A study at Imperial College, London is examining the use of stem cells to help predict cytokine storms in first human trial participants.
Back in 2006, the papers were full of stories and horrific pictures relating to six men who suffered extreme reactions to the test drug, TGN1412 (CD28-SuperMAB). Four of the men suffered multiple organ failure despite receiving a dose that was around 500-times lower than had proved safe in animal tests.
"As biological therapies become more mainstream, it’s more likely that drugs being tested on humans for the first time will have unexpected and potentially catastrophic effects," believes Professor Jane Mitchell, who led the new research.
Cytokine storm reactions, like those prompted by TGN1412, are tough to predict because they require interactions between blood cells and endothelial cells.
However, because endothelial cells are difficult to access, current testing is usually done using on endothelial cells from one donor and white blood cells from another. The problem is that one donor may have an immune reaction to the other, meaning the body is already primed for inflammation before the drug is added, potentially leading to false test results.
The new test only requires blood from only one donor, making it far more reliable. The researchers are now developing an off-the-shelf kit to enable drug companies to use the test on a large scale.
Pre-market pharmacovigilance will always be a vital component of clinical trials but this test should help remove some of the uncertainty regarding one of the most serious and dramatic of adverse drug reactions.
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