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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2017

At a glance

  • Drugs Bone marrow cell therapy (Primary)
  • Indications Heart failure
  • Focus Registrational; Therapeutic Use
  • Sponsors BioCardia
  • Most Recent Events

    • 26 Jul 2017 According to a BioCardia media release, The company anticipates filing an investigational device exemption (IDE) supplement to add an interim efficacy readout in the fourth quarter of 2018 and expects top line data in the fourth quarter of 2019.
    • 26 Jul 2017 According to a BioCardia media release, treatment for the 10-patient roll-in cohort for this trial has been completed and a pre-specified review of the 30-day outcomes in this cohort by the Data Safety Monitoring Board is anticipated in the third quarter of 2017.
    • 28 Feb 2017 According to joint media release by Johns Hopkins Medicine, Maryland Stem Cell Research Fund and BioCardia Inc., the first patient has been treated in this trial.
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