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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: 30 Aug 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

    • 13 Aug 2024 According to a BioCardia media release, the company expects final patient follow-up data in late Q3 2024.
    • 27 Mar 2024 According to a BioCardia media release, Research and development decreased to $7.7 million in 2023, compared to $8.8 million in 2022, primarily due to the recent pause of the CardiAMP Cell Therapy Heart Failure Trial and its subsequent completion of enrollment coupled with reduced expenses in clinical and related supporting functions.
    • 27 Mar 2024 According to a BioCardia media release, company anticipates completing follow-up in the trial and preparing this dataset on 115 randomized patients enrolled with a minimum of one-year follow-up for final lock in the fourth quarter of 2024. This data may be sufficient to support product approval in Japan.

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