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

Study acronym: BioVAT-HF
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: 2 to 4 Eligibility criteria expanded, about 59 words · Secondary endpoints expanded, about 67 wordsv6 Show 2 more changesShow less
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints expanded, about 67 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Mar 2024 to Dec 2027 Completion date: Oct 2024 to Dec 2027v5 Show 1 more changeShow less
    • Completion date: Oct 2024 to Dec 2027
  3. Collaborators: 2 to 3v4 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 1 of 3 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Dec 2020 to Feb 3, 2020v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Dec 2020 to Feb 3, 2020
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04396899
Lead Sponsor University Medical Center Goettingen
Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University Medical Center Freiburg, Repairon GmbH
Conditions Heart Failure
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov