Aastrom Will Test Stem Cells in Patients With Diseased Limbs
By Rob Waters
April 30 (Bloomberg) — Aastrom Biosciences Inc. will begin a clinical study using people’s own stem cells to improve the poor blood circulation that has damaged their legs, a condition known as critical limb ischemia.
U.S. regulators have given the company permission to begin trials, based on results from a small pilot study in Germany that suggested the treatment was safe, said Elmar Burchardt, vice president of medical affairs at the Ann Arbor, Michigan, company.
About 900,000 Americans suffer from limb ischemia, which can impair the body’s ability to heal wounds and leads to 100,000 amputations each year, according to the U.S. Centers for Disease Control and Prevention. The condition is the most serious form of peripheral artery disease, which occurs when blocked arteries impede the flow of blood to the legs. It affects about 10 million people in the U.S.
“These are critically ill patients,” said Burchardt, in a phone interview. “Their wounds are not closing and they have a very high risk of having to undergo an amputation.”
The trial will include 120 patients at 20 centers around the U.S. Doctors will take bone marrow cells from the patient’s hips and send them to Aastrom, which will process them to increase the number of stem cells while keeping them from turning into other cell types.
Bone marrow is one of the places in the body where so- called adult stem cells are found. These cells have the ability to turn into cartilage, bone and blood and are part of the body’s own system for repairing injury and disease.
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In half the patients, the amplified cells will then be injected at multiple points in their legs, above and below the knee. The other patients will go through the same procedure but won’t get real stem cells.
“The idea is you cover a large area with injections, stimulate vessel growth and improve blood flow in the limb,” Burchardt said.
Eight patients went through this procedure in the German study, Burchardt said. About half have passed the one-year mark, and all of those showed signs that their wounds were healing. None of the eight patients experienced any adverse effects, he said.
If successful, results from the larger U.S. study “may apply to all ischemic diseases,” said Anthony Comerota, director of the Jobst Vascular Center in Toledo, Ohio, in a statement e-mailed by Aastrom. He is the study’s lead investigator.
The study could thus help validate the idea of using stem cells to treat heart disease. The first results from the new study won’t be available until patients have been treated for a year.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .
Last Updated: April 30, 2007 07:01 EDT