heartdiseasefacts.com
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March 7, 2024
3 minute read
Important points:
- Autologous cell therapy for patients with certain types of heart failure was safe, but there were not enough events to determine efficacy.
- New trials in more sophisticated patient populations are expected to begin.
The researchers reported that autologous cell therapy was safe for heart failure patients with reduced ejection fraction and showed a signal of benefit for patients with elevated baseline N-terminal pro-B-type natriuretic peptide.
CardiAMP HF trial of autologous bone marrow mononuclear cell therapy (CardiAMP, BioCardia) stopped early due to slow enrollment and low event rate, targeting patients with elevated HFrEF and NT-proBNP who had the best response A new trial is scheduled to begin in . For therapy, Dr. Amish Laval, The technology and treatments for heart failure (THT) presented the data at the annual meeting, Director of Cardiovascular Clinical Research and Professor of Medicine at the University of Wisconsin-Madison, told Healio.
The presentation included data from the first 110 patients with HFrEF and ischemic cardiomyopathy (mean age 66 years, 91% male) in a trial testing the safety and efficacy of the treatment. Laval told Helio that the patient was chosen because he had strong bone marrow cells.
The primary endpoints were hierarchical endpoints of cardiac death equivalent (CV death, left ventricular assist device therapy, or heart transplantation), nonfatal major cardiac/cerebrovascular events, and 6-minute walking distance.
Trial has been paused
Amish Laval
“This was a one-time treatment and was expected to be part of the arsenal in addition to guideline-based medical management,” Laval told Helio. “The trial has been suspended by the court.” [data safety monitoring board].The reason for the suspension at that time was that it was difficult to secure staff. [during the COVID-19 pandemic] And because the event rate appears to be low, the company wanted to collect more data on existing patients before deciding what to do next. Both patients [the cell therapy and control] Groups seemed to be doing better. So the sponsor decided to unblind the trial midway through and study what would happen. [data safety monitoring board] I was checking to see if there were any safety issues. The overall approach was found to have no safety concerns and did not actually exceed a prespecified futility threshold for efficacy. It was a practical waste in the sense that it was time consuming and seemed to have a low incidence of events. ”
At 12 months, hierarchical endpoints were similar in both groups (cardiac death equivalent: cell therapy, 5.6%; control, 5.3%; non-lethal MACCE: cell therapy, 12.5%; control, 10.5% , change in 6-minute walking distance from baseline): cell therapy, 36 minutes, control, 33 minutes. P = .64), but for the 92 patients with 24-month data available, the equivalent cardiac death rate was nearly 5 percentage points lower (8.3% vs. 13.2%; P >.05).
“What is interesting is that when we look at patients with NT-proBNP levels above 500 pg/mL, we start to see a separation between cardiac death equivalents and non-fatal MACCE events,” Laval told Helio. Told.
A subgroup analysis of 54 patients with NT-proBNP >500 pg/mL at baseline showed a strong trend in favor of the cell therapy group in the primary stratified analysis at 24 months (cardiac death Equivalents: Cell Therapy, 2.9%, Control), 21.1%, Non-Lethal MACCE: Cell Therapy, 20%, Control, 26.3%, Change in 6-minute walking distance from baseline: Cell Therapy, 19 m, Control; -3 m. P = .07). An analysis in which change in 6-minute walking distance was replaced by change in score on the Minnesota Heart Failure Living Questionnaire was significant (P = .026).
“Change of direction to second trial”
“The decision has now been made to move on to a second trial, the CardiAMP HF II trial, in which bone marrow testing will be performed in patients with NYHA class II or III HF with an ischemic etiology. , and finally inject the cells.” Use the BioCardia Helix catheter up to the border area. It’s all the same,” Laval told Helio. “The difference is that we only select people with elevated NT-proBNP levels of more than 500 pg/mL. Perhaps this selects a sicker population and allows us to demonstrate a difference in events.”
The reason a new trial is necessary is because “there is no clear answer as to whether or not this is the case.” [the therapy] It doesn’t matter if it works or not,” Laval told Helio. “One thing we plan to study more closely is ventricular arrhythmia. Paradoxically, the rate was lower in the cell-treated group than in the control group (7% vs. 13%); We don’t know. One might wonder if injecting an aliquot of cellular material into a pocket of the heart might actually cause an arrhythmia, as studies with other cell types have shown. Although it is small, it is an interesting hypothesis to test in a second trial.”
Information source/disclosure information
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Laval A et al. Day 1 Poster Summary. Presentation location: Technology and Heart Failure Therapies (THT); March 4-6, 2024. Boston.
Disclosure: This study was funded by BioCardia. Mr. Laval reports consulting for BioCardia, Blue Rock Therapeutics, and Novo Nordisk, and serving as co-principal investigator and steering committee member for the CardiAMP HF trial.
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