If you believe this article by Perin,
it could be 'inferred' that the FDA meeting has already happened and he is waiting on the FDA to "approve a new catheter system for injecting the heart with
stem cells and genes" and then the team will proceed with new studies in 2024.....
"This time, his primary endpoint will be tailored to suit the positive outcome he knows he’ll be able achieve. This next round will begin in 2024. "..... Perin
'seems' to know more than Mesoblast .... or more than Mesoblast are letting on ?
https://houston.innovationmap.com/t...&utm_medium=social&utm_source=twitterHouston health care leader on a mission to innovate an end to heart failureEmerson Perin of the Texas Heart Institute, recently published the largest clinical trial of cell therapy for patients with chronic heart failure to-date included 580 patients at 52 sites throughout North America.
“A couple of the patients did remarkably well — more than you could ever expect.
These guys who couldn’t’ walk across the room pretty much were jogging on the beach. That gave me the initial insight that this works,” Perin recalls.
And Perin is proving that there’s a lot of life ahead for heart failure patients. Earlier this year, he published another groundbreaking clinical trial,
DREAM-HF. The largest clinical trial of cell therapy for patients with chronic heart failure to-date included 580 patients at 52 sites throughout North America.
With the goal of getting a new cell therapy approved for heart failure, the primary endpoint was to prove that the therapy could prevent recurrent hospitalizations.
“It was a total negative,” says Perin. That’s because the cells don’t have a decongestant effect such as the medicines currently used to treat heart failure.
But that doesn’t mean that the trial was a failure. Quite the opposite. That’s because Perin and his team proved something else: The trial was able to prove that there was significant improvement in patients with inflammation.
After those patients were injected with mesenchymal precursor cells (MPC), they showed a 70-percent reduction in heart attacks and strokes. Cardiovascular deaths also decreased.These are blockbuster numbers, and big news for patients dealing with heart failure. What it means is that the cells addressed a different aspect of heart failure that until now had been left untreated which was the inflammation — how heart failure starts and what keeps it going.
So what’s next? Going to the FDA.
“They said, ‘We can’t approve it with one trial, but we’ll approve it with two,’” says Perin. This time, his primary endpoint will be tailored to suit the positive outcome he knows he’ll be able achieve. This next round will begin in 2024.Once the FDA approves a new catheter system for injecting the heart with stem cells and genes, the team will proceed with new studies. Gene therapy will be another frontier for Perin — and patients with heart failure.
“I think the combination of cells and genes is even more powerful,” he says. “That will help save lives in a completely new way and do away with heart failure.”
(20min delay)