The patient, who was transplanted in November 2006, has finished the 12-month period of immunosuppression and follow-up, and undergone the last of the tests and observations required by the trial protocol. As planned, the patient has subsequently been enrolled in a separate long-term follow-up study, designed to monitor the patients over a four-year period.
The trial is designed to evaluate the safety and preliminary efficacy of HuCNS-SC (purified human neural stem cells) product candidate as a treatment for infantile and late infantile neuronal ceroid lipofuscinosis (NCL), a fatal neurodegenerative disease also known as Batten disease. To date, five patients out of a planned total of six have been transplanted with HuCNS-SC cells. The company anticipates that the sixth patient will be transplanted in January 2008.
Stephen Huhn, vice president and head of the neural program of StemCells, said: “We consider the completion of the trial by the first patient to be a major milestone.”