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Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure (CardiAMP Heart Failure Trial)

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Trial Profile

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure (CardiAMP Heart Failure Trial)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2024

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At a glance

  • Drugs CardiALLO cell therapy (Primary)
  • Indications Heart failure
  • Focus Registrational; Therapeutic Use
  • Acronyms CardiAMP HF
  • Sponsors BioCardia
  • Most Recent Events

    • 17 Dec 2024 According to a BioCardia media release, the company expecting final results by the end of the first quarter of 2025.
    • 13 Nov 2024 According to a BioCardia media release,the company expecting topline data and submission to FDA and Japans PMDA in Q1 2025
    • 13 Nov 2024 According to a BioCardia media release, the company intend to request a meeting with the FDA to discuss the results with respect to approvability of the CardiAMP Cell Therapy System .

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