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news.Taxus Cardium Pharmaceuticals has announced that the company's Excellagen flowable dermal matrix in combination with Orbsen Therapeutics' mesenchymal stromal stem cell therapy Cyndacel-M has been selected for clinical evaluation in a Phase Ib safety study for the potential treatment of chronic diabetic wounds to be funded by the EU under EU Framework 7 (FP7).
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The project, known by the acronym "REDDSTAR" (Repair of Diabetic Damage by Stromal Cell Administration), is being coordinated by Dr Timothy O’Brien, Dean of Medicine and Director of Ireland’s Regenerative Medicine Institute (REMEDI) at National University of Ireland Galway (NUI).
In the initial phase of the project, academic and clinical research teams in Galway, Berlin, Belfast, Munich and Porto tested Orbsen Therapeutics’ stem cell product (called Cyndacel-M) against the current standard cell therapy.
An independent panel at the Steno Diabetes Centre in Copenhagen decided to use Cyndacel-M for a clinical study in patients with chronic diabetic ulcers, in preference to the current cell technology. The Cyndacel-M stem cell product candidate consists of a population of highly characterized stromal cells and is designed to provide improved clinical safety and efficacy compared to other cell-based therapies.
Taxus Cardium’s Excellagen product, which has been cleared by the FDA for the treatment of chronic non-healing dermal wounds, has previously been shown to be capable of stimulating the rapid regeneration of granulation tissue, and to provide a matrix capable of supporting the viability of cells and other biologics.
The REDDSTAR preclinical studies therefore evaluated the use of Taxus Cardium’s Excellagen and an alternative collagen-based product to promote the maintenance of stem cell viability. The combination of Cyndacel-M and Excellagen improved wound closure and neo-vascularization in a diabetic dermal wound healing model. Based on those results, Excellagen was selected to be used with Cyndacel-M in the human clinical study.
Taxus Cardium CEO Christopher Reinhard noted that in addition to Excellagen’s FDA-cleared uses for the treatment of chronic non-healing dermal wounds, its pharmaceutically formulated flowable dermal matrix has been engineered as a platform technology, enabling multiple therapeutic product extensions for tissue regeneration based on stem cells, biologics, peptides and small molecule drugs.
"We are pleased to have Excellagen® be selected for this stem cell based clinical study, and believe it could potentially be used to enable and enhance the effectiveness of a variety of stem cell and other clinical applications," Reinhard added.