www.fdanews.com/articles/101723-first-patient-completes-stemcells-rsquo-batten-disease-trial
First Patient Completes StemCells’ Batten Disease Trial
December 3, 2007
The first Batten disease patient has finished treatment in StemCells’ Phase I trial investigating HuCNS-SC in children.
The trial is evaluating the safety and preliminary efficacy of the purified human neural stem cell product as a treatment for infantile and late infantile Batten disease, a fatal neurodegenerative disorder.
The patient has finished the 12-month immunosuppression period and has been enrolled in a separate study designed to monitor patients over a four-year period.
Five of the six patients have been transplanted with HuCNS-SC cells, and a data safety monitoring committee has identified no safety issues.
StemCells said it anticipates that the sixth patient will be transplanted in January 2008.