Cell Therapy Improves Quality-of-Life in Heart Failure: Outcomes From a Phase III Clinical Trial
Satsuki Yamada1, Jozef Bartunek2, Thomas J Povsic3
1Department of Cardiovascular Medicine, Center for Regenerative Medicine, Marriott Heart Disease Research Program, Van Cleve Cardiac Regenerative Medicine Program, Mayo Clinic, Rochester, MN, USA.
Stem Cells Translational Medicine
|November 25, 2023
Summary
Cardiopoiesis-guided cell therapy improved quality-of-life for heart failure patients, particularly those with advanced left ventricular enlargement. This cell therapy also reduced death and hospitalization in this responsive subgroup.
Area of Science:
- Cardiology
- Regenerative Medicine
- Clinical Trials
Background:
- Heart failure significantly impairs patients' daily activities and quality-of-life.
- Traditional outcomes like death and hospitalization do not fully capture patient experience.
- Health-related quality-of-life (HRQoL) monitoring is crucial for comprehensive heart failure assessment.
Purpose of the Study:
- To evaluate the effectiveness of cardiopoiesis-guided cell therapy in improving HRQoL in patients with ischemic heart failure.
- To assess the impact of cell therapy on quality-of-life using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
- To identify patient subpopulations that may particularly benefit from cell therapy regarding HRQoL.
Main Methods:
- A multinational, randomized, double-blinded clinical trial (CHART-1) was conducted.
- Patients with ischemic heart failure and reduced left ventricular ejection fraction received either cell treatment or a sham procedure.
- The MLHFQ was administered at baseline and throughout the 1-year follow-up to measure HRQoL.
Main Results:
- Overall, cell-treated and sham groups showed comparable improvements in MLHFQ scores.
- A significant superiority of cell treatment over sham was observed in patients with advanced left ventricular enlargement (mean difference -6.4 points, P=.009).
- In this responsive subpopulation, improved MLHFQ scores paralleled reduced rates of death and hospitalization (adjusted Mann-Whitney odds 1.43, P=.039).
Conclusions:
- Cardiopoiesis-guided cell therapy may offer benefits for specific heart failure patient groups, particularly in improving quality-of-life.
- Patients with advanced left ventricular enlargement represent a responsive subpopulation for cell therapy.
- Further research is warranted to explore the potential of cell therapy for heart failure symptom relief and improved HRQoL.
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