PubMed · 13839508
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O A TROWELL, D R WESTGARTH. 1959. A method for differential cell counting in certain organs.. https://doi.org/10.1002/ar.1091340309
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The Food and Drug Administration (FDA) is classifying the Immunomagnetic Circulating Cancer Cell Selection and Enumeration System device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
Vascular endothelial growth factor (VEGF), the most potent angiogenic peptide, protects the neurons against experimental ischemia. However, its neuroprotective effect on human brain is unknown. The present study attempted to determine whether VEGF can protect human cerebral neurons in vitro. A1 human hybrid clonal neurons (human cerebral neuron + neuroblastoma cell) were exposed to hypoxia with glucose deprivation. Pretreatment with VEGF reduced the A1 cell death, and VEGFR-2/Flk-1 and VEGF increased with a neuroprotective effect. However, the human neuroblastoma or neuroglioma cells failed to show these findings. Our results suggest that VEGF can protect human cerebral neurons from cell death after an ischemic insult in vitro, which is correlated to both increased expression of VEGFR-2/Flk-1 and VEGF within the cells.