| StemCells commented on the PLoS Medicine article published online February 17, 2009 describing a patient who developed “brain tumors” after undergoing repeated transplants of “fetal neural stem cells” in Russia starting in 2001. StemCells stated that, after careful review of the information available, the particular circumstances of this unfortunate case are neither comparable nor relevant to the ongoing clinical development of HuCNS-SC cells, the Company's proprietary human central nervous system stem cell product candidate. Based on the article and references cited therein, StemCells understands that the transplants in the case comprised an uncharacterized and poorly defined mixture of cells from multiple donors. It is unclear what preclinical safety testing was done, if any, on these cells. In contrast, the Company's HuCNS-SC cells comprise a highly purified, well characterized, neural stem cell product that has undergone rigorous preclinical safety testing, including testing for tumorigenic potential. To date, there has been no evidence of abnormal cell growth in several thousand test animals. In addition, the HuCNS-SC cells entered a Phase I clinical trial in 2006 under an IND authorized by the FDA and StemCells has been able to compile and analyze over two years of extensive human safety data. There has been no evidence of abnormal cell growth in any of the patients in this recently completed clinical trial, the transplantations have been well-tolerated and there have been no significant safety or toxicity concerns. In December 2008, the Company received authorization from the FDA to initiate a Phase I clinical trial in a second indication. :t |
