Since our last commentary on the Cell Therapy Catapult clinical trials database, they have released an update expanding to include 34 clinical trials currenty operating in the UK.
This post will give more detail on the commercial companies sponsoring UK clinical trials in cell therapy.
Azellon Cell therapeutics is a spin out company from University of Bristol building on the pioneering work from Professor Anthony Hollander. Professor Hollander was also part of the team involved in the first tissue engineered trachea transplant in Claudia Castillo, as the only stem cell scientist. Azellon have a Phase I/II clinical trial approved for treatment of knee meniscal repair using bone marrow derived mesenchymal stem cells (MSCS) infused onto a biological scaffold.
Reneuron are a publicly limited company, who are the foremost stem cell company in the UK. Their PISCES (Pilot Investigation of Stem Cells in Stroke) is the 'world's first clinical trial of a neural stem cell therapy for disabled stroke patients'. While this is just a safety study, promising initial results application has been made for commencement of a phase II study later this year.
Cell Medica have developed a cytomegalovirus (CMV) specific T cell product, Cytovir CMV, using a proprietary production process, for an immunoprophylatic and pre-emptive treatment of CMV, phase III and II respectively. Another product, Cell Medica have developed is adenovirus specific T cells, Cytovir ADV for paediatric patients post haematopoetic stem cell transplant. Cytomvir CMV is at an advanced stage of clinical trials as is defined as
In the UK, Cytovir CMV is defined as a Cellular Therapy Product that does not fall under the definition of a medicinal product. As such, it is not subject to the licensing process relevant to Advanced Therapy Medicinal Products described in Directive 2001/83/EC and amending Regulations. Neither safety nor efficacy have therefore been established to the level that would be expected for a medicinal product.
Advanced Cell Technology is a US based biotechnology company that, after the well publicised withdrawal of Geron from developing a human embryonic stem cell derived product, are the only company conducting hESC based clinical trials, namely manufacturing a Retinal Pigment Epithelial therapy. In the UK, ACT are currently recruiting for a Phase I/II trial for patients with Stargardt's Macular Dystrophy, in addition to SMD and dry age related macular degeneration (AMD) related I/II trials ongoing in the US.
It is clear from the clinical trials that there is still many hurdles to overcome in order to fulfil their often hyped potential. With big pharma still not viewing cell therapy as a threat to their current business model, they are unwilling to take the risk, leaving smaller biotech companies as the pioneers to negotiate turbulent engineering, regulatory and scientific seas before a new frontier of medicinal therapies can land. It may be a while yet, but these are definitely exciting, albeit tentative, times for the industry.