Stem cell therapy using Helix transendocardial delivery system provides better results, study shows

BioCardia, Inc. today announced publication of a study in the International Heart Journal. According to the study, delivery of stem cell therapy to the heart using the Helix transendocardial delivery system results in superior cell delivery than either percutaneous intra-coronary infusion or direct injection in an open chest procedure.

Use of the Helix system resulted in 18 times higher retention of injected cells in the myocardium than intra-coronary artery infusion, and three times higher than direct injection to the heart using a straight needle. Yoshiake Mitsutake, MD from Stanford University's Division of Cardiovascular Medicine was the lead author of the article.

The authors commented, "Our study indicated that the efficacy of cell delivery using a transendocardial helical infusion delivery system was more efficient than either transepicardial injection or intra-coronary infusion. The Helix transendocardial delivery system has the potential to improve local cell delivery and retention in cardiovascular cell-based therapy, thus potentially improving clinical outcomes."

Recognizing that there have been variable results for stem cell therapies for cardiovascular disease to date, the authors, who included researchers from BioCardia and Stanford University, intended to study the impact of optimizing the delivery method on cell retention, as a potential strategy to improve patient outcomes. In this pre-clinical study, 12 swine subjects underwent collection of bone marrow cells and delivery of processed stem cells via one of the three delivery methods. PET-CT images were acquired one hour after cell injections to determine cell retention.

The Helix system is used in the company's investigational CardiAMP® therapy, which is designed to deliver a high dose of a patient's own bone marrow cells directly to the point of cardiac dysfunction, potentially stimulating the body's natural healing mechanism after a heart attack. The therapy, including the Helix system, is currently being studied in the U.S. in the CardiAMP Heart Failure Trial, a phase III, multi-center, randomized, double-blinded, sham-controlled study which is enrolling up to 260 patients at up to 40 centers nationwide. For information about eligibility or enrollment in the CardiAMP Trial, please visit www.clinicaltrials.gov or ask your cardiologist.

The Helix system is actively being used, or has been used, in nine other clinical trials, including EXCELLENT (EXpanded CELL ENdocardiac Transplantation), RECARDIO (Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy), and TRIDENT (TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis Study).

The company recently entered into new agreements, or amended existing agreements, with AstraZeneca and the University of Washington with respect to evaluating the Helix system for their therapeutic programs.

"The Helix system is an integral part of our investigational CardiAMP therapy, and we are pleased to see these promising results relative to how it may improve tissue retention of cell therapy," said BioCardia Chief Executive Officer Peter Altman. "We look forward to continued enrollment in our CardiAMP Phase III trial to understand how the investigational therapy may help U.S. heart failure patients in need."