As we age, plaque can build up in the blood vessels of the legs. This causes the arteries to narrow, which reduces blood flow and may lead to pain or weakness in the legs and/or feet. As this condition progresses, blood flow to the legs and feet can become severely reduced sometimes causing advanced Peripheral Arterial Disease (PAD), also called Critical Limb Ischemia (CLI).
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function.
This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores, ulcers, gangrene, and even amputation. Fortunately, current medical and surgical procedures can improve the blood flow in many patients using bypass operations, stents, or other techniques.
The bad news is that these techniques have their limits and many people suffering from limb ischemia are not candidates for conventional treatments.
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.