Stem cell therapy is emerging as a potentially revolutionary new way to treat disease and injury, with wide-ranging medical benefits. It aims to repair damaged and diseased body-parts with healthy new cells provided by stem cell transplants.
Bone-marrow transplants used to treat leukaemia patients are a current form of stem cell therapy. The replacement bone marrow contains blood stem cells, which make new, cancer-free, blood cells.
"Completion of cell banking represents a milestone for our ReN001 stem cell therapy for stroke. We have now shown that our proprietary c-mycERTAM technology has the ability to scale up human stem cells into a well-characterised, consistent and stable product for wide-scale clinical use," said Michael Hunt, Chief Executive Officer of ReNeuron.
The banking and testing process took place at a contract manufacturer in the UK and the Master and Working cell banks have been manufactured to full Good Manufacturing Practice (GMP) standard, having been tested for purity, sterility and stability.
"We believe that this, together with our recently announced repeat pre-clinical efficacy data in stroke, places ReNeuron in a unique competitive position with respect to its ReN001 programme."
ReNeuron has used its c-mycERTAM technology to generate genetically stable neural stem cell lines.
The platform has multi-national patent protection and is regulated by means of a chemically induced safety switch. Cell growth can therefore be completely arrested prior to in vivo implantation.
ReN001 is currently in late pre-clinical development. Subject to successful completion of pre-clinical testing, the Company plans to file for approval to commence initial clinical trials in stroke later this year, with trials commencing as soon as possible thereafter.
The Company has also generated pre-clinical efficacy data with its ReN005 stem cell therapy for Huntington's disease, a rare, genetic and fatal neurodegenerative disorder that affects around 1 in 100,000 people. This programme is in pre-clinical development.
In addition to its stroke and Huntington's disease programmes, ReNeuron is developing stem cell therapies for Parkinson's disease, Type 1 diabetes and diseases of the retina.