Orbsen Therapeutics proprietary stromal cell therapy (Cyndacel-M ™) has been selected to be tested in a EU Framework 7 (FP7) funded safety trial for the treatment of non-healing, ulcerating wounds in patients with diabetes. The project known by the acronym “REDDSTAR” (Repair of Diabetic Damage by Stromal Cell Administration) is being co-ordinated by Professor Timothy O’Brien, Dean of Medicine and Director of Ireland’s Regenerative Medicine Institute (REMEDI) at NUI Galway.
Approximately 50 million diabetic EU citizens are using approved anti-diabetic agents to control their diabetes. However, diabetes still leads to 6 progressive complications, namely: nephropathy, retinopathy, cardiomyopathy, neuropathy and wound ulceration. In 2010, 11% of EU adult deaths (634,000) were caused by diabetic complications. The foot ulcer is a leading cause of hospital admissions for people with diabetes in the EU and is a major morbidity associated with diabetes. Diabetic foot ulcers (DFU) are estimated to occur in 15% of all patients with diabetes and precede 84% of all diabetes-related lower-leg amputations.
The clinical study will combine Orbsen’s Cyndacel-M ™ with an existing wound therapy called Excellagen, an FDA-cleared collagen treatment developed by US-based Cardium Therapeutics Inc. (Trading Symbol: CRXM). This transatlantic collaboration between Orsben and Cardium represents an exciting development that brings Cardium’s significant commercial expertise in the wound healing market to the REDDSTAR project.
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