StemCells, Inc. announced this morning that it has received approval from the FDA to begin a clinical trial of the Company’s proprietary HuCNS-SC product candidate (purified human neural stem cells) to treat Pelizaeus-Merzbacher Disease (PMD), a fatal brain disorder that primarily affects young children. As of today, there are no approved treatments for this disease.

According to the press release, this is the Company’s second FDA-approved clinical trial to evaluate HuCNS-SC cells as a potential treatment for neurodegenerative diseases. The first study to be approved was the Company’s Phase I clinical trial of HuCNS-SC cells to treat neuronal ceroid lipofuscinoses (NCL), or Batten disease. The Phase I NCL trial is predicted to reach completion next month.

“PMD is one of the most severe myelin disorders known to man. Children afflicted with this disease suffer progressive neurodegeneration and an untimely death. Unfortunately, they have no option for restorative treatment,” stated Stephen Huhn MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc.

He continued, “We are very pleased to be the first company to initiate a neural stem cell trial for a myelination disease. Establishing safety and efficacy of our cells in patients with PMD may pave the way for similar studies in patients with other myelin diseases.”

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