For years, people have voiced their concerns over the safety and ethics of clinical trials – especially those where animals and human participants are involved. However, now thanks to a leading group of scientists, researchers may be a step further to solving this issue. Unveiled at the Safety Pharmacology Conference in Washington DC last month, stem cell biotechnology company Novoheart showcased their new ‘mini-heart’ which could remove some of the need for animal and human involvement in trials.
In this month’s blog, Soumac takes a look at how the ground-breaking technology works and its potential implications for science in the future:
How the technology works
Using IPSC technology, scientists take blood cells from patients and embed them into a hydrogel matrix made of collagen. Over the course of a few days, the cells grow and redevelop into heart muscles within the mould, including identical heart ventricles, eventually forming a 3D engineered mini-heart inside the compound.
To monitor and control the heart, scientists use an electric pacemaker that can simulate the heart under different conditions, such as sleep or stress. Sensors are then used to measure things like pressure and volume, allowing researchers to understand how the heart reacts to different situations; which could be particularly beneficial for clinical trials where the effects of drugs on a human heart are not yet clear.
Applying the technology in real life scenarios
As we’ve already mentioned, one of the most promising potential uses for the Novoheart technology is in drug development and trials.
To put things into perspective, currently only 10% of the drugs that enter the first phase of clinical trials – the phase following tests carried out on non-human models – will make it all the way to the market. This makes trials not only time consuming, but also extremely expensive. Novoheart could help researchers detect warning signs sooner rather than later.
What’s more, Novoheart have developed software and analytics to complement the technology, which can be used by cardiologists and scientists to form complex datasets that give them a richer understanding of how drugs affect the mini-heart. Thanks to the use of AI in the software, scientists will be able to understand anything from stroke volume to cardiac output.
There’s also the obvious issue of safety and ethics. While fatalities are rare in clinical studies, the risk is still very real – but if warning signs are detected earlier, this could make the procedure a lot safer – as well as solving some of the limitations surrounding the ethics of using humans in drug trials.
As well as clinical trials, the technology could be applied wider to the development of new drugs and disease modelling.
While the technology is certainly good for delivering short-term results, the long-term effectiveness of the mini-heart is unclear. Stem cells used in Novoheart are usually new and not fully developed – in a normal human heart it can take a couple of decades for the heart to fully mature – meaning the technology may not be the best predictor of a drug’s long term effects on the heart. To back this up, scientists argue that they should be able to speed up the maturing process in a lab; however it’s not yet clear how they plan to do this.
Overall, the technology is certainly a step in the right direction and when compared to its predecessors, the results are definitely more promising. However, it’s highly unlikely that we’ll be able to remove animal and human involvement completely anytime in the near future, meaning for now the Novoheart is merely an aid for clinical trials, but not an overall solution.