Cell therapy clinical trials: Industry

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 therapy clinical trials: Part 1 - Academia

The Cell Therapy catapult recently published a database for the current UK clinical trial in cell therapy (See here).
It details 21 studies and it's quite striking that the majority of these are academia, with only ReNeuron, Cell Medica, ACT and Azellon Cell Therapeutics (Uni. of Bristol spin out) representing commercial companies and only Cell Medica at later stage clinical trials.

This post will concentrate on the great work that is being translated into clinical trials from academia

Cell Type & indications

The majority of these clinical trials are for autologous therapies.

Professor Anthony Mathur, Queen Mary University of London, is leading 3 clinical trials. REGENERATE trials for acute myocardial infarctionchronic heart failure and dilated cardiomyopathy use autologous bone marrow derived mononuclear cells (BM-MNCs) injected either intra-coronary or intramyocardial.
Prof. Mathur is also heading a European wide phase III trial using BM-MNCs for AMI in 3000 patients.  This trial will assess the effect to all cause mortality. With such a large recruitment, although results are not expected until 2017 it will be clear the importance of this therapy for this indication.

Stem Cells in rapidly evolving active multiple sclerosis (STREAMS), led by Dr Paolo Muraro. This use autologous bone marrow derived mesenchymal stem cells that have been cultured for 'up to 52 days'.

The TRANSEURO clinical trial is run by a European consortium to deliver fetal dopaminegeric mid-brain grafts to patient's with Parkinson's Disease.

Professor Nagy Habib, Imperial College London, is used bone marrow (and leukapheresis) derived expanded CD34+ adherent cell population for liver insufficiency, diabetes, and ischemic stroke. These trials have been ongoing since 2007, emphasising the trend of a much prolonged period for completion from academia led trials compared to commercial.

Great Ormond Street Hospital is conducting a phase I trial using gene therapy to produce 'safe' T cells to prevent GvHD . University College London also has a gene therapy T cell product for acute lymphoblastic leukaemia.

Birmingham and Edinburgh University have formed a collaboration conducting phase II trials using autologous CD133+ selected haematopoetic stem cells for liver cirrhosis

Prof. Francisco Figueiredo at Newcastle University is leading Phase II trials for limbal stem cell deficiency using autologous limbal stem cells from the untreated eye. Edinburgh University is targeting a very similar indication in corneal stem cell deficiency using an allogenic source of corneal cells manufactured on an amniotic membrane. The Institute of Opthamology, London, has a very similar product due to go into clinical trials at the end of this year