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Phase I/II Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (hMSCs) in Patients With Ischemic Heart Failure With Reduced Ejection Fraction (HFrEF)

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Trial Profile

Phase I/II Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (hMSCs) in Patients With Ischemic Heart Failure With Reduced Ejection Fraction (HFrEF)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 22 Apr 2025

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At a glance

  • Drugs CardiALLO cell therapy (Primary)
  • Indications Left ventricular dysfunction
  • Focus Adverse reactions
  • Acronyms CardiALLO; CardiALLO MSC
  • Sponsors BioCardia

Most Recent Events

  • 15 Apr 2025 Results presented in a Biocardia Media Release.
  • 15 Apr 2025 According to a BioCardia media release, success in this trial can enable future pivotal trial design and funding in the USA, conditional time limited approval with reimbursement in Japan, as well as the advancement of CardiALLO MSC therapy for the likely orphan indications of pediatric and adult congenital heart disease.
  • 15 Apr 2025 According to a BioCardia media release, Independent Data Safety Monitoring Board (DSMB) recommends that the study proceeds as designed based on 30-day data safety assessment of participants treated in low dosage group. The company plans to progress the trial to enrollment of 39 participants in the United States.

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