PRIME-HFrEF Trial: a randomized, double-blind, multi-dose umbilical cord-derived mesenchymal stem cell regimen for heart failure - PubMed
5 hours ago
- #mesenchymal stem cells
- #clinical trial
- #heart failure
- The PRIME-HFrEF trial evaluated the safety and efficacy of multi-dose intravenous umbilical cord-derived mesenchymal stem cell (UC-MSC) infusions in patients with heart failure and reduced ejection fraction (HFrEF).
- Forty patients were randomized to receive three UC-MSC infusions at six-week intervals or placebo, with 39 completing the 360-day follow-up, showing no significant difference in serious adverse events between groups.
- UC-MSC treatment led to elevated D-dimer levels, indicating increased coagulability, which was negatively correlated with left ventricular ejection fraction (LVEF), but no significant change in LVEF was observed.
- A significant improvement in right ventricular end-systolic volume (ΔRVESV) was noted in the UC-MSC group compared to placebo, suggesting benefits in right ventricular volumes despite transient coagulability effects.