I would emphasize that only 70 (44%) of the 159 patients in the LVAD trial were ischemic - and they had great results. The original trial results (in my view) failed to show enough benefit for FDA approval because more than half the trial was non-ischemic and not enough benefit was seen in the non-ischemics, which reduced the overall impact of the benefit in the whole trial to less than the cutoff required by the FDA.End-stage ischemic heart failure patients with LVADs are older and have co-morbidities such as diabetes, thereby closely resembling the majority of patients in Meso's 566 patient P3 DREAM-HF trial. As Meso said back in 2020, their good results may reflect the effect of MPCs on angiogenesis, inflammation and endolthelial dysfunction. I think it is reasonable to think that younger patients who aren't ischemic and who have LVADs fitted for other reasons don't see the benefit of reducing the persistently elevated levels of the inflammatory cytokine IL-6. The high IL-6 was associated in the ischemic control group with reduced ability to be weaned from LVAD support and by high mortality. Those treated by Meso's cells saw reduction in IL-6 by 2 months and remained low through 12 months.When you read the endpoints of the ischaemic sub-population in the trial, those treated with the cells achieved dramatically better results than the ischaemic controls who did not receive the cells.
E
Aloha.
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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-416
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