Bioengineering

IND filed for human neural stem cell transplant treatment for Batten Disease

Published in Gene Therapy Weekly, February 3rd, 2005

StemCells, Inc. (STEM) announced the filing of its first investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA).

Subject to approval, the company plans to begin its first clinical investigation of its human neural (brain) stem cells (HuCNS-SC, StemCells' proprietary neural cell therapy product) in Batten disease. Batten disease is a rare, fatal genetic disorder that affects the central nervous system of children. If approved by the FDA, this would mark the first-ever FDA-approved clinical trial to use a purified composition of human neural stem cells as the potential therapeutic agent.

On approval of the IND by the...

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Source: Gene Therapy Weekly (2005-02-03)

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