NCT04396899RecruitingPhase 1/2
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 53 (estimated)
- First submitted
- 11 May 2020
- Start date
- 3 Feb 2020
- Primary completion date
- Dec 2027
- Lead sponsor
- University Medical Center Goettingen
- Diseases
- Heart failure
- NCT number
- NCT04396899
- EU CT number
- 2024-515708-38-01
- EudraCT number
- 2019-000885-39
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 53
- From 3 Feb 2020 to the primary completion date, Dec 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected alcohol and/or drug abuse
Other illness
- 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)
Lab values
- 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
Other
- Hypertrophic cardiomyopathy (HCM)
- Simultaneous participation in another interventional trial
- Pregnant or breastfeeding females
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Koeln AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
Related publications
- Stem-Cell-Derived Biologic Ventricular Assist Tissue in Heart Failure.N Engl J Med · 2026 · PMID 42202318
This page is information, not medical advice. Discuss any trial with your doctor.