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Stem Cells files IND with FDA for transplanting human neural brain stem cells.

StemCells, Inc., Palo Alto, CA, announced it has filed its first Investigational New Drug (IND) application to the FDA for approval to begin its first clinical investigation of its human neural stem cells (HuCNS-SC-StemCells proprietary neural cell therapy product) in the treatment of Batten disease.

Batten disease is a rare, fatal genetic disorder that affects the central nervous system of children. If approved, the company says it will be the first-ever FDA-approved clinical trial to use a purified composition of human neural stem cells as the potential therapeutic agent.

StemCells says if it receives FDA approval, the study will be conducted at Lucile Packard Children's Hospital/Stanford University Medical Center. The proposed Phase I trial is designed to investigate the safety of HuCNS-SC in the treatment of infantile and late-infantile neuronal ceroid lipofuscinosis (NCL), the most severe forms of a group of disorders commonly referred to as Batten disease. The primary objective will be to measure the safety of HuCNS-SC and evaluate HuCNS-SC's ability to affect the progression of the disease.

Contact: Judi Lum - (615) 475-3100, Web site:
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Title Annotation:nvestigational New Drug
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Jan 15, 2005
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