PROOF OF CONCEPT
Before receiving approval for conducting the clinical trial extensive pre-clinical Proof of Concept (PoC) studies were performed by our team at the University of Zurich to demonstrate the safety, feasibility, and efficacy of our therapeutic approach. Early studies evaluated the optimal components of growth medium required to expand the muscle precursor cells in vitro and demonstrated that in vivo injected cells differentiate, form new muscle fibers and connect to existing tissue, while remaining at the site of injection. The later studies focused on efficacy, demonstrating the regenerative potential of our approach in multiple animal models. It was shown that six months after injection of cells into a damaged sphincter muscle, over 80% of the original muscle strength could be achieved. The results of these studies were patented and/or published in multiple peer reviewed, scientific journals.
Promising results from a phase I clinical trial further demonstrate the safety of this therapy in patients.