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news.California-based biotech firm StemCells Inc has received a manufacturing license for its cell processing facility from the state regulatory agency. This enables the company to use its proprietary neural cell therapy product, HuCNS-SC, which is made at its licensed facility, in clinical trials.
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“Acquiring this license is another milestone in our progress toward beginning our first human clinical trial,” said Martin McGlynn, president and CEO of StemCells. “In addition, the California location of the facility improves our position as a potential recipient of Proposition 71 funds.”
Proposition 71 is an initiative intended to encourage stem cell research in the State of California, and to finance such research with State funds of approximately $295 million annually for 10 years beginning with 2005.
The company previously filed an investigational new drug application with the FDA to begin a clinical trial of its human neural stem cells for the treatment of Batten disease, a rare and fatal neurodegenerative genetic condition affecting infants and children. The initiation of clinical trials for this filing has been delayed by the FDA, but the company is says that it is planning to submit an IND amendment in this quarter.