Aldagen IND for Stem Cell Clinical Trial to Treat Critical Limb Ischemia Is Cleared By FDA.

DURHAM, N.C. -- Aldagen, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to conduct a clinical trial using Aldagen's ALDESORT product to isolate a unique stem cell population for therapy for critical limb ischemia patients. It will be the first clinical trial involving this unique cell population for therapy for critical limb ischemia patients in the United States.

Critical limb ischemia (CLI) is a severe form of peripheral vascular disease (PVD). It is estimated that between eight 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. CLI can lead to gangrene or tissue death, often necessitating amputation of the affected limb. Currently, 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 and 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.

Aldagen's clinical trial will involve 20 patients, all of which will have bone marrow extracted. Ten patients will receive multiple injections of the bone marrow directly into muscle in the ischemic leg and ten patients will receive multiple injections of stem cells isolated from the bone marrow using Aldagen's ALDESORT product. The patients will be monitored for up to six months with a primary endpoint at three months. Endpoints will include safety and the ability of therapy to reduce rest pain, increase exercise capacity, increase skin surface oxygen pressure and improve ulcer healing. Aldagen is finalizing the clinical trial sites for the study.

"It is important for us to show that the injection of stem cells from the patient's bone marrow isolated using ALDESORT will outperform unfractionated bone marrow, said Dr. Becky Haley, Aldagen's Vice President of Clinical and Regulatory Affairs. "Unfractionated bone marrow has been used by several international clinical groups for the treatment of CLI and has shown modest clinical benefit. ALDESORT-isolated cells are more active in restoring blood flow to damaged tissue than unfractionated bone marrow in pre-clinical animal models."

ALDESORT isolates a highly potent population of stem cells taken from the patient's own bone marrow. These stem cells have the potential to build new blood vessels (angiogenesis) in ischemic legs which could ultimately lead to improved functional improvement in critical limb ischemia patients.

"This announcement represents the third IND that has been cleared by the FDA within the last twelve months for the use of ALDESORT in a clinical trial," said Tom Amick, Chairman and CEO of Aldagen. "We believe this is an unparalleled accomplishment in the stem cell therapy space. We look forward to initiating the trial and determining whether the injection of ALDESORT isolated stem cells can improve the health of critical limb ischemia patients."

About Aldagen, Inc.

Aldagen's proprietary products identify and isolate unique populations of adult stem cells with the potential to revolutionize treatments of cardiovascular disease and degenerative diseases. The Company is testing its ALDESORT product in a clinical trial at Texas Heart Institute to treat ischemic heart failure patients in addition to a cord blood transplantation study at Duke University Medical Center. To learn more about Aldagen's products for preparing optimal cell populations for adult stem cell therapy, the Company invites you to visit its website at www.aldagen.com.