FREEDOM Trial Status: Active; Not Recruiting. For more information, please visit (Identifier: NCT04614467)

Do you experience frequent chest pain (angina), but are told you have "normal" (or non-obstructed) coronary arteries? The FREEDOM Trial is testing the use of an investigational cell therapy using a patient’s own cells to reduce angina. This trial may be an option for you.

Coronary microvascular dysfunction (“CMD”) is a type of heart disease affecting the tiny (micro) arteries in your heart, unlike more familiar types of heart disease which affect the larger arteries. 1 People with CMD experience frequent chest pain (also called angina) during normal daily activities (e.g. shopping, cooking and going to work), but the underlying cause of their chest pain is different from that caused by more common types of heart disease.

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 your chest (or neck or shoulders or even upper abdomen) and occurs when your heart muscle is not getting enough oxygen-rich blood.  2 This is typically caused by plaque build-up in large arteries blocking the flow of blood. 3 Patients with CMD, however, show no signs of plaque build-up in the large blood vessels (arteries) that supply the heart. These traditional tests (such as an “angiogram”) are only able to “see” problems with the large arteries of the heart and are not designed to detect issues with the tiny (micro) coronary (heart) arteries. However, in patients with CMD, the walls of these tiny coronary arteries are damaged or diseased, reducing flow of blood to your heart muscle 4 resulting in the symptom of chest pain.


What is the FREEDOM Trial?

If you experience chest pain on a weekly basis, but you have been told by a physician that your arteries appear “normal,” you may be a candidate for the FREEDOM Trial. The study is evaluating XOWNA® (CLBS16), a type of cell therapy using your own cells to potentially repair damage to the coronary arteries. The XOWNA® treatment is delivered via a minimally invasive, catheter-based procedure. As with all clinical research trials, participation is voluntary, and no direct medical benefit can be guaranteed; however, it is possible that by participating in this study, you could see an improvement in your condition. Possible risks or discomfort related to the study procedures or treatment will be thoroughly discussed by a study physician prior to your participation. Serious complications are considered rare and will be minimized as much as possible by the study staff conducting this research.

What is XOWNA®?

XOWNA® 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 special 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. Bone marrow is a soft substance found in the center of most bones in our bodies, and it is in the bone marrow that our body creates new blood cells. 5 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.

XOWNA® 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-obstructive” arteries). XOWNA® 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 tiny (micro) blood vessels, called microvasculature. The treatment is delivered via a minimally invasive, catheter-based procedure.

The entire XOWNA® treatment procedure takes about 7 days (following a screening period to determine if you are eligible to join the study). First, you will receive a special medication via injection daily for 5 days to help stimulate the bone marrow to produce more CD34+ cells and mobilize some of them from the bone marrow into the blood circulating in your body. Then, a procedure (called “apheresis”) is performed to collect a portion of your blood (like donating blood) over the course of a few hours. The collected blood is sent to a special facility and undergoes a process to purify the cells to be transferred to your heart. The cells are not modified in any way. Finally, on the day of treatment, one tiny incision is made in your groin (upper thigh) or wrist and a very thin, flexible tube (called a “catheter”) is inserted into your heart. The catheter delivers the XOWNA® cell therapy directly to the damaged areas of your heart.

Only select treatment centers in the U.S. are conducting this new research study (FREEDOM Trial). If you currently experience chest pain on a weekly basis and have normal arteries, you may qualify for this study.