California-based BioCardia Inc. announced this week positive findings from a clinical trial of its Helical Infusion Catheter System for injecting stem cells into the heart in treatment of chronic ischemic cardiomyopathy.
In a clinical study of 65 ICM patients, researchers used the Helical Infusion system to inject both autologous culture-expanded mesenchymal cells (MSCs) and autologous minimally-processed whole bone marrow mononuclear cells (BMCs), reporting success in meeting endpoints for both therapies with no treatment-emergent serious adverse events (TE-SAEs) reported at 30 days.
"Safety and efficacy outcomes for both combination therapies were encouraging in this Phase II trial," lead investigator Dr. Joshua Hare said in prepared remarks. "We believe a high dosage of 200 million cells delivered in a stable and precise way with the Helical Infusion Catheter System is contributing to these positive results."
The results may provide a foundation for further research and larger trials, the study authors said in a paper published this week in the Journal of the American Medical Assn. and presented during the American Heart Association’s 2013 Scientific Sessions.
During the 30 days following treatment, investigators reported no incidence of death, non-fatal myocardial infarction, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade or sustained ventricular arrhythmias, according to a press release. The doctors reported 100% technical success in performing the procedure and there were no cases of post-procedural pericardial effusion.
The BMC arm of the trial remained free of adverse events out to 12 months, with 1 event reported in the MSC group and 2 in the placebo group. There were 2 deaths in the year following treatment, 1 in the MSC arm and 1 in the placebo arm, and re-hospitalization rates were similar for all arms of the study, according to the report.