If successful, the effort could help move the pharmaceutical industry to new methods for early screening of experimental therapies.
The U.S. Food and Drug Administration has awarded a $5.6 million grant to Harvard University’s Wyss Institute for Biologically Inspired Engineering to use its Organs-on-Chips, microfluidic devices lined with living human cells.
The Institute says the chips represent a promising alternative to drug testing in animals. The FDA grant will allow the institute to explore use of the chips to test the safety and efficacy of medical treatments for radiation sickness. The effort will also be supported by a team in the Vascular Biology Program at Boston Children's Hospital.
The multiyear project will investigate if the tiny microfluidic devices, about the size of a computer memory stick and able to mimic complex organ physiology, can be used instead of animals to evaluate potential therapeutics. The project is part of the FDA’s Medical Countermeasures Initiative launched in 2010.
If successful, the effort could help move the pharmaceutical industry to new methods for early screening of experimental therapies. While the institute notes that there are ethical issues surrounding the use of animals to conduct drug testing, they also note that animal models often fail to accurately predict human responses. In the case of tests relating to lethal exposure to radiation, human testing is not feasible.
Acute Radiation Syndrome, or ARS, is a serious illness that occurs when the body receives a high dose of radiation, usually over a short period of time. Symptoms of the potentially fatal syndrome can range from fatigue, fever, nausea, vomiting, and diarrhea, to seizures and coma. The hope is the project will provide a new understanding of how the body responds to a sudden high level radiation exposure that could occur in a terrorist act or a nuclear disaster, such as the Fukushima nuclear accident in Japan in 2011.
“We have a lot to learn about the human physiological response to radiation,” says Luciana Borio, head of the FDA Medical Countermeasures Initiative. She says Wyss’ Organs-on-Chips could help fill knowledge gaps in a safe and cost-effective way.
Three Organs-on-Chips—designed and fabricated using computer microchip manufacturing techniques—will be studied as part of the project. The three devices mimic human bone marrow, gut, and lung organ structure and physiology, organ systems that are most susceptible to the toxic effects of radiation.
August 15, 2013