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Phase I/II multi-center, randomized, double-blinded, controlled trial of CardiALLO-cell-therapy in ischemic systolic heat failure

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Trial Profile

Phase I/II multi-center, randomized, double-blinded, controlled trial of CardiALLO-cell-therapy in ischemic systolic heat failure

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 20 May 2025

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At a glance

  • Drugs BCDA 03 (Primary)
  • Indications Ischaemic heart disorders
  • Focus First in man; Therapeutic Use
  • Acronyms Allogeneic NK1R+ MSC Trial in HFrEF
  • Sponsors BioCardia

Most Recent Events

  • 14 May 2025 According to a BioCardia media release,the low dose cohort of 20 million cells in the phase 1/2 clinical trial was completed in the first quarter 2025 .The independent Data Safety Monitoring Board recommended that the study proceed as designed in April 2025 based on the 30-day data safety assessment from this cohort. The Company plans to progress the trial to enrollment of 39 participants in the United States and fund development through nondilutive grant applications and partnering.
  • 13 Nov 2024 According to a BioCardia media release, The last patient in the low-dose cohort is expected to be enrolled in the fourth quarter of 2024 and DSMB safety readout for the low-dose cohort expected in Q1 2025.
  • 27 Mar 2024 According to a BioCardia media release, Completion of low-dose cohort expected in Q2 2024 and completion of medium-dose cohort is expected in Q4 2024.

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