StemCells, Inc. has filed with the US FDA an amendment to its initial IND (Investigational New Drug) application to begin a clinical trial of its human neural stem cells (HuCNS-SC) as a treatment for Batten disease. The proposed Phase I trial has been on hold since February 2005, pending a complete response to questions and concerns presented to the company by the FDA. Batten disease is a rare and fatal neurodegenerative genetic condition affecting infants and children.
StemCells announced the filing of its first IND application on January 4, 2005. 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, stated a release here.
Martin McGlynn, President and CEO of StemCells said, "Our primary focus has been the preparation of what we believe to be a complete response letter, in the form of an IND amendment, in an effort to provide the information required so that our application can be taken off of clinical hold. The Company has worked cooperatively with the FDA throughout, with a commitment to resolve all outstanding issues both thoroughly and expeditiously."