What is chest pain (angina) and why does it occur?
Chest pain or discomfort (also known as angina) is a common symptom of heart disease. It is often described as a feeling of squeezing or tightness in the chest (or neck or shoulders or even upper abdomen) and occurs when the heart muscle is not getting enough oxygen-rich blood. This is typically caused by plaque build-up in large arteries blocking the flow of blood. Patients with CMD, however, show no signs of plaque build-up in the large blood vessels (arteries) that supply the heart. Traditional tests such as an angiogram are only able to visualize problems with the large arteries of the heart and are not designed to detect issues with the microvasculature. However, in patients with CMD, the walls of the microvasculature are damaged or diseased, reducing blood flow to the heart muscle resulting in the symptom of chest pain.
What is the ESCaPE-CMD Trial?
Patients who experience chest pain on a weekly basis, but whose arteries appear “normal” may be candidates for the ESCaPE-CMD Trial. The study is evaluating CLBS14, a type of cell therapy using a patient’s own cells to potentially repair damage to the coronary arteries. The CLBS14 treatment is delivered via a minimally-invasive, catheter-based procedure. As with all clinical research trials, no direct medical benefit can be guaranteed; however, it is possible that by participating in this study, patients could see an improvement in their condition. Serious complications are considered rare.
What is CLBS14?
CLBS14 is a cell therapy that is made from a patient’s own blood cells, specifically, special blood vessel forming cells called CD34 cells, that are collected from each patient and then purified in a lab using a magnetic separation technique. CD34 cells are a special blood cell that has been shown to have the ability to stimulate the growth of new blood vessels. These cells are found abundantly in everyone’s bone marrow. Doctors and researchers have studied these bone marrow cells for years and have learned that they play an important part in the body’s natural healing process.
CLBS14 is composed of a patient’s own CD34 cells and is intended for people who experience frequent chest pain due to a lack of blood supply to the heart. This lack of blood supply to the heart is the result of disease in the small blood vessels that the CD34 cells have been shown to help regrow. In patients with CMD, the cause of their chest pain is not due to blocked arteries (in other words, patients with CMD have “normal” or “non-obstructed” arteries). CLBS14 is an investigational therapy (meaning it has not yet been approved by the FDA for use outside this study) that uses a patient’s own cells to potentially repair damage to the microvasculature. The treatment is delivered via a minimally-invasive, catheter-based procedure.
The entire CLBS14 treatment procedure takes about 7 days (following a screening period to determine patient eligibility to join the study). First, patients will receive granulocyte-colony stimulating factor (GCSF; filgrastim) via injection daily for 5 days to help stimulate the bone marrow to produce more CD34 cells and mobilize them from the bone marrow into the peripheral blood. Then, apheresis is performed to collect the mononuclear cells from the patient’s blood. The mononuclear cells are sent to a special facility and undergo a magnetic separation process to select the CD34+ cells. The cells are not modified in any way. Finally, on the day of treatment, the cells are delivered to the patient via an infusion into a coronary artery in the catheterization laboratory. The catheter delivers the CLBS14 cell therapy directly to the damaged areas of the patient’s heart.