Available NIH and FDA approved clinical trial at five centers nationwide for patients with congestive heart failure.

What? Phase II clinical trial evaluating effects of Autologous Bone Marrow Mononuclear Cells for Patients with Chronic Ischemic Heart Disease and Left Ventricular Dysfunction (FOCUS)

Where? Participants receive care at these locations:

• Cleveland Clinic, Cleveland, Ohio
• Minneapolis Heart Institute, Minneapolis, Minnesota
• Texas Heart Institute, Houston, Texas
• University of Florida, Gainesville, Florida
• Vanderbilt University, Nashville Tennessee

Why? To evaluate safety and effectiveness of using a patient’s own stem cells (autologous) to stimulate new heart muscle and blood vessel growth in the failing heart.

How? Under anesthesia, a bone marrow sample is taken from the patient’s hip bone. Adult stem cells, which have been selected from the bone marrow, are injected into the patient’s heart using a guidance system to place cells directly in the patient’s damaged heart muscle. The patient will be followed to assess how their heart responds.

When? This 6-month study will begin accepting patients in January 2009.  Patients are required to travel to one of the cities listed above for the procedure and for follow-up evaluation over the 6 months following recruitment.

Who may participate? Patients must meet the following criteria:

• Must be at least 18 years of age
• Must have depressed heart function
• Must be using appropriate medications for their heart failure
• Must be in danger of losing more heart muscle due to their disease

Who may not participate? Patients may not participate if they meet the following criteria:

• Dangerous heart rhythm
• Had a procedure to increase blood flow in their heart’s arteries within thirty days of enrollment
• Have a history of severe anemia, liver disease, or other chronic disease
• Unable to provide informed consent
• Women of child bearing potential not willing to practice an active form of birth control

For more information:

Dr. Lemuel A. Moyé
University of Texas School of Public Health
RAS Building
1200 Herman Pressler
Houston, Texas, 77030
E-mail:  This e-mail address is being protected from spambots. You need JavaScript enabled to view it