Treed, I have always enjoyed reading your very sensible and reasoned posts. I am not disputing the point you raise. What I would point out is that only a very small subset of end stage heart failure patients ever receive LVADs partly owing to the considerable risks of GI bleeding. Secondly, those patients eligible for bridge to transplant are often a decade younger than end stage and de facto, their physical condition would have made readouts misrepresentative of the destination therapy group anyway. Lastly, the fact that they were receiving transplants, meant de facto, they could not continue to contribute data to the trial..... as they were no longer using their LVADs once they had received transplants. The destination therapy group was the one that really represented our target audience which is why using the same faulty device in both cohort groups frustrated any chance of any meaningful results relating to the primary endpoint of the trial.
The simple truth is that even our stem cells paracrine properties have limitations. Reducing GI bleeding and inflammation as clinically meaningful outcomes for MPC-150-IM is a huge leap forward in treatment options from just a single dose. The idea that patients with advanced heart failure can be weaned off their LVADs from a single dose of our stem cells, was perhaps the NIH getting a little carried away at this stage. I am sure that, given time, MSB's ability to reduce mortality rates to some degree, even in the destination therapy group ,will become self evident.
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