Product development

Research towards a product

The HE-SUB project (High-Efficient-Single-use-Bioreactor) combines several individual technologies from previous FP6 projects into one product that is capable of producing enough stem cells for one therapeutic treatment per day per unit. The HE-SUB product concept is a Single-Use-Bioreactor, which integrates a porous fibre scaffold (CerCore and CellCore) optimised for the proliferation of mammalian cells and a sensor package that measures a range of key parameters, and which provides cost-efficient production of human stem cells for therapeutic treatment of a range of diseases including heart disease, diabetes, neurodegenerative diseases, musculoskeletal disorders, spinal cord injury, stroke and autoimmune diseases.

The Proof-of-Concept (PoC) of the new bioreactor focuses first on cell therapeutic application to Muscular Dystrophies (MD) including Duchenne Muscular Dystrophy (DMD). For DMD treatment as approach in a previous European project, MYOAMP, injection of adult myoblasts has led to the development of new muscle fibres, but several limitations have been identified, such as poor cell survival and limited migratory ability and limited injectable cell numbers. As an alternative to myoblasts, myogenic stem cells are preferable for therapeutic applications due to their capacity for self-renewal and myogenic differentiation potential.

Approaches in muscular dystrophy treatment are multiple nowadays; stem cell-based replacement therapy is one of these. Other methods targeting at gene level, e.g. adeno-associated virus treatment correcting mal-functioning dystrophin (exon-skipping) for DMD treatment, have become highly promising. Stem cell-based therapy is viewed today as a solution for these patients or as a complementary treatment for instance in the case of insufficient precursor cell pool in the patient. Large-scale stem cell production is a key for therapy today.

HE-SUB was funded by the FrameProgram-7 call HEALTH.2013.0-1 titled “Boosting the translation of health research projects’ results into innovative applications for health”.
The HE-SUB Collaborative Project “High Efficient Single-Use-Bioreactor simulates mammalian tissue conditions for expression and proliferation”. Project period from May 2013 to April 2016 developing products for ProlifeCell designed for stem cell mass production for therapeutic treatments.