BioCardia® Helix Results in Higher Stem Cell Retention in Myocardium

BioCardia®, Inc. tells us about a newly published study in the International Heart Journal. The study says 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.


Results of stem cell therapies for cardiovascular disease have been variable, prompting researchers from BioCardia and Stanford University to study the impact of optimizing the delivery method on cell retention. In so doing they hope to offer 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.

One of these methods is the BioCardia Helix system, designed to deliver the company’s CardiAMP® and CardiALLO® biotherapeutic product candidates, currently in clinical development. The therapy 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.

In the study, use of Helix 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.

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).

Investigator comments

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.”

Company comments

“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.”

Reference: Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart. Int Heart J. 2017. 16-179.

Source: BioCardia®, Inc.

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