Cardiovascular Regenerative Medicine

Vascular Disease (Peripheral Artery Disease/Severe Intermittent Claudication)

Peripheral arterial disease (PAD) occurs when arteries in the hands, legs, and feet are narrowed or blocked by atherosclerosis, decreasing the blood and oxygen supply to the muscles of the extremities.  An insufficient blood and oxygen supply to the leg muscles results in fatigue, discomfort or pain defined as claudication.  Claudication can be intermittent in nature meaning the pain and discomfort usually goes away with rest.  Intermittent claudication may occur in one or both legs and often continues to worsen over time. For some individuals, claudication is labeled “severe” in that the pain does not go away with rest.

Douglas W. Losordo, MD is the Director of the Program in Cardiovascular Regenerative Medicine.  Regenerative medicine is a rapidly developing field of medicine that seeks to develop methods to regenerate (repair) and replenish (replace) damaged tissue in the body.

It is through Dr. Losordo's years of experience and research that the following clinical research trial is being offered to patients with severe intermittent claudication, with the goal of improving blood flow to the legs:

Injection of Autologous CD34-Positive Stem Cells for Neovascularization and Symptom Relief in Patients With Severe Intermittent Claudication

The goal of this study is to look at the safety of different doses (or amounts) of autologous (one’s own) stem cells given with a needle into the parts of the leg with poor blood flow.  Stem cells are cells made by bone marrow that can develop into blood cells or become another type of cell with a more specialized function, such as a muscle cell.

This is a Phase I study set up to look at the safety and possible effectiveness of injecting a patient’s own stem cells in the regions of the leg with poor blood flow.  A Phase I study is the first use of a new drug (in this case, cell therapy) in humans.  In a Phase I study the new cell therapy is tested by increasing the number of stem cells given in small groups of people.  The effects of the stem cell injection will be compared to placebo in terms of decreasing pain and increasing ability to walk as well as evaluating safety of the stem cell injections.

This clinical research trial is being conducted at 3 different institutions in the United States.  Dr. Losordo is responsible for this trial on a national level (national principal investigator) and at Northwestern Memorial Hospital (local principal investigator).  Additional co-investigators on this study at Northwestern include Nirat Beohar, MD, Richard K. Burt, MD, Melina R. Kibbe, MD, and William H. Pearce, MD.

More information about this clinical trial can be found at ClinicalTrials.gov.

Contact

If you wish to obtain more information about this clinical research trial and for more information regarding Cardiovascular Regenerative Medicine, please contact the Program in Cardiovascular Regenerative Medicine at (312) 695-0072.