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FDA Gives OK for Use of Durham Firm's Technology in Stem Cell Trial

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DURHAM, NC — Texas doctors will utilize stem cell technology from Durham-based


as part of an effort to help advanced heart failure patients.

Aldagen, which recently changed its name from StemCo, received Food and Drug Administration approval for the trial that will initially involve 10 patients.

The doctors will use stem cells harvested from patients' bone marrow using Aldagen's Aldesort technology.

"These stem cells have the potential to build new blood vessels (angiogenesis) in damaged hearts which could ultimately lead to improved functional improvement in advanced heart failure patients," Aldagen said in a statement.

Several companies around the world offer therapy in which stem cells are injected directly into the heart, according to a


from The Associated Press. The AP said several teams are exploring similar methods in the United States.

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."

Emerson Perin and James Willerson, doctors at the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston will lead the study. The center is one of the nation's top 10 heart centers in surveys published by U.S.News & World Report

"We believe these cells have the potential to find a very important place in the future treatment of patients with heart and vascular disease," the doctors said in a joint statement.

Willerson is medical director of the Texas Heart Institute and president of The University of Texas Health Sciences Center at Houston. Perin is director of New Cardiovascular Interventional Technology and director of the Stem Cell Center at the institute.

The two have already been involved in treatments of heart patients with unfractionated, or not separated, bone marrow cells. A catheter is used to inject the cells into areas of the heart that the doctors have identified as having been damaged.

In the trial, Aldesort technology will be used to retrieve what Aldagen describes as "highly potent" stem cells for use in the procedure developed by Willerson and Perin.

"These cells are more active in restoring blood flow to damaged tissue than unfractionated bone marrow in pre-clinical animal models," Aldagen said.

The first 10 patients will be tested primarily to determine the safety of the procedure. In all, some 60 patients will be involved with half receiving stem cells as isolated by Aldesort, according to the company.

"We are delighted to be working with a leading institute like the Texas Heart Institute at St. Luke's for our first cardiovascular stem cell therapy trial," said Ed Field, president and chief executive officer of Aldagen. "We look forward to initiating the trial and determining whether the injection of Aldesort isolated stem cells can improve the health of heart failure patients."

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