BioCardia has announced the enrolment of the first subject in the randomised, double-blind, placebo-controlled Phase III CardiAMP heart failure (HF) II trial of its autologous cell therapy programme for treating ischemic HF.
The enrolment procedure took place at BayCare Morton Plant Hospital in Clearwater, Florida, US.
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According to the company, the 250-patient multicentre trial is designed to investigate the CardiAMP therapy as a single-time treatment in ischemic HF individuals with decreased ejection fraction (HFrEF) on guideline-directed medical therapy, with elevated levels of N-terminal pro B-type natriuretic peptide (NTproBNP).
This trial employs a primary outcome measure similar to that of the CardiAMP HF study, consisting of three tiers: tier one, all-cause mortality; tier two includes nonfatal major adverse cardiac events; and tier three incorporates a validated quality of life self-assessment tool for patients.
In the CardiAMP HF trial, this efficacy endpoint was met with statistical significance among subjects with elevated NTproBNP levels, who are the central focus of the CardiAMP HF II study.
Improvements in the CardiAMP HF II trial include refined cell population analysis for determining treatment doses, which allows broader subject eligibility, and enhancements to the company’s Helix system with the Morph DNA steerable platform.
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By GlobalDataBioCardia CEO and president Peter Altman said: “We are thankful for the Baycare Morton Plant team led by Dr Miller and Dr Sharma, as well as the many other world-class clinical teams engaged in the CardiAMP cell therapy trials.
“The CardiAMP HF II trial is intended to collect confirmatory evidence to support this autologous cell therapy with respect to approvals, adoption, and reimbursement.”
The CardiAMP cell therapy, which received breakthrough designation from the US regulator, uses an individual’s own bone marrow cells.
Delivered to the heart through a catheter-based procedure, the therapy stimulates the natural healing mechanisms of the body, potentially increasing capillary density, minimising tissue fibrosis, and treating microvascular dysfunction.
BioCardia noted that the CardiAMP clinical development for HF is not only supported by the Maryland Stem Cell Research Fund but also reimbursed by the Centers for Medicare and Medicaid Services (CMS).
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