In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.
Cultured limbal and oral epithelial cells have been successfully used to treat patients with limbal stem cell deficiency (LSCD). The most common culture method for these cell therapies utilises amniotic membrane as a cell support and/ or murine 3T3s as feeder fibroblasts. The aim of this study was to refine the production of autologous oral mucosal cell therapy for the treatment of LSCD. Real Architecture for 3D Tissue (RAFT) was used as an alternative cell culture support. In addition, oral mucosal cells (epithelial and fibroblast) were used as autologous alternatives to donor human limbal epithelial cells (HLE) and murine 3T3s. The following tissue equivalents were produced and characterised: firstly, for patients with bilateral LSCD, an oral mucosal tissue
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