More than three years after a clinical trial was prematurely ended for failing to show progress in healing heart attack scars, a prominent peer-reviewed journal is publishing some surprising results showing that the heart cell treatment does benefit patients.
Data from the ALLSTAR study published Tuesday by the European Heart Journal showed that although infusions of allogeneic cardiac cells—called cardiosphere-derived cells or CDCs--did not appear to shrink the scar left on heart muscle after a heart attack, other data from the study show a clear benefit.
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the All Star trial was designed to see if a different kind of self therapy would actually heal the broken heart. In the sense of the permanently injured heart patients who had a heart attack um develop scar and that scar doesn't go away on its own. The idea of this kind of self therapy was to see if by giving cells the scar might shrink and the heart might function better. So we found that the scar didn't shrink, or at least it didn't shrink any more than it did in patients who got placebo. But the function did get better and the actual volumes of the heart, how much blood the heart could store before each beat. Um didn't change, Which is a good thing because in the placebo patients it got bigger and bigger like an expanding balloon, which is an early form of heart failure. So we are gratified to find that despite the fact that the scar wasn't very much affected, there were these favorable indications in terms of the size of the heart and how much blood it could hold. A more conventional measure of how well the heart is doing over time. Is this amount of blood that stores before each beat. So we designated those as secondary endpoints, we thought, yes, let's look at that too, let's not throw away that valuable information. So even though we were disappointed about the primary endpoint, we were delighted to see that there was a sign, in fact three different signs of what we call disease modifying bio activity. That means these cells that we're giving, we're actually doing something to change the course of the disease. It did um make us realize that we perhaps had bet on the wrong horse. There were 567 or eight horses we could have bet on, we bet on the wrong one to to win, but we did bet on the right one to show. So um so we actually um benefited a lot from the study in the sense that we I don't think it's a negative study, but we had to look closely at the data to realize that it wasn't a negative study. Cd CS, our cardio sphere derived cells and that's just a fancy process name to describe a cell type that originates in the heart and it's kind of like a heart stem cell. It can make more heart cells, it can make more vascular cells and more stem cells, but it comes from the adult heart, not from an embryo. We thought that's the way the cells were working by going into the injured heart and expanding and making new heart muscle. But as we learn more and more, we found the cells were beneficial, but they weren't acting that way. They were acting by secreting factors that coaxed the heart muscle around it to regrow and to function better by mechanisms that are indirect. They would be in principle useful in a variety of diseases where inflammation is out of control. You mentioned. Covid. That's something where we've tested a handful of patients and they were critically ill. We're gratified to see that a number of them recovered fully. Not everyone, but but four out of six in the initial trial had outstanding results.
