Actively Recruiting
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
Led by University Medical Center Goettingen · Updated on 2026-02-20
53
Participants Needed
3
Research Sites
408 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Goettingen
Lead Sponsor
D
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic heart failure (NYHA II-IV) with reduced ejection fraction (≤35%) confirmed by echocardiography
- Currently on guideline-directed medical therapy for heart failure
- NT-proBNP levels >300 pg/mL if in sinus rhythm or >900 pg/mL if in atrial fibrillation
- History of heart failure hospitalization within the past 12 months
- Presence of at least one hypo- or dyskinetic heart segment or a dilated heart chamber suitable for implantation
- Stable condition allowing elective left-lateral mini-thoracotomy for left ventricle or open-chest surgery for right ventricle with concomitant dysfunction
- Age between 18 and 80 years
- Willingness and ability to provide written informed consent
- Female participants of childbearing potential must agree to use effective contraception during the study
You will not qualify if you...
- Contraindication to immunosuppressive drugs, including unresolved cancer, hepatitis B/C, HIV, or HTLV1
- Contraindication to TachoSil® due to hypersensitivity to its components
- Diagnosis of hypertrophic cardiomyopathy
- Terminal kidney failure (stage 4) with GFR <30 ml/min at enrollment
- Terminal liver failure (Child-Pugh stage C; score >10) at enrollment
- History of disabling stroke
- Reduced short-term life expectancy due to non-cardiac conditions
- Inability to adhere to study protocol or prescribed medication
- Current participation in another interventional clinical trial
- Pregnancy or breastfeeding
- Known or suspected alcohol or drug abuse
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
2
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Not Yet Recruiting
3
University Medical Center Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23562
Actively Recruiting
Research Team
W
Wolfram-Hubertus Zimmermann, Prof.
CONTACT
F
Florian Walker, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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