21.10.2013 15:24:55
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StemCells Reports Results Of Four-year Observation Study In Batten Disease
(RTTNews) - StemCells Inc. (STEM) reported the results of a four-year observation study in patients with neuronal ceroid lipofuscinosis, also referred to as Batten disease, who had been transplanted with the company's HuCNS-SC cells (purified human neural stem cells) in the initial Phase I study. The company said, key results include long-term evidence of safety, up to five years post transplantation, for the surgical transplantation of the HuCNS-SC cells into multiple sites in the brain and at doses of up to one billion cells.
Six patients were enrolled in the Phase I clinical study in Batten disease. All six were transplanted with HuCNS-SC cells and followed for twelve months after transplantation. Five patients completed the Phase I study and subsequently enrolled in a four-year, long-term observational study, with three of the five surviving to the end of the four-year study. The company said the reported adverse events are consistent with the underlying disease and there have been no safety concerns attributed to the HuCNS-SC cells.
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