ENCAPSULATED CELL TECHNOLOGY

The potential therapeutic applications of encapsulated cells are enorm ous. In the US alone, it has been estimated that nearly half-a-trillio n dollars are spent each year to care for patients who suffer tissue l oss or dysfunction. Over 6 million patients suffer from neurodegenerat ive disorders such as Alzheimer's disease and Parkinson's disease, ove r 14 million patients suffer from diabetes, and millions more from liv er failure, hemophilia, and other diseases caused by the loss of speci fic vital cellular functions. It appears likely that by the end of the decade clinical trials of encapsulated cells to treat many of these d iseases will become a reality. The Food and Drug Administration has al ready authorized studies to evaluate the safety and biological activit y of several types of systems. A number of issues will have to be addr essed, including the sourcing of raw materials, the design and buildin g of manufacturing facilities, the scale-up and optimization process, storage and distribution of the product, and quality control.