in the treatment of diabetes and its associated complications using stem cell therapy. The broad scope of the REDDSTAR project requires unprecedented collaboration between specialists in diverse areas in centres in Ireland, U.K, Germany, Portugal, Denmark, The Netherlands, and the US. Common standard operating procedures, data collection and storage mechanisms are enabling valuable comparisons and correlations between samples and results. The consortium has been assembled with the longer-term aim of establishing a durable collaborative scientific network across Europe and the US.