Narrow Results

SINGAPORE – A New Way of Looking at Cancer

SINGAPORE – Novel Discovery by NUS Scientists Improves Profiling of AML Patients for Targeted Therapies

SINGAPORE – Red Meat Consumption Linked with Increased Risk of Developing Kidney Failure

SINGAPORE – Thomson Medical and UK-based Cell Therapy Limited Collaborate on Stem Cell Research to Develop Regenerative Medicines

UNITED STATES – New Biomaterial Developed for Injectable Neuronal Control

UNITED STATES – Research Shines Light on Lesser Known Form of Vitamin D in Foods

UNITED STATES – MRIGlobal to Lead International Research Collaboration for Tularemia Vaccine

INDIA – Improving Agricultural Yield and Quality through Tissue Culture Technology

TAIWAN – A Cascade of Protein Aggregation Bombards Mitochondria for Neurodegeneration and Apoptosis under WWOX Deficiency

The United Kingdom regulatory landscape as it applies to cell-based therapies is rapidly evolving and constantly produces new information for researchers. This chapter brings together the plethora of information in the form of a process map of the key stages in the life cycle of a cell-based product, from cell/tissue procurement, processing and manufacture, through pre-clinical trials, clinical trials and on to commercialisation and post-launch activities. The critical components of each stage are described, and key issues which are pertinent to the UK researcher are discussed, for example, use of pre-clinical models, documentation requirements for clinical trials. The text goes on to identify which regulations, codes of practice and standards are already available for use in the UK and links them to the life cycle stages. The most recent regulation to be agreed in 2007 in Europe is also discussed. EC 1394/2007 is an amendment of EU Directive 2001/83/EC, and describes overarching regulations of advanced therapy medicinal products (which encompasses cell-based therapeutics).

This information is taken from a Publicly Available Specification (No. 83) which was written by the authors of this chapter and published by the British Standards Institution (BSI) in 2006. It is intended that this PAS acts as a quick reference source to increase clarity for users on the requirements needed for exploitation of a cell-based therapy in the UK, rather than an in-depth examination of the supporting literature.

In spite of the current notable advances in surgical management of critical limb ischemia (CLI), the most severe form of peripheral artery disease, it is still associated with the high frequency of amputations, lethality and low quality of life. Although the compensatory opportunities are mainly exhausted in the treatment of CLI, an efficient medical intervention remains possible. The purpose of this intervention is to eliminate a pronounced imbalance between the blood supply of the ischemic tissues and their metabolic needs. The physiological compensatory arteriogenesis, which actively proceeds at the initial stages of limb ischemia, almost ceases to the beginning of its transition into the final stages. Therefore, research efforts are focused on those technologies for tissue repair which are directed at the activation and expansion of the microvascular bed (angiogenesis) in the affected limb. Cell therapy, having been actively studied from the beginning of 2000s, is one of such approaches. This review discusses in-depth the advantages of different cell types for the CLI therapy, including peripheral bone marrow-derived mononuclear cells (BMMNCs) and mesenchymal stem cells (BMMSCs). The results of the most important pre-clinical and clinical studies, including the ongoing clinical trials, involving cell-based approach for CLI therapy have also been discussed besides optimization of the cell delivery techniques with or without the use of biomaterials as cell carriers.