Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
Recruiting
Phase 1
Phase 2
Interventional Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 53 (estimated)
- Sponsor
- University Medical Center Goettingen · Other
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About This Trial
The BioVAT-HF trial will test the hypothesis that cardiomyocyte implantation via engineered heart muscle (EHM), the proposed investigational medicinal product (IMP; designated "Biological Ventricular Assist Tissue" or BioVAT), results in sustainable remuscularization and biological enhancement of myocardial performance in the failing heart. EHM are constructed from defined mixtures of induced plur…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Symptomatic heart failure (NYHA II-IV) with reduced ejection fraction (HFrEF with LVEF ≤35%) as assessed by echocardiography.
2. Patients on guideline-directed medical therapy
3. NT-proBNP \>300 pg/mL for patients in sinus rhythm or \>900 pg/mL if in atrial fibrillation
4. Hi…
Contacts
Wolfram-Hubertus Zimmermann, Prof.
+49 551 / 3965781
sekretariat.pharma@med.uni-goettingen.de
CONTACT