Article Synopsis
- Mesenchymal precursor cells (MPCs) were tested for their safety and effectiveness in treating high-risk heart failure with reduced ejection fraction (HFrEF) in a study involving 565 patients.
- The results showed no significant difference in the primary outcome of recurrent heart-related events between patients receiving MPCs and the control group, although MPCs helped improve heart function in some patients, particularly those with inflammation.
- MPCs reduced the risk of serious cardiovascular issues like heart attacks and strokes, especially in patients with elevated inflammation markers, but overall the primary endpoints of the study were not met.
Video Abstracts
Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Background: Mesenchymal precursor cells (MPCs) are allogeneic, immunoselected cells with anti-inflammatory properties that could improve outcomes in heart failure with reduced ejection fraction (HFrEF).
Objectives: This study assessed the efficacy and safety of MPCs in patients with high-risk HFrEF.
Methods: This randomized, double-blind, multicenter study evaluated a single transendocardial administration procedure of MPCs or sham-control in 565 intention-to-treat patients with HFrEF on guideline-directed therapies. The primary endpoint was time-to-recurrent events caused by decompensated HFrEF or successfully resuscitated symptomatic ventricular arrhythmias. Hierarchical secondary endpoints included components of the primary endpoint, time-to-first terminal cardiac events, and all-cause death. Separate and composite major adverse cardiovascular events analyses were performed for myocardial infarction or stroke or cardiovascular death. Baseline and 12-month echocardiography was performed. Baseline plasma high-sensitivity C-reactive protein levels were evaluated for disease severity.
Results: The primary endpoint was similar between treatment groups (HR: 1.17; 95% CI: 0.81-1.69; P = 0.41) as were terminal cardiac events and secondary endpoints. Compared with control subjects, MPCs increased left ventricular ejection fraction from baseline to 12 months, especially in patients with inflammation. MPCs decreased the risk of myocardial infarction or stroke by 58% (HR: 0.42; 95% CI: 0.23-0.76) and the risk of 3-point major adverse cardiovascular events by 28% (HR: 0.72; 95% CI: 0.51-1.03) in the analysis population (n = 537), and by 75% (HR: 0.25; 95% CI: 0.09-0.66) and 38% (HR: 0.62; 95% CI: 0.39-1.00), respectively, in patients with inflammation (baseline high-sensitivity C-reactive protein ≥2 mg/L).
Conclusions: The primary and secondary endpoints of the trial were negative. Positive signals in prespecified, and post hoc exploratory analyses suggest MPCs may improve outcomes, especially in patients with inflammation.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jacc.2022.11.061 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Effect of intraoperative autotransfusion use during liver transplantation for hepatocellular carcinoma on recurrence-free survival: comparative study with propensity score matching.
BJS Open
September 2025
Digestive Surgery and Transplantation Department, Toulouse University Hospital Centre, Toulouse, France.
Background: Intraoperative autotransfusion remains underutilized in high-risk haemorrhagic oncological procedures, particularly in liver transplantation for hepatocellular carcinoma. This is because of the theoretical risk of tumour cell reinfusion and dissemination, potentially leading to reduced recurrence-free survival. The aim of this study was to evaluate the impact of intraoperative autotransfusion on recurrence-free survival during liver transplantation for hepatocellular carcinoma.
View Article and Find Full Text PDFThe SURVIVE study (NCT05658172): Bringing breast cancer aftercare to the 21stcentury: Study protocol of a Phase III clinical trial comparing liquid biopsy guided vs. Standard of care surveillance for intermediate to high-risk breast cancer survivors.
PLoS One
September 2025
Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.
Background: Current aftercare in breast cancer survivors aims to detect local recurrences or contralateral disease, while the detection of distant metastases has not been a central focus due to a lack of evidence supporting an effect on overall survival. However, the data underpinning these guidelines are mainly from trials of the 1980s/1990s and have not been updated to reflect the significant advancements in diagnostic and therapeutic options that have emerged over the past 40 years. In this trial, the aim is to test whether a liquid biopsy-based detection of (oligo-) metastatic disease at an early pre-symptomatic stage followed by timely treatment can impact overall survival compared to current standard aftercare.
View Article and Find Full Text PDFPyrotinib versus Pertuzumab with Trastuzumab and Taxane in HER2-Positive Metastatic Breast Cancer: A Chinese Multicenter Real-world Study.
Oncologist
September 2025
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, 410013, China.
Background: THP (trastuzumab + paclitaxel + pertuzumab) and THPy (trastuzumab + paclitaxel + pyrotinib) are widely used as first-line regimens for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) in China. However, direct comparative data on their efficacy and safety remain scarce. This study evaluates and compares the clinical outcomes of THPy and THP in the first-line treatment of HER2-positive MBC to guide clinical decision-making.
View Article and Find Full Text PDFRandomized trial of activated vitamin D for acute kidney injury prevention in critically ill patients.
JCI Insight
September 2025
Division of Nephrology, Boston University Chobanian & Avedisian School of Medicine, Boston, United States of America.
Background: Active vitamin D metabolites, including 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D (1,25D), have potent immunomodulatory effects that attenuate acute kidney injury (AKI) in animal models.
Methods: We conducted a phase 2, randomized, double-blind, multiple-dose, 3-arm clinical trial comparing oral calcifediol (25D), calcitriol (1,25D), and placebo among 150 critically ill adult patients at high-risk of moderate-to-severe AKI. The primary endpoint was a hierarchical composite of death, kidney replacement therapy (KRT), and kidney injury (baseline-adjusted mean change in serum creatinine), each assessed within 7 days following enrollment using a rank-based procedure.
One-year outcomes of polymer-free Sirolimus-eluting stents in complex femoropopliteal stenosis: a single center real-world registry.
J Cardiovasc Surg (Torino)
September 2025
Catheterization Laboratory, Montevergine Clinic, Mercogliano, Avellino, Italy -
Background: Lower extremity arterial disease is a prevalent vascular condition leading to ischemic symptoms and increased risk of cardiovascular events. Drug-eluting stents have improved outcomes by reducing restenosis, with sirolimus emerging as a promising alternative to paclitaxel due to its safer profile. This study evaluates the efficacy and safety of novel polymer-free Amphilimus formulation (Sirolimus + fatty acid) eluting self-expanding stent in the treatment of femoropopliteal disease in a real-world population.
View Article and Find Full Text PDF