According to a study published in the International Heart Journal, delivery of stem cell therapy to the heart using BioCardia’s 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 an 18 times higher retention of injected cells in the myocardium than use of intra-coronary artery infusion, and a three times higher retention than use of direct injection to the heart using a straight needle. Yoshiake Mitsutake from Stanford University’s Division of Cardiovascular Medicine, Stanford, USA, was the lead author of the article.
The authors comment, “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.”
Recognising 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 optimising 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 US in the CardiAMP Heart Failure Trial, a phase III, multi-centre, randomised, double-blinded, sham-controlled study which is enrolling up to 260 patients at up to 40 centres nationwide.
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).
