It’s American Heart Association(AHA) meeting week in Dallas, Texas, and cardiovascular regenerative medicine company BioCardia®, Inc. has updated us on trial results from its stem cell studies, as reported both at the congress and concurrently the Journal of the American Medical Association (JAMA).
This is, to all intents and purposes, a stem cell study, talking of 12 month results from the randomized Transendocardial Autologous Cells (MSC or BMC) in Ischemic Heart Failure Trial (TAC-HFT). TAC-HFT is a Phase II trial designed to investigate the safety of transendocardial stem cell injections (TESI) into the heart wall in the treatment of chronic ischemic cardiomyopathy (ICM).
But being device people, we’re interested in the delivery system.
BioCardia’s Helical Infusion Catheter System™ is the means by which stem cells are delivered to the target muscle. It comprises a steerable, two-catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart. The system claims a number of performance advantages include crossing the aortic valve over a wire to prevent damage, enhanced navigation using the company’s super-thin walled, steerable Morph® guiding catheter, a helical needle which screws into the myocardium for stable delivery, and the use of contrast in the needle to confirm tissue engagement. Further, the system requires no external capital equipment and claims an excellent clinical safety profile. The system has received CE Mark and is commercially available in the EU. The system is currently being used for investigational biotherapeutic programs in the United States and is not approved for sale in the U.S.
The two types of stem cell being compared in the study are autologous culture-expanded mesenchymal cells (MSCs) and autologous minimally-processed whole bone marrow mononuclear cells (BMCs). The reason this is interesting is that the findings may have implications for commercialization of the therapies: if the inexpensive BMC therapy, which can be completed in one day, is as safe and performs similarly to MSCs, which are significantly more expensive and take weeks to process, it could be a viable and more convenient option for patients.
And in essence it looks like it’s so far so good in that regard. Both therapies met the primary endpoint of the trial by demonstrating no incidence of treatment-emergent serious adverse events (TE-SAEs) at 30 days. While sample sizes and multiple comparisons meant the results weren’t definitive, the results presented at AHA and the JAMA publication suggested both therapies yielded results that warrant further, more extensive testing.
The technical success of transendocardial infusion with the Helical Infusion Catheter was 100 percent by the way.
More detail on the trial can be found at: http://clinicaltrials.gov/ct2/show/NCT00768066.
“Safety and efficacy outcomes for both combination therapies were encouraging in this Phase II trial,” said presenter and lead investigator Joshua Hare, MD from the University of Miami . “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.”
“In our second head-to-head trial of two fundamentally different bone marrow cell therapies, both the minimally-processed and culture-expanded therapies showed clinical benefit to patients in positive, placebo-controlled data sets,” said BioCardia Chief Executive Officer Peter Altman. “With these results, we look forward to approval of a pivotal trial where we, working in partnership with the University of Miami and others, will join the ranks of the three already-approved pivotal trials studying the promising potential of intramyocardial delivery of bone marrow-derived cell formulations in the treatment of cardiovascular disease.”
Source: BioCardia, Inc.