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

General Information

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.

Clinical trials phase

Phases 1/2

Start date (estimated)

2020-02-03

End date (estimated)

2024-10-31

Clinical feature

Label	heart failure
Link	http://purl.obolibrary.org/obo/SYMP_0000292

Administrative Information

NCT number

NCT04396899

ICTRP weblink

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04396899

EudraCT number

2019-000885-39

Sponsor Protocol number

02289

Other study identifiers

Name	CTIS2024-515708-38-01
Description	Clinical Trials Information System (CTIS)

Source weblink

https://clinicaltrials.gov/ct2/show/NCT04396899

Regulatory body approval

Name

Paul-Ehrlich-Institut (PEI)

Country

Germany

Public contact

sekretariat.pharma@med.uni-goettingen.de

Public email

sekretariat.pharma@med.uni-goettingen.de

First name

Wolfram-Hubertus

Last name

Zimmermann

Phone

+49 551 395781

Country

Germany

Cells

Which differentiated cell type is used

Label	cardiac muscle cell
Link	http://purl.obolibrary.org/obo/CL_0000746
Description	Cardiac muscle cells are striated muscle cells that are responsible for heart contraction. In mammals, the contractile fiber resembles those of skeletal muscle but are only one third as large in diameter, are richer in sarcoplasm, and contain centrally located instead of peripheral nuclei.; This class encompasses the muscle cells responsible for heart* contraction in both vertebrates and arthropods. The ultrastucture of a wide range of arthropod heart cells has been examined including spiders, horseshoe crabs, crustaceans (see Sherman, 1973 and refs therein) and insects (see Lehmacher et al (2012) and refs therein). According to these refs, the cells participating in heart contraction in all cases are transversely striated. Insects hearts additionally contain ostial cells, also transversely striated muscle cells, but which do not participate in heart contraction.

Recruitment

Recruitment Status

Recruiting

Estimated number of participants