THE PROCEDURE

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

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

Illustration
  1. At the start of the procedure, all trial participants (including those who will receive placebo) will undergo a fat collection procedure (liposuction) to remove approximately 1-2 cups of their fat tissue. This procedure will be conducted under local anesthesia (medicines that reduce pain) with or without conscious sedation (medications to make you sleepy). The choice of which medicines are used 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 (approximately 3 hours) you will be resting.
  3. After preparation of your ADRCs is complete, the appropriate study treatment (your ADRCs or placebo) will be injected into your fingers with a small needle.
    1. First, you will receive medication to reduce discomfort from the procedure. Then the study treatment will be injected.
    2. Patients in the placebo group will receive injections with an inactive placebo, visually the same as the ADRCs. You will have a 50% chance of receiving ADRCs and a 50% 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. However, if you receive placebo and continue to qualify for treatment, you can receive treatment with your own ADRCs at the end of the trial.

The entire procedure from the start of the liposuction through to completion of the finger injections will take approximately six (6) hours and you will then be able to return home the same day. Follow-up visits occur at one (1), four (4), eight (8), twelve (12), twenty-four (24), thirty-six (36), and forty-eight (48) weeks 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 STAR clinical trial?

The investigational Celution® prepared ADRCs being studied in the STAR clinical trial have not been studied enough in the US to know for certain whether the treatment provides benefits to patients with impaired hand function due to scleroderma. The information gathered during the STAR trial will give doctors and scientists a better idea about the benefit of ADRC treatment.

There are both known and unknown risks associated with the liposuction procedure, the finger injection procedure, and the use of investigational Celution prepared ADRCs. If you (or someone you know is) are interested in participating in the STAR 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.