Yes, trial participants that benefited the most in terms of reduced MACE outcomes (and disease progression) were patients with high inflammation (high CRP - our cells have potent anti-inflammatory effect) and patients earlier on in the disease process (i.e. Class II - proposed because these patients have more viable myocardium to protect - more to work with so to say). Dr Perin stated the confirmatory trial (let's hope for a phase IV ) will be similar but try to improve outcomes further. So I would imagine treatment group in confirmatory trial will be Class II patients with higher inflammation (and maybe also further filter by including diabetes and/or ischemia as an additional criteria?). The other option to increase the patient population group would be to also include Class III patient with high inflammation but also MUST have diabetes and/or ischemia). In other words, a must to exclude participants without high inflammation (no matter the class), potentially exclude Class III (or if include Class III they must also have further complications of ischemia and/or diabetes). If I had to have a guess they will exclude Class III because of the overall finding that it is better to intervene earlier in the disease process. Looking further down the track may then apply for a label extension to include Class III patients with high inflammation and diabetes and/or ischemia. Will be interesting, should know more soon.
The reason IMO inflamed patients responded best in terms of reduces MACE outcomes is because inflammation may promote the growth of plaque in the arteries and also loosen plaque in the arteries and cause blood clots. So it makes sense that these patients improved the most in terms of reduced MACE outcomes because it is widely accepted MSCs have a potent anti-inflammatory effect (in our case targeting the large arteries in the heart i.e. reduce heart attacks; and also homing to large arteries outside the heart i.e. reduce strokes).
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