Emory University School of Medicine, US, has commenced subject enrolment for BioCardia’s Phase III CardiAMP HF II trial of CardiAMP Cell Therapy Product in treating ischemic heart failure.
The trial is assessing BioCardia’s lead product candidate for individuals with ischemic heart failure of minimised ejection fraction and elevated cardiac stress markers.
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This therapy is tailored for harvesting, processing, and delivering autologous mononuclear cells to the heart to improve microvascular density and minimise fibrosis.
The study compares the therapy against a placebo procedure, with all subjects continuing “stable” guideline-directed medical therapy.
Emory University Department of Medicine’s cardiology division professor of medicine Dr Arshed Quyyumi is serving as the principal investigator.
Quyyumi is also co-director at the Emory Clinical Cardiovascular Research Institute.
Last month, the final outcomes were presented from the double-blinded, controlled, randomised CardiAMP Heart Failure trial involving 125 participants.
The findings indicated an increase in survival and a decrease in major adverse cardiac and cerebrovascular events (MACCE) across the study.
The company noted that its regulatory and clinical team is engaging with the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Device Agency to seek approval for the therapy, particularly for subjects with elevated N-terminal pro-B-type natriuretic peptide (NTproBNP).
They are also pursuing separate approval for the Helix transendocardial biotherapeutic delivery system, which holds potential benefits for various biotherapeutic delivery partners.
The therapy combines three elements: a pre-procedural cell analysis for choosing subjects, a high target cell dosage, and a delivery system.
Maryland Stem Cell Research Fund provided support for the CardiAMP clinical development for heart failure.
The US Centers for Medicare and Medicaid Services reimbursed it for both treatment and control procedures.
BioCardia CEO and president Peter Altman said: “We believe this collaboration will assist the company on many levels, including their anticipated strong support in accelerating patient enrolment in the CardiAMP HF II trial towards its target completion in 2027.”
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