Doctors in the U.S. are currently enrolling patients in a new research study. The purpose of the study is
to evaluate an investigational treatment for Critical Limb Ischemia. The investigational treatment involves removing stem cells from your own bone marrow and injecting them into your leg to possibly improve
blood flow.

Investigational Treatment Overview

If, after being evaluated, you are offered enrolment in the research study and you agree to participate, you will be scheduled for the study procedure. This procedure is performed in an operating room using local anesthesia and sedation. A doctor will draw a small amount of blood from your IV and will place a needle into each hip bone to collect bone marrow aspirate (BMA), a fluid that resembles blood. This fluid will be withdrawn into a syringe and then processed in a special centrifuge system that separates and concentrates certain cells in 15 minutes. Following this, your doctor will use a thin needle to inject processed blood or BMA near the blocked blood vessels of your leg, as well as around any areas of ulcers or gangrene (if present).

Study Details

If you choose to take part in this study, you may or may not receive the investigational stem cell treatment.
As part of the study, 2 out of every 3 patients will receive the investigational treatment, while 1 out of every
3 patients will receive a simulated treatment (also called a “control” treatment). Patients receiving the control treatment will not be injected with their own stem cells; rather, these patients will be injected with their own diluted blood. This blood injection is not believed to result in improved circulation. The decision as to which treatment you will undergo (investigational or control) is made at random (like flipping a coin). You will have
a 2 in 3 chance of receiving the investigational treatment. However, regardless of which treatment you undergo, neither you nor your study doctor will know which treatment you received.

Study Locations

This study is being conducted at several specialized centers throughout the U.S. The stem cell treatment being offered through this study is investigational (which means it has not yet been approved for general use by the FDA); as such, this treatment is only available to patients taking part in the study.

• Tufts Medical Center, Boston, MA
• Roper St. Francis, Charleston, SC
• Methodist Hospital, Houston, TX
• University of South Florida Health, Tampa, FL
• Vascular Associates of Albany, Albany, NY