As for implementation of our project in the real world, we envision that our project will provide a novel diagnostic and therapeutic approach to fight against IBD. Specifically, our diagnostic tools can help with the early diagnosis of IBD for potential IBD patients, and our engineered probiotics have the potential to become one of the legitimate treatments of IBD and receive accreditation from both doctors and patients if they can succeed in future biosafety evaluations.
Fig.1 Discussion with Yue Li, a doctor major in IBD treatment from PUMCH.
We do realize that although our preliminary results are very encouraging, huge further efforts are needed before our project can be implemented in real world. For diagnosis part, we need to further validate our method using synthesized RNA and then test it with real clinical samples to establish the detection limit and specificity of our method. We envision our diagnostic method can be used with a variety of samples from blood to saliva, but further experiments must be carried out to verify our hypothesis and optimize the sample pretreatment protocols. For probiotic therapy, we need further experiments to support our initial results that those engineered bacteria can indeed inhibit noxious bacteria and restore corroded intestinal mucosa. Also, since the engineered bacteria will be administrated into human body, we do face lots of challenges including biosafety issues and public policy that might hinder our implementation.
While the prospects of implementation are bright, the roads have twists and turns. The genetic stability, risk of escape, and safety on human body of our engineered strain are major issues we need to tackle before our proposed methods can move forward to clinical trials and even be used in real world. At the current stage we have already met all the standards of animal experiments of Tsinghua University and are authorized to try out our probiotics in mice, and up to now all these safety concerns have been solved in our animal model. However, when it comes to human experiments things are destined to become extremely complicated. Since probiotic treatments involve introducing live genetically engineered bacteria into human bodies, we could never be too cautious.
Another concern stems from the public policy--government’s supervision on this field is very tight. Only 22 kinds of probiotic medications were permitted by 2011. Another important thing to be noted is that among those permitted treatments the vast majority of them are natural strains, yet the probiotics in our project are genetically edited, which might introduce unknown variables to the organism, increasing the difficulty of passing the administrative evaluation. So even if we can convincingly show that our method is safe, we might face strong resistance from public policy makers.
Fig.2 Discussion with Junbiao Dai, a scientist expert in yeast artificial chromosome.