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news.StemCells, a biotechnology company, has received approval from the FDA to initiate a clinical trial of the company's HuCNS-SC product candidate to treat Pelizaeus-Merzbacher disease.
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This Phase I trial is designed to evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for Pelizaeus-Merzbacher disease (PMD). Currently, there are no approved treatments for this disease.
This is the company’s second FDA-approved clinical trial to evaluate HuCNS-SC cells as a potential treatment for neurodegenerative diseases. The first such study 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 expected to be completed in January 2009.
The company has begun the process of seeking approval from the Investigational Review Board of potential clinical trial sites in order to begin enrolling patients.
Stephen Huhn, vice president and head of the CNS program at StemCells, said: 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.