ALD-301 is a potent population of stem and progenitor cells isolated from patient’s bone marrow using Aldagen’s proprietary technology.  ALD-301 is being used in clinical trials to treat patients with critical limb ischemia (CLI).  ALD-301 is administered via intramuscular injections into the lower half of the leg of CLI patients.  ALD-301 contains a mix of all of the stem and progenitor cell types needed for CLI therapy including both endothelial, mesenchymal and neural progenitors.  In preclinical testing, ALD-301 has been shown to repair ischemic damage and to significantly out-perform the unfractionated adult bone marrow preparation that is currently being used in clinical trials to treat severe peripheral vascular disease.

About Critical Limb Ischemia

Critical limb ischemia (CLI) is the severe form of peripheral vascular disease (PVD). It is estimated between 8 to 12 million Americans suffer from PVD, which is a disease of the blood vessels characterized by narrowing and hardening of the arteries that supply the legs and feet. This causes a decrease in blood flow that can injure nerves and other tissues. Critical limb ischemia, can lead to gangrene or tissue death, often necessitating amputation of the effected limb. In 1996, an estimated 128,588 individuals lost a limb because of CLI. There are no suitable alternatives to either percutaneous or surgical revascularization in patients with CLI. Despite some success of limb salvage with leg bypass, the condition remains associated with a substantial rate of morbidity and mortality. The need for subsequent surgery and hospitalization for wound complications is as high as 50%. There is a pressing need for the development of techniques to improve the vascular supply to ischemic leg by less invasive means.  Successful clinical outcomes with ALD-301 would offer a non-surgical intervention to improve circulation for patients in need of escalated medical intervention.