FDA expands study to analyze differences in sex-specific responses to radiation

MCM regulatory science news

FDA expands study to analyze differences in sex-specific responses to radiation

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

Related links:

• A gut reaction...on a chip - First study of radiation exposure in human gut Organ Chip device offers hope for better radioprotective drugs, from Wyss
• Organs-On-Chips Technology Infographic (PDF, 389 KB) - Information about organs-on-chips research from FDA's Center for Food Safety and Applied Nutrition 
• Radiological and Nuclear Emergency Preparedness Information from FDA