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FDA approves first human neural stem cell clinical trial to treat brain tumors
Date:6/8/2010

tumor-tropism of neural stem cells to deliver therapeutic agents to invasive tumor sites, which they demonstrated in laboratory testing. The therapy uses a genetically modified human neural stem cell line, generated by Seung U. Kim, M.D., Ph.D., professor in the Division of Neurology at the University of British Columbia, to deliver a prodrug-activating enzyme (cytosine deaminase) to brain tumor sites. This enzyme converts a relatively nontoxic prodrug (5-Fluorocytosine, 5-FC), which is delivered systemically, into an active cancer-fighting chemotherapeutic (5-Fluorouracil, 5-FU). In effect, this stem cell-mediated strategy achieves production of the chemotherapeutic drug only in the area of the tumor. This investigational treatment concentrates anticancer compounds at tumor sites while minimizing exposure of surrounding healthy tissue.

"This novel tumor-selective treatment has the potential to overcome many obstacles that limit the success of currently available treatments for malignant brain tumors and other invasive cancers," said Aboody. "Using neural stem cells as delivery vehicles for therapy may allow us to target concentrated therapeutics specifically to tumor sites while reducing the undesirable side effects of current chemotherapy regimens, including toxicity to normally dividing bone marrow, gastrointestinal tract, skin and hair cells."

The clinical trial will begin accepting patients this summer, with the goal of enrolling 12 to 20 patients with recurrent high-grade gliomas. The modified neural stem cells will be injected during surgery into the wall of the cavity remaining after tumor tissue has been removed. Study patients then receive daily doses of the prodrug 5-FC for one week. Based on Aboody's laboratory findings, once the 5-FC crosses the blood-brain barrier, the neural stem cells will convert the 5-FC to the active chemotherapy agent, 5-FU, at tumor sites in the brain. The phase I safety trial will assess the maximum tolerat
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