As co-national principal investigator of the ongoing CardiAMP Heart Failure Trial testing use of personalized stem cells for treatment of heart failure, Amish Raval, MD, associate professor, Cardiovascular Medicine, provided an update on the trial in a news release. 

According to the report, an independent data safety monitoring board completed the pre-specified interim analysis of safety outcomes for the first 10 patients treated in the trial. No safety concerns were found and the trial was recommended to continue. 

"This minimally invasive, point of care approach has the potential to revolutionize the treatment of ischemic heart failure. We are now recruiting for the randomized, controlled pivotal trial, which is designed to test the hypothesis that transendocardial delivery of autologous bone marrow mononuclear cells to patients, who are pre-selected with high bone marrow potency markers, will improve Six Minute Walk distance and other clinically relevant endpoints," said Dr. Raval.

Resources:

• "BioCardia Announces Successful Interim Safety Analysis in Its Phase 3 Clinical Trial of CardiAMP Stem Cell Therapy for Heart Failure," BusinessWire, September 27, 2017
• "Dr. Amish Raval leads trial of stem cell therapy for heart failure," Department of Medicine, May 30, 2017
• CardiAMP™ Heart Failure Trial - ClinicalTrials.gov