Stem Cell Research in California: The Game Is On

California Institute for Regenerative Medicine (CIRM), San Francisco, CA 94107, USA.
Cell (Impact Factor: 32.24). 03/2008; 132(4):522-4. DOI: 10.1016/j.cell.2008.02.014
Source: PubMed


The California Initiative embodied in Proposition 71 was designed to boost embryonic stem cell research and its translation into cell therapies in the face of federal restrictions on such research. With funding starting to flow, the stem cell revolution is now underway.

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    ABSTRACT: Human embryonic stem cells (hESC) are now routinely cultured in many laboratories, and differentiation protocols are available to generate a large variety of cell types. In an ongoing ethical debate opinions of different groups are based on varying sets of religious, historical, cultural and scientific arguments as well as on widely differing levels of general information. We here give an overview of the biological background for non-specialists, and address all is- sues of the current stem cell debate that are of concern in different cultures and states. Thirty-five chapters address embryo definition, potential killing and the beginning of human life, in addition to matters of human dignity, patenting, commercialisation, and potential alternatives for the future, such as induced pluripotent (reprogrammed) stem cells. All arguments are compiled in a synopsis, and compromise solutions, e.g. for the definition of the beginning of personhood and for assigning dignity to embryos, are suggested. Until recently, the major application of hESC was thought to be transplantation of cells derived from hESC for therapeutic use. We discuss here that the most likely immediate uses will rather be in vitro test systems and disease models. Major and minor pharmaceutical companies have entered this field, and the European Union is sponsoring academic research into hESC-based innovative test systems. This development is supported by new testing strategies in Europe and the USA focussing on human cell-based in vitro systems for safety evaluations, and shifting the focus of toxicology away from classical animal experiments towards a more mechanistic understanding.
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    ABSTRACT: U.S. patents directed to stem cell technologies have generated a high degree of interest and controversy. Many patents relating to stem cell technology have faced reexamination, litigation, or both. The U.S. Patent and Trademark Office (USPTO) recently upheld three Wisconsin Alumni Research Foundation (WARF) stem cell patents after reexamination requested by a third-party challenger in 2006. StemCells, Inc., and Neuralstem, Inc., both filed suits with respect to their patents related to neural stem cells. StemCells filed a suit on July 24, 2006, alleging infringement of its patents collectively referred to as "the neural stem cell patents," by Neuralstem, Inc. Neuralstem, Inc., filed a suit against StemCells, Inc., on May 7, 2008, alleging inequitable conduct during prosecution of StemCells' U.S. Patent No. 7,361,505. Both suits are yet to be decided. Pharmastem Therapeutics, Inc., had attempted to enforce its U.S. Patent Nos. 5,192,553 and 5,004,681, which resulted in invalidation of the patents in 2007. It remains to be seen what effect (if any) the recent increases in funding of stem research and the important U.S. Supreme Court decision on KSR v. Teleflex, Inc. (making it more difficult to establish nonobviousness of patentable subject matter) will have on challenges to stem cell patents.
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