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Published on: January 23, 2021
Stem-Cell-Derived Biologic Ventricular Assist Tissue in Heart Failure.
Wolfram-Hubertus Zimmermann1,2,3,4,5,6, Stephan Ensminger7,8, Ingo Kutschka2,9
1Department of Pharmacology and Toxicology, University Medical Center Göttingen, Göttingen, Germany.
The New England Journal of Medicine
|May 27, 2026
Summary
Biologic ventricular assist tissue (BioVAT) shows promise for cardiac remuscularization, improving heart wall thickness and ejection fraction in heart failure patients. Further research is needed due to adverse events observed in the interim analysis.
Area of Science:
- Regenerative Medicine
- Cardiovascular Research
- Biotechnology
Background:
- Biologic ventricular assist tissue (BioVAT) utilizes engineered heart muscle from allogeneic induced pluripotent stem cells.
- It is designed for cardiac remuscularization in heart failure patients with reduced ejection fraction.
Purpose of the Study:
- To evaluate the safety and efficacy of BioVAT transplantation in patients with heart failure.
- To assess changes in heart wall thickness, left ventricular ejection fraction, and quality of life.
Main Methods:
- An open-label, phase 1-2 study involving BioVAT transplantation with varying doses (5, 10, or 20 units).
- Patients received immunosuppression; safety assessed via adverse events.
- Primary efficacy endpoints included heart wall thickness, ejection fraction, and KCCQ-OSS.
Main Results:
- The study treated 20 patients; 16 received the maximal safe dose.
- Significant increases observed in target heart-wall thickness (4.5 mm) and left ventricular ejection fraction (3.9 percentage points) at 3 months.
- Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OSS) showed a trend towards improvement (6.7 points); all patients experienced adverse events.
Conclusions:
- Interim analysis suggests BioVAT cardiac remuscularization increases heart wall thickness, ejection fraction, and KCCQ-OSS.
- All patients experienced at least one adverse event, necessitating longer-term follow-up.
- Further clinical investigation is warranted to confirm safety and efficacy.
