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Rappa

6,264 Posts.

13/02/17

18:07

Post #: 22577525
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Originally posted by The Yankee ↑

Comparing the Aug 09, 2016 Phase 2 RA trial results with today's Ann:
1. The 08/09/2016 trial results were (obviously) in humans but the primary objective of that was to evaluate safety and tolerability of MPC-300-IV.
a) safety was established - meaning no serious adverse affects
b) Tolerability - was well tolerated after intravenous injection of the stem cells
2. The other objective was to measure effectiveness. Which was done by
a) Improvement in ACR 70, ACR 50 and ACR 20 (these are the patients' assessments)
b) Improvements were shown in swollen joint counts, investigator global assessment, patient global assessment, and
patient pain scores.

As we can see, most everything fro the human study was based on improvement in pain and function. There were no objective measurements within the human anatomy/biology itself.

So what about the study on sheep??
Here are the main things to be noted:
a) Its showed objective improvements by way of reduced joint cartilage erosions, and improved synovial inflammation and histopathology
The important thing to note here is that cartilage erosion, synovial inflammation and histopathology were NOT evaluated in the human trial.
b) STRO-1 positive MPCs have been shown to be at least 10- fold more potent inhibitors of T-cell activation and proliferation than conventional plastic-adherent Mesenchymal Stem Cells (MSCs)
c) The study in sheep provides translational and mechanistic support to the trial in humans.

So what the heck does "translational and mechanistic support" mean?
Translational means scientific discoveries are moved along a virtual path from the laboratory into real-world practice, leading to improved human health.
Mecahanistic means that which explains the mechanism of action (in this case, how the stem cells are acting physically to improve the cartilage, synovial fluids, etc.)

My take:
1. Using STRO-1 postive MPCs is 10 times more potent
2. Mesoblast's MPCs for RA is clearly showing measurable improvement in cartilage erosion, synovial inflammation and histopathology - something that wasn't done in the human trial yet
3. The super awesome results in sheep provide support to the human trial in that humans too could show these objective, measurable improvements (though that is something that needs to be demonstrated in humans of course).

Awesome, awesome results!!

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