Tests heart muscle grown from stem cells in advanced heart failure
Tests stem cell-grown heart muscle implanted in adults with severe heart failure.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
Key facts
- Where
- Cologne, Duesseldorf, Goettingen, Hamburg, Heidelberg, Luebeck, and Munich, GermanySee the 7 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04396899, who can take part
Where in Germany
- Universitaetsklinikum Koeln AöRCologne, GermanyTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyTaking people
- Universitaetsmedizin GoettingenGoettingen, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Goettingen
- Trial code
- NCT04396899EU 2024-515708-38-01
- Record updated
- 20 February 2026
- Original description
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 pluripotent stem cell (iPSC)-derived cardiomyocytes and stromal cells in a bovine collagen type I hydrogel. Comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by EHM implantation. The patient target population for EHM therapy is patients suffering from advanced heart failure with reduced ejection fraction (HFrEF; EF: ≤35%) and no realistic option for heart transplantation.Read full original descriptionShow less
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
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 pluripotent stem cell (iPSC)-derived cardiomyocytes and stromal cells in a bovine collagen type I hydrogel. Comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by EHM implantation. The patient target population for EHM therapy is patients suffering from advanced heart failure with reduced ejection fraction (HFrEF; EF: ≤35%) and no realistic option for heart transplantation.
Inclusion: Symptomatic heart failure (NYHA II-IV) with reduced ejection fraction (HFrEF with LVEF ≤35%) as assessed by echocardiography; Patients on guideline-directed medical therapy; NT-proBNP >300 pg/mL for patients in sinus rhythm or >900 pg/mL if in atrial fibrillation; History of previous heart failure hospitalization in the past 12 months; At least one hypo- or dyskinetic segment or dilated heart chamber to demark the implant target area; (A) Stable disease condition allowing for an elective left-lateral mini-thoracotomy (for LV applications) or (B) open-chest surgery (for RV applications) for a clinically indicated intervention on the LV (e.g., coronary bypass surgery, valve repair, mechanical circulatory support device implantation) with concomitant RV dysfunction, diagnosed using the Tricuspid Annular Plane Systolic Excursion (TAPSE) index <16 mm (Rudski et al. 2010); 18-80 years of age; Willingness and ability to give written informed consent; Female subjects of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration.
Exclusion: Known or suspected alcohol and/or drug abuse; Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1); Terminal liver failure (Child-Pugh stage C; score >10) at the time of enrolment; History of disabling stroke; Reduced life expectancy in the short term due to non-cardiac disease; Any condition that excludes adherence to study protocol (in particular lack of adherence to prescribed medication); Contraindication to TachoSil® (e.g. hypersensitivity to human fibrinogen, human thrombin, horse collagen, human albumin, Riboflavin, Natriumchloride, Natriumcitrate, L-Arginin-Hydrochloride); Terminal kidney failure (stage 4; GFR <30 ml/min) at the time of enrolment; Hypertrophic cardiomyopathy (HCM); Simultaneous participation in another interventional trial; Pregnant or breastfeeding females.