Q-Therapeutics Gains FDA Clearance to Initiate Clinical Trials in ALS

Salt Lake City, Utah-based Q-Therapeutics has obtained FDA clearance of its Investigational New Drug (IND) application to initiate a Phase I/II trials of their proprietary stem cell therapy in ALS patients. The stem cells, called Q-cells, are purified human glial-restricted progenitor cells, which generate two essential cell types for neuronal protection and repair, astrocytes and oligodendrocytes. Preclinical studies have shown that Q-Cells localize to motor neurons in the spinal cord after transplantation and improve survival and motor function in ALS rat models. Q-cells have also been shown to survive longer in the central nervous system than transplanted mesenchymal stem cells. The FDA has already granted Q-Cells orphan drug designation (see April 2014 news), and the Phase I/II study will begin upon securing funding and institutional review board (IRB) approval.

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disease-als stem cells topic-clinical
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