CardioWise™ and the National Institutes of Health, National Heart, Lung and Blood Institute Complete Beta Site Agreement for CardioWise Analysis Software
First use will be in NIH clinical research study and protocol to study the use of bone marrow stem cells during cardiac surgery to treat heart muscle dysfunction associated with ischemic heart disease or damage from heart attack.
FAYETTEVILLE, Ark. – Mar. 26, 2014 – CardioWise, Inc. and the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) have signed a Beta Site Agreement to serve as a clinical test site for CardioWise Multiparametric Strain Analysis™ (MPSA™) Software. The CardioWise software will be used in clinical research protocol number 12-H-0078, sponsored by the NHLBI entitled, “Preliminary Assessment of Direct Intra-Myocardial Injection of Autologous Bone Marrow-derived Stromal Cells on Patients Undergoing Revascularization for Coronary Artery Disease (CAD) with Depressed Left Ventricular Function.” The Principle Investigator is Pamela G. Robey, Ph.D., and Dr. Keith A. Horvath is the Cardiothoracic Surgeon on the clinical trial. Details of the study are available here: http://clinicalstudies.info.nih.gov/cgi/wais/bold032001.pl?A_12-H-0078.html@mesenchymal@@@@.
Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated and are found to make large amounts of growth factors. Because they make growth factors, these cells can help regrow tissue and encourage repair of damaged tissue. Tests on damaged heart muscle suggest that injecting these cells directly into damaged heart muscle can improve heart function. Researchers want to give stem cells to people who are having open-heart surgery to see if they can help to repair heart muscle damage. The objectives of the study are to test the safety and effectiveness of bone marrow stromal stem cell injections given during heart surgery to treat heart muscle damage. The CardioWise MPSA software will be used to help to determine the efficacy of the stem cell treatment.
The patients who enroll in the protocol will receive one baseline cardiac MRI (CMR) scan and 3 additional follow up CMR scans. Those CMR scans will be analyzed by CardioWise analysis software and the analyses will be compared to determine whether the stem cell injections can improve the contractile function of the heart muscle. Dr. Andrew E. Arai, Chief of the Advanced Cardiovascular Imaging Research Group in the NHLBI’s Division of Intramural Research will be leading the analysis of the CMR images using the CardioWise MPSA software. Dr. Arai is Past President of the Society of Cardiovascular Magnetic Resonance (SCMR), the leading international professional organization focused on CMR.
The CardioWise analysis software is uniquely capable of analyzing the three-dimensional motion of the heart that is acquired from cardiac MRI images and then comparing the analysis at 15,300 points to the motion of a normal heart model. The analysis detects portions of the heart that are moving abnormally and demonstrates to what degree the heart muscle has been affected. Since MRI uses no ionizing radiation or contrast, it is completely non-invasive and poses minimal risk to the patient. This allows the patient to be followed through the course of treatment and to measure outcomes of interventions such as the stem cell therapy. In the near future, CardioWise MPSA may aid doctors to determine what intervention, such as surgery, stent insertion, or drug is most appropriate for the patient who presents with cardiovascular disease symptoms.
CardioWise™ is commercializing patent-pending, non-invasive Cardiac Magnetic Resonance Imaging (cMRI) analysis software that produces a quantified 3D image model of the human heart, called Multiparametric Strain (MPS™) heart analysis. CardioWise heart analysis software combined with cardiac MRI is a single diagnostic test that is able to provide quantitative analysis of the myocardium, arteries and valves with an unprecedented level of detail. It has the opportunity to become the new gold standard of care for heart health analysis. CardioWise™ is a VIC Technology Venture Development™ portfolio company.