CLI occurs when the body’s repair systems can no longer compensate for the severely blocked arteries.
Critical limb ischemia (CLI) is a severe blockage in the arteries of the lower extremities, which markedly reduces blood-flow. It is a serious form of peripheral arterial disease, or PAD. PAD is caused by atherosclerosis, the hardening and narrowing of the arteries over time due to the buildup of fatty deposits called plaque.
CLI is a chronic condition that results in severe pain in the feet or toes, even while resting. Complications of poor circulation can include sores and wounds that won't heal in the legs and feet. Left untreated, the complications of CLI will result in amputation of the affected limb.
Research has already been conducted in various forms on removing stem cells from a patient’s own bone marrow and using them to repair damaged tissue. This research suggest that a patient’s own stem cells may be used to help the natural healing process. More studies are needed before these treatments have been refined to prove they work consistently, which is why this clinical study is being conducted.
New study of an investigational treatment for patients with PAD and non-healing wounds using adult stem cells.
Adult stem cells are undifferentiated cells, found throughout the body after development, that multiply by cell division to replenish dying cells and regenerate damaged tissues. Also known as somatic stem cells. Adult stem cells have the ability to divide or self-renew indefinitely, and generate all the cell types of the organ from which they originate, potentially regenerating the entire organ from a few cells. Unlike embryonic stem cells, the use of adult stem cells in research and therapy is not considered to be controversial, as they are derived from adult tissue samples rather than destroyed human embryos.
Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as damaged cells in tissues.
Stem cells are distinguished from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue-specific cells with special functions. In some organs, such as the gut and bone marrow, stem cells regularly divide to repair and replace worn out or damaged tissues.
We are currently enrolling patients in a clinical study of an investigational treatment for patients with PAD and non-healing wounds. If you suffer from Critical Limb Ischemia and have been told you are no longer a candidate for surgical or interventional options for revascularization and no response to optimal medical care as confirmed by a vascular surgeon and/or physician, you may be a candidate for a research study of an investigational treatment.