Loading clinical trials...

Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure

NCT04396899•University Medical Center Goettingen

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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. History of previous heart failure hospitalization in the past 12 months
•5. At least one hypo- or dyskinetic segment or dilated heart chamber to demark the implant target area
•6. (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).
•7. 18-80 years of age
•8. Willingness and ability to give written informed consent
•9. Female subjects of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration.

Exclusion Criteria

•1. Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1)
•2. Contraindication to TachoSil® (e.g. hypersensitivity to human fibrinogen, human thrombin, horse collagen, human albumin, Riboflavin, Natriumchloride, Natriumcitrate, L-Arginin-Hydrochloride)
•3. Hypertrophic cardiomyopathy (HCM)
•4. Terminal kidney failure (stage 4; GFR \<30 ml/min) at the time of enrolment
•5. Terminal liver failure (Child-Pugh stage C; score \>10) at the time of enrolment
•6. History of disabling stroke
•7. Reduced life expectancy in the short term due to non-cardiac disease
•8. Any condition that excludes adherence to study protocol (in particular lack of adherence to prescribed medication)
•9. Simultaneous participation in another interventional trial
•10. Pregnant or breastfeeding females
+1 more criteria

Locations (3)

University Medical Center Göttingen

Göttingen, Lower Saxony, Germany

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, Germany

University Medical Center Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Key Dates

Start Date

February 3, 2020

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

February 20, 2026

Enrollment

ESTIMATED participants

Conditions

Heart Failure

Interventions

EHM implantation

BIOLOGICAL

Contacts

Wolfram-Hubertus Zimmermann, Prof.

CONTACT

+49 551 / 3965781 sekretariat.pharma@med.uni-goettingen.de

Florian Walker, Dr.

CONTACT

+49 551 / 3960825 biovat@med.uni-goettingen.de

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

RECRUITINGNA

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

NCT07484009

Acute Heart Failure (AHF)Heart Failure (for Example, Fluid Overload)+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

Respiratory Virus Infections in Acute Heart Failure