The company reported that it expects a review of the 30-day outcomes for this cohort in the third quarter of this year.
The CardiAmp pivotal trial, which launched in December, is slated to enroll up to 260 patients. The study’s primary endpoint is an improvement in six minute walking distance at 12 months after treatment. The researchers will also look at the impact of major adverse cardiac events in the heart failure trial, according to BioCardia.
The San Carlos, Calif.-based company’s CardiAmp cell therapy combines a biomarker panel, a cell processing system for autologous bone marrow-derived cells and a transendocardial delivery system.
BioCardia’s cell therapy system first characterizes the potency of a patient’s own bone marrow cells and determines if the patient is eligble for therapy. A small amount of marrow is collected from the patient’s iliac crest and then processed at the patient’s bedside. The cells are infused using a routine cardiac catheterization procedure with the company’s Helix delivery system.
“Leading clinical sites are actively screening patients for the randomized phase of our Phase III trial, and we are onboarding additional clinical sites in the United States,” chief medical officer Dr. Eric Duckers said in prepared remarks. “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.”