Atherosclerosis is a potentially serious occurrence where arteries become clogged with fatty substances called plaques, or atheroma. These plaques cause the arteries to harden and narrow, restricting the blood flow and oxygen supply to vital organs, and increasing the risk of blood clots that could potentially block the flow of blood to the heart or brain.
Atherosclerosis and its clinical manifestations, such as coronary artery disease (CAD), are the leading cause of death in Western countries. It is a multifactorial disease characterized by endothelial dysfunction, smooth muscle cell proliferation and migration, inflammation, lipid and matrix accumulation and thrombus formation. The most common manifestation of CAD is angina pectoris, caused by impaired blood flow to the muscle of the heart due to occluding plaques in coronary vessels.
Major risk factors for CAD include increasing age, a family history of premature CAD, cigarette smoking, hypertension and diabetes.
To assist health care providers in prevention and treatment of CAD the patients can be stratified according to their total risk profile. Thus, the treatment strategies for CAD patients are targeted to influence the individual risk factors present through dietary and drug therapy and by changes in lifestyle.
In recent years coronary angioplasty and stenting have become an important treatment method for severe CAD. Over the last decade, the annual frequency of percutaneous coronary interventions (PCI) has risen exponentially. The increased experience and developed equipment have resulted in an improved primary success rate of over 97 percent. Despite the fact that better treatment methods have been developed for CAD there remains a continuously increasing group of so called refractory angina patients who constitute a serious clinical problem. The European Society of Cardiology has recently emphasized this important clinical problem and defined refractory angina as a chronic condition (> 3 months) characterized by the presence of angina caused by coronary insufficiency due to CAD which cannot be controlled by a combination of medical therapy, angioplasty and coronary bypass surgery.
Despite the fact that better treatment methods have been developed for CAD patients in general, this group of patients suffer from significant symptoms and disability even with maximal medication. These patients, who constitute up to 5% of severe CAD patients in Cardiology Clinics in the EU and USA, are not eligible for any coronary interventions due to factors such as diffuse stenosis (spread over a wide area), small coronary vessels, repeated coronary operations and being too high risk for the operation. Thus, there is a significant unmet clinical need to develop new therapies for this rapidly increasing group of patients.
Our regenerative therapy aims to meet this clinical need and offer a treatment, not only for the refractory group of patients for whom medical therapy, angioplasty and coronary bypass surgery have failed to control the disease, but also for patients much earlier in the treatment pathway.