BioCardia has revealed the trial design for its pivotal Phase III CardiAMP Heart Failure Trial at the Texas Heart Institute International Symposium on Cardiovascular Regenerative Medicine (15–16 September, Houston, USA).
The CardiAMP Heart Failure trial is a Phase III, multicentre, randomised, double-blinded, sham-controlled study at 40 centres nationwide of up to 260 patients will assess the use of the use of stem cells with CardiAMP therapy (BioCardia) for the treatment of heart failure associated with myocardial infarction.
The trial’s primary endpoint is improvement in six-minute walking distance at 12 months post-treatment. Additionally, the primary endpoint analysis incorporates the impact of major adverse cardiac events and other clinically meaningful events.
A press release reports that CardiAMP therapy, an investigational product, takes a personalised and minimally-invasive approach to the use of stem cells for treating heart failure from a heart attack, learning from unsuccessful methods that have come before. By screening for patients with a higher likelihood of benefiting from treatment and delivering a high target dose of 200 million of a patient’s own bone marrow cells directly to injured cardiac tissue using a proprietary delivery system, CardiAMP therapy is designed to stimulate the body’s natural healing response.
BioCardia chief medical officer Eric Duckers, says: “We have designed the CardiAMP therapy and pivotal trial to study a new approach to using bone marrow stem cells to address heart failure. Recognising that earlier bone marrow cell therapies have been unsuccessful or inconclusive, we have learned from others’ experience. CardiAMP therapy incorporates a proprietary biomarker screening test to identify patients at a higher likelihood of benefiting from therapy before delivering it, which is designed to optimize outcomes and improve upon earlier results.”
He adds: “We target a high dose of 200 million stem cells, as a high dosage has been associated with improved heart function in previous studies and may improve the opportunity to impact target tissue. Lastly, by using autologous bone marrow cells rather than donor cells, we may improve the body’s acceptance of the therapy and minimize infection risk and complications.”
According to the press release, Earlier CardiAMP studies—including the Phase II TAC-HFT-BMC trial—have shown an excellent safety profile with statistically significant improvements in patient quality of life and functional capacity. Delivery of stem cell therapy to the heart using the Helix transendocardial delivery system incorporated in CardiAMP therapy has been shown to result in superior cell delivery than either percutaneous intra-coronary infusion or direct injection in an open chest procedure.