Cardiovascular Regenerative Medicine

Vascular Disease (Critical Limb Ischemia)

Peripheral arterial disease (PAD) occurs when arteries in the hands, legs, and feet are narrowed or blocked by atherosclerosis, decreasing the blood supply to the hands, legs and feet. Critical limb ischemia (CLI), a very severe condition of PAD, is manifested by pain at rest, non-healing wounds, and gangrene.  It is estimated that 750,000 people suffer from the disease in the United States, resulting in 100,000 amputees per year. Critical limb ischemia is a persistent and relentless problem that severely impairs the patient’s ability to function independently and without pain.

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 moderate to high risk critical limb ischemia (pain at rest and/or non-healing wounds) to improve blood flow to the legs:

Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects with Moderate or High-Risk Critical Limb Ischemia

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 phase I/IIa clinical research trial has been set up to evaluate the safety and possible effectiveness of injecting a patient’s own stem cells in the regions of the leg with poor blood flow. The ultimate goal is to find a therapy that will alleviate pain and prevent limb loss. A phase I study is the first use of a new drug (in this case, cell therapy) in humans.  In this phase I study, two different doses (or amounts) of stem cells in two separate groups of trial subjects will be studied.  The effects of the stem cell injection will be compared to a third placebo group.

This clinical research trial is being conducted at 20 different institutions in the United States.  Dr. Losordo is responsible for this trial on a national level (national principal investigator) and Melina R. Kibbe, MD is responsible for this trial at Northwestern Memorial Hospital (local principal investigator).  Dr. Kibbe is a vascular surgeon at the Bluhm Cardiovascular Institute of Northwestern Memorial Hospital, and assistant professor, Northwestern University’s Feinberg School of Medicine.  Additional co-investigators on this study include Nirat Beohar, MD, Richard K. Burt, 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.