Old timers here probably remember that Dr. Itescu has been regularly featured in the Vatican Conferences (Pontifical Council for Culture - Unite to Cure). In fact, in August 2014, the Vatican honored SI with the inaugural Key Innovator Award (from the Pontifical Council for Culture). At that time, it was predicted that the first stem cell-based therapy to treat advanced heart failure – known scientifically as “Class IV” failure – could be on the market in six years.That would be in 2020. So here we are in 2020 waiting for the CHF trial results. How prescient! Right on cue!! Here is my post from 2017 highlighting this: https://hotcopper.com.au/threads/prescient.3931628/?post_id=29869529
Well, why am I bringing up the Vatican connection here and now? Please read on and you will understand (this is a rather lengthy post). 1. The latest clinical trials website lists an EAP for MSC for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19). https://clinicaltrials.gov/ct2/show/NCT04456439?term=mesoblast&draw=2&rank=3 That got me thinking about a panel discussion titled "Is Inflammation the Link Between All Disease?" at the Unite to Cure: Fourth International Vatican Conference: Thursday, April 26, 2018. Dr. Itescu was among a panel consisting of: Dr. Sanjay Gupta (the CNN's Chief Medical Correspondent) Dr. Deepak Chopra, MD (Doctor turned Mind-Body Wellness Expert) Dr. Alberto Mantovani (Oncology and Immunolgy) Dr. Frances Lund (Immunilogy) Dr. Peter Libby (Cardiology) Watch this video here:
Here are some important takeaways from that video: a) Dr. Peter Libby at the 09:18 mark says "The Holy Grail of Clinical Trials is all cause mortality". Let's try to digest that comment in terms of the current Phase 3 COVID-19 ARDS trial that Mesoblast is recruiting for. The primary end point of that trial is all-cause mortality up to 30 days post randomization. So Mesoblast's trial is seeking the Holy Grail. No current trial for COVID-19 ARDS can come close to matching that. N-O-N-E.
b) Dr. Itescu's talk starts at 18:00 and finishes at 25:00. It is a presentation on stem cells and the various Mesoblast trials. What follows is a question by Dr. Sanjay Gupta to which Dr. Itescu answers as follows (this is perhaps the best explanation that I have heard of how MSCs work): "These cells are living delivery vehicles of multiple factors that are necessary to reprogram the tissue. So the cells do not engraft. They do not last long. These are not typical stem cells. They are cell delivery vehicles. So you put these cells into an area of inflammation. They are activated by the inflammatory cues and then really have a two-step process. One is a secretion of a number of factors that turn off the inflammation and then a second wave of secretion effectors that result in tissue repairand you need that 2 step process to get tissue recovery. The reprogramming of the endogenous tissue which clearly involves multiple pathways as opposed to single pathways typically targeted by drugs. Multiple pathways is the only way really where we are going to see recovery of these complex diseases where inflammation has disrupted these pathways in the first place". Points to be noted from SI's response are: i) MSCs repair tissue. This is why this is regenerative medicine. So while the rest of the world's treatments are drugs, they cannot repair the lung tissue (or other tissue) like MSCs can. Not CytoDyn. Not Gilead. Not Moderna. Not Johnson & Johnson. Certainly not vaccines. This is why ARDS patients on ventilators will get cured by Remestemcel-L. Their lung tissue will get repaired and regenerated. In another post, I highlighted VILI (Ventilator Induced Lung Injury), once again I mention how Remestemcel-L can not only cure ARDS but also help patients get "new" lung tissue: https://hotcopper.com.au/threads/vili-and-mscs.5339774/?post_id=44012324
ii) The latest EAP for Multisystem Inflammatory Syndrome in Children (MIS-C) associated with COVID-19 is based on MSCs targeting Inflammation. What is remarkable is the choice of Remestemcel-L in the EAP apparently to target multiple organs with MIS-C (hence the name "multisystem"), not just the lungs/lung tissue. Note that MIS-C affects heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. So this latest EAP for MIS-C could well prove to treat all these organs, not just the lungs/lung tissue (as is the case for COVID-19 induced ARDS). Is Remestemcel-L going to repair these other organs? That is the BILLION dollar question.
c) At the 50:00 minute mark, Dr. Sanjay Gupta asks SI about Mesoblast's Chronic Low Back Pain therapy and SI gives a good explanation of how opioids are not an additive treatment for CLBP. At that point, Dr. Peter Libby remarks "He wants to put neurosurgeons out of date". Indeed! SI is looking to do just that, I think.
So in conclusion: 1. MSCs cure diseases caused by inflammation. And inflammation is the link between all diseases. 2. The latest EAP for MIS-C (in children), in my opinion, will be able to cure multiple organs by taming the Cytokine storm. This is a clue that Remestemcel-L can cure not just aGVHD, ARDS but could also cure other organ damage. 3. The challenge is: how to explain this to the world? How do you convince the pharma companies and the general public that Mesoblast has a cure and can actually repair your organs/tissue while drugs are only treating symptoms? I think the key is to get that first FDA approved treatment to the market. Then the rest of the pieces will fall into place, provided pricing is competitive.
PS: I really think that Mesoblast management should have issued an official press release about the latest EAP for MIS-C (instead of finding out about it from anonymous random people on the internet). I believe any other company would have shouted aloud about it from the rooftops.
(20min delay)