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Stem Cell Firm Aldagen Receives FDA Approval for Clinical Trial

Posted April 13, 2006

— The Food and Drug Administration has granted its approval of a clinical trial for a potential treatment of hardening or narrowing of arteries in the legs of feet developed by

Aldagen

.

The Durham-based company is developing therapies based on stem cell research. The firm, which recently changed its name from Stemco, has now received FDA approval for three clinical trials.

According to the National Institutes of Health, stem cells have the "remarkable potential" to develop into many different cell types and serve as a "sort of repair system for the body". "(T)hey can theoretically divide without limit to replenish other cells as long as the person or animal is still alive," according to the NIH. "When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell."

The leg and feet ailment is known as limb ischemia, a critical form of peripheral vascular disease that affects millions of Americans. It often leads to the need for amputation.

Aldagen's technology is known as Aldesort.

"This announcement represents the third (investigational new drug) that has been cleared by the FDA within the last 12 months for the use of Aldesort in a clinical trial," said Tom Amick, chairman and chief executive officer 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."

Aldagen has developed technology that enables the isolation of what it calls "highly potent population" of stem cells from each patient's own bone marrow.

"These stem cells have the potential to build new blood vessels in ischemic legs which could ultimately lead to improved functional improvement in critical limb ischemia patients," the company said.

The Aldesort-isolated stem cells from bone marrow will be injected into 10 patients in the trial. Ten others will receive unfractionated, or not separated, bone marrow that has not gone through the Aldesort process.

"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 Becky Haley, vice president of clinical and regulatory affairs at Aldagen. "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."

In February, Aldagen received approval for a trial involving a potential treatment for advanced heart failure. The other trial involves cord blood transplantation.

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