THE PROCEDURE

If you participate in the ATHENA Clinical Trial, what can you expect?

Once you have agreed to participate in the ATHENA clinical trial and been deemed eligible by the study doctor, a time will be scheduled for you to be admitted to the hospital for the procedure. The procedure consists of 3 phases: 1) liposuction to collect approximately 1½ cups of fat from your body, 2) preparation of your ADRCs, and then, 3) injection of your ADRCs (or placebo) into the damaged areas of your heart.

Illustration
  1. At the start of the procedure, all trial participants (including those who will receive placebo) will undergo a liposuction procedure to remove approximately 1½ cups of their adipose (fat) tissue. This procedure will be conducted under either local or general anesthesia. This will be determined by your study doctor in discussion with you.
  2. The fat tissue collected from you is then processed using investigational Celution® technology to prepare ADRCs. During the ADRC preparation time you will be resting.
  3. After the preparation of your ADRCs is complete, the cardiologist will create a map of your heart using a standard heart catheterization procedure so that he knows where to make injections. The appropriate study treatment (your ADRCs or placebo) will then be injected into the damaged heart tissue using an investigational catheter-based procedure which is specifically designed for heart muscle injections. Patients in the placebo group will receive injections with an inactive placebo, visually indistinguishable from ADRCs. You will have a 67% chance of receiving ADRCs and a 33% chance of receiving placebo. Remember, this is a double-blind study and so the study doctor, the study staff and you will not know what investigational treatment you will receive.

The entire procedure from the start of the liposuction through to completion of the heart injections will take approximately eight (8) hours and you will then remain in the hospital overnight for observation. Follow-up visits occur at one (1) week and at one (1), three (3), six (6), and twelve (12) months after the procedure. You will also have follow up telephone calls from study staff two (2), three (3), four (4), and five (5) years after the procedure. In addition, the study doctor and study staff will always be available to you if you have questions or concerns.

Are there any risks with being in the ATHENA clinical trial?

The investigational ADRC Therapy being studied in the ATHENA clinical trial has not been sufficiently evaluated to determine whether the therapy provides true benefits. The information gathered during the ATHENA trial will give doctors and scientists a better idea about whether there might be a benefit.

There are both known and unknown risks associated with the liposuction procedure, the investigational catheter-based procedure that will be used to inject your ADRCs into your heart, and the use of investigational ADRC Therapy. If you are or someone you know is interested in participating in the ATHENA clinical trial, the study doctor and study staff will review the clinical trial details with you including all of the risks. You can then make an informed decision as to whether you are still interested in participating in the clinical trial. The study doctor will then determine if you are eligible.