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StemCells gets OK to begin phase I trial for Batten disease treatment
By E. Janene Geiss
Philadelphia, Oct. 20 - StemCells, Inc. announced Thursday that it received clearance from the U.S. Food and Drug Administration to begin a phase I safety and preliminary efficacy trial of the company's proprietary human neural stem cell product HuCNS-SC to treat Batten disease.
In a company news release, officials said this is the first-ever FDA-approved clinical trial to use a purified composition of human neural stem cells as a potential therapeutic agent in humans.
"It is truly gratifying that the FDA is permitting this clinical trial to go forward," Martin McGlynn, president and chief executive officer of StemCells, Inc., said in the release.
"This development is a noteworthy milestone not only for our company, but also for the entire field of stem cell therapeutics. Most importantly, it offers hope to the children and families afflicted by this disease for which there is now no cure."
Batten disease is a rare, fatal genetic disorder that affects the central nervous system of children, who suffer seizures, progressive loss of motor skills and mental capacity, eventually becoming blind, bedridden and unable to communicate. Today the disease is always fatal, officials said.
The proposed phase I trial is designed to evaluate the safety and preliminary efficacy of HuCNS-SC for the treatment of infantile and late-infantile neuronal ceroid lipofuscinosis, the severe forms of a group of disorders commonly referred to as Batten disease.
The trial will provide initial data on the treatment's ability to affect progression of the disease, officials said.
StemCells, Inc. is a Palo Alto, Calif.-based development stage biotechnology company focused on stem cell-based therapies to treat diseases of the nervous system.
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