lunes, 22 de octubre de 2018

Organs-on-chips research update - U.S. Food and Drug Administration

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update

MCM regulatory science news
FDA expands study to analyze differences in sex-specific responses to radiation
Human Organs-on-Chips connect to each other to replicate human body functions. Image of organ-chip, courtesy Wyss Institute.
Organs-on-chips mimic the structure, function, and interactions between living tissues within human organs – such as the lung or intestine – on chips the size of a thumb drive. Scientists can use these chips for drug research, including supporting development of medical countermeasures (MCMs).
Under an FDA contract awarded in 2013 to support development of MCMs to treat acute radiation syndrome (ARS), Harvard University’s Wyss Institute for Biologically Inspired Engineering demonstrated that its bone marrow chip produces human red and white blood cells for up to one month in culture. The chip also faithfully mimics human bone marrow responses to ionizing radiation as well as effects of known chemotherapies and radiation countermeasure drugs.
Because scientific evidence indicates that sex differences may play a major role in how bone marrow responds to radiation, FDA's Office of Women's Health and Medical Countermeasures Initiative (MCMi) have awarded a follow-on study to this project to enable the Wyss team to create male and female human bone marrow chips to analyze differences in sex-specific responses to ionizing radiation and a chemotherapeutic drug.

Image: Human Organs-on-Chips connect to each other to replicate human body functions. Image of organ-chip, courtesy Wyss Institute.

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