Studies Presented for BioCardia’s CardiAMP Cell Therapy
February 22, 2016—BioCardia, Inc. announced that two presentations related to the company’s CardiAMP cell therapy were presented at CRT 2016, the Cardiovascular Research Technologies meeting being held in Washington, DC.
According to the company, the CardiAMP cell therapy for the treatment of ischemic systolic heart failure is the first cardiac cell therapy to enter pivotal trials under an investigational device exemption (IDE) and the first to utilize an inclusion criteria assay of patient cell composition. Medicare has approved the CardiAMP IDE, allowing coverage of the cell therapy and the routine care items and services in the trial.
Martin W. Bergmann, MD, from Hamburg, Germany, presented the clinical results of the ALSTER HELIX phase 1 study, which is assessing the safety and efficacy of the delivery of BioCardia’s CardiAMP bone marrow cell therapy directly into the heart muscle from within the chamber of the heart between 21 and 45 days after onset of acute myocardial infarction.
In the company’s press release, Dr. Bergmann explained the background, methods, and findings of the study:
Despite highly efficient and timely percutaneous revascularization, some patients suffer from early onset heart failure symptoms after myocardial infarction most often due to a delay between symptom onset and the patient turning to medical care.
These patients are at high risk for deteriorating heart function leading to shortness of breath and fatigue with everyday activities. Regenerative heart therapy may have its biggest impact in this vulnerable phase of myocardial scarring following an infarct, yet intracoronary cell therapy was found to be ineffective.
Direct intramyocardial delivery has long been recognized as more efficient for cardiac bone marrow cell therapy yet the field has shied away from employing this approach in post infarct patients due to the associated complex workflow and theoretic safety issues.
Our workflow included cardiac magnetic resonance imaging (MRI) more than 1 week after successful revascularization allowing for precise analysis of heart function and myocardial thickness. The procedure was scheduled at around 4 weeks after percutaneous coronary intervention.
We performed this feasibility study with the Helix biotherapeutic delivery platform, because of its inherent ease of use, demonstrated safety profile in hundreds of heart failure patients in numerous clinical trials, and improved efficiency.
With Helix for delivery, and a point-of-care cell-processing platform, in a single, inexpensive 1-hour procedure, we were able to harvest, process, and deliver a dosage of autologous marrow cells to patients with reduced heart function and symptoms of heart failure despite successful revascularization.
ALSTER HELIX results presented showed no safety issues in nine patients treated. While the patients were at high risk of deteriorating heart function based on their initial cardiac MRI, we found a statistically significant and clinically meaningful improvements at 12-month follow-up in New York Heart Association class (2.6 ± 0.5 to 1.3 ± 0.5; P = .0002), improvements in brain natriuretic peptide levels (362.1 ± 340.4 to 58.9 ± 45.9 ng/l; P = .036), and improvements in left ventricular ejection fraction (40.1% ± 8% to 47.4% ± 9%; P = .02).
These results support that intramyocardial injection of bone marrow-derived cell therapy using Helix can be used safely in patients with symptomatic heart failure following acute ischemic events. Cell therapy in this subgroup of infarct patients should be studied in a larger randomized controlled trial.
The highly efficient delivery of 150 million cells, likely the highest effective dosage ever delivered in this clinical setting through the intramyocardial route, might allow us to overcome previous hurdles with this therapeutic approach.
On February 23, Peter A. Altman, PhD, BioCardia’s Chief Executive Officer, will present the CardiAMP phase 3 heart failure trial at CRT’s featured Cardiovascular Innovations Symposium. The trial will test a novel comprehensive solution for autologous progenitor and stem cell therapy that includes the CardiAMP potency assay, CardiAMP cell separator point-of-care processing platform, and the Helix transendocardial delivery system. In November 2014, the company announced that the phase 3 trial’s protocol had been approved by the US Food and Drug Administration.
Dr. Altman commented in the company’s press release, “CardiAMP therapy is based on the role bone marrow cells have in the normal cardiac repair process after an injury to the heart. The CardiAMP program in heart failure presents a potential solution to issues with autologous cell variability. Dr. Bergmann’s new study provides our first clinical support for partners working in this indication using Helix as a delivery solution. It may enable CardiAMP cell therapy to advance in the indication of acute infarction under the same regulatory pathway with the Medicare reimbursement designation that CardiAMP cell therapy has for the indication for heart failure.”