Coronary artery disease is caused by deposits of fat and calcium in the blood vessels that supply the heart with blood. The deposits can become so pronounced that the vessels narrow and the blood flow to the heart muscle is reduced. Then the patient experience chest pain (angina pectoris) and the condition can progress to an acute myocardial infarction and heart failure. This condition is called ischemic heart disease and can be treated with medication, angioplasty of the coronary artery or bypass surgery. A possible future treatment of ischemic heart disease could be stem cells.
Stem cell can be isolated from the the bone marrow and adipose tissue in the abdomen that are capable of forming new blood vessels and heart muscle cells. The cell number is so small in the tissues that the cells should be grown for several weeks before there is enough for the treatment of patients.
We have conducted three clinical stem cell therapy studies in which patients with coronary artery disease has been treated with their own mesenchymal stem cells from either the bone marrow or adipose tissue. Encouraging results are available from two studies and there is ongoing follow-up in the third study. Treatments with stem cells have in all previous studies been without any side effects.
The first study involved 31 patients with coronary artery disease and severe chest pain. Patients have now been monitored for 3 years and during this period they have had reduced chest pain and better quality of life. We have also demonstrated improved pumping function of the heart, greater physical work capacity and fewer hospitalizations caused by heart disease.
Two following studies have been conducted in patients with either heart failure or severe chest pain caused by coronary artery disease. A total of 60 patients were treated in each study with either stem cells or saline in a so-called double-blind placebo-controlled design. In patients with severe heart failure, stem cells from the bone marrow significantly improved the heart’s pumping function, physical exercise capacity and heart problems. The treatment is completed in the last study in patients with ischemic heart disease and severe chest pain. Results are expected at the end of 2015.
We have now learned that with the present methods for culture expansion of the cells and the use of the patient’s own stem cells it can be difficult to propagate stem cell therapy for large groups of patients. There is always an uncertainty as to the number of cells that can be grown from the individual patient and what the length of the culturing period will be. Since there are only a few cell centers approved for clinical stem cell cultivation, there are major logistical and financial difficulties of transporting the patient’s own cells back and forth between the hospital and laboratory. This complicates the planning and deployment of the treatment.
Therefore, the Cardiology Stem Cell Center, Rigshospitalet, Copenhagen, Denmark has removed these obstacles by improving the stem cell cultivation method with the new so-called automatic bioreactors instead of bottles and using stem cells isolated from healthy donors. These cells will be expanded continuously, stored frozen to be ready for patient treatment without any delay. The cells are referred to as Stem Cell Cardiology Centers Adipose-Derived Stem Cells (CSCC_ASC).
We have conducted a safety study with treatment of 10 patients with coronary artery disease and heart failure with stem cells (CSCC_ASC) from three healthy donors produced in Cardiology Stem Cell Center, Rigshospitalet, Copenhagen, Denmark. The stem cells were injected directly into the heart muscle using the same method as in our previous studies. There were no immediate or later side effects to the treatment.