banter and General Discussion, page-9795

I agree with your thought that the gut potentially opens up a whole new field of possibility for products that can influence harmful inflammation. Especially for products that can operate in an environment such as the gut, where countless microbial, chemical and physical influences intersect in ways that we probably never will understand. The gut is a robust environment but also one where an imbalance in one factor can have multiple effects in other processes. A rough analogy might be where the loss of krill in far distant southern oceans could impoverish essential diet for people in the opposite hemisphere via outwardly spreading circles of food chain depletion. We already know that disturbances in the gut biome can harm our brains. The term sh*t for brains is unconsciously perceptive.

A very important consequential point related to these unknowable biological relationships in the gut is that when we come charging in with powerful substances, trying to improve bowel conditions there is a great risk of upsetting some other vital process there. The proven very low toxicity of Mesoblast's stem cells is a winner here.

As to off label use, this is an area where I'm quite lost. I can understand that clinicians who have followed MSB's progress would be keen to try this safe, if unproven, therapy for their patients who are at the end of their tolerance for truly nasty diseases, but I don't know what regulatory hurdles and funding challenges must be overcome. I am certain that there are many researchers and clinicians who are very keen to explore the potential for stem cells in treating currently unmanageable conditions. The FDA holds the starter's gun.