|European Patent Office||Published Application||3024921||06/01/2016||2014-005|
Additional Patent Pending
Current methods to evaluate drug safety and efficacy are costly, inefficient, and rely on nonhuman animal models that fail to mimic the human physiology. The data obtained with animal models therefore cannot necessarily be extrapolated to human subjects. For example, in 2004 the U.S. FDA reported that 92 out of every 100 drugs that successfully passed animal trials subsequently fail human trials. Moreover, out of every 10,000 compounds that go through research and development, approximately 5 to 10 drugs make it to the clinical trials and ultimately only one receives US FDA approval. The average time for this process is about 10 to 15 years and costs around $800 million to $1 billion. What is needed is a human disease-specific in vitro micro-physiological system that re-constitute organ-level functions at the tissue level.
UC Berkeley researchers have developed a microfluidic 3D heart tissue model which uses human induced pluripotent stem (iPS) cell-based myocardium on a chip which simulates cardiac tissue structure and function at a micron level and can provide high-throughput testing of different compounds for therapeutic applications. The cardiac tissue on a chip can be used as a drug screening system and will thus make the drug discovery process more economic, predictable, and efficient.
Functionality of the device has been verified using hiPS cells differentiated into cardiac myocytes (hiPSC-CMs). When seeded, these hiPSC-CMs have shown consistent beat rate over multiple weeks in medium with and without serum.
The model was validated and tested with various physiological agent having known clinical effects. The IC50 or EC50 values were determined and the pharmacological studies on the model showed IC50 or EC50 values that were more consistent with the data on tissue scale references compared to cellular scale studies.
drug screening, drug development, drug discovery, cardiac, tissue model, organoid chip, biochip, stem cell, iPS