Evaluation of preclinical studies performed within the REDDSTAR Project

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Evaluation of preclinical studies performed within the REDDSTAR Project: Treatment of Diabetic Ulcers with CD362+SSC (Orbcel-M) recommended for clinical phase 1b study.

On 22nd April 2014, the REDDSTAR consortium gathered in Paris to evaluate the project’s preclinical studies on SSC treatment of diabetic complications.

The central objective during the initial 18 months of the REDDSTAR project had been to assess the effect of SSC therapy in six preclinical models of diabetic complications: diabetic ulcers, diabetic nephropathy, diabetic neuropathy, diabetic cardiomyopathy, diabetic retinopathy, and healing of fractures in diabetes. The studies evaluated SSCs of three types: PA  (plastic adherent), (CD362+) or (CD362-) SSCs.

An advisory board consisting of Professor Jens Kastrup, (Rigshospitalet), Chief Physician Jesper Sonne DSSC (Bispebjerg CEO), Torben Balchen (Dantrials), Professor Peter Rossing (Steno Diabetes Center) and Tanja Thybo (Steno Diabetes Center) was tasked with evaluating the studies with the intention of recommending one study (if possible) for a phase 1 trial.   The advisory board was also asked to recommend which cell type to recommend if a phase 1 trial was possible.

Although all the studies submitted offered promising avenues for further study, the advisory group selected ‘Treatment of Diabetic Ulcers with CD362+SSC” for a clinical phase 1b study.

The initial ‘diabetic ulcer study’ focused on wound healing of punch biopsies in rabbit ears of alloxan diabetic rabbits.  Excellagen (a collagen matrix approved by the FDA) was used as an active control and as a scaffold for cell applications. All three cell types listed above were added to Excellagen for one week and tested.  The endpoints were wound closure (wound tracing) and angiogenesis assessed structurally.  The study found that CD362+SSC delivered the best wound healing outcomes, and also demonstrated significant improvement in angiogenesis.

The advisory board discussed the advantages of this study, noting that:

  • CD362+SSC provided consistent results in a relevant model;
  • dose translation to human would be possible in a topical treatment; and
  • CD362+SSC had provided the best results as was a priori hypothesised.

The advisory board concluded that a phase 1b trial could be done with diabetic ulcers and topical administration of CD362+SSC (trademarked by Orbsen Therapeutics as Orbcel-M), in combination with Excellagen.

The conditions which were not selected to proceed to clinical trial will continue to be investigated, and are the focus of an upcoming Exploitation Workshop.