Aastrom’s Stem Cells Knit Hard-to-Heal Bone Breaks (Update1)
By Rob Waters
Oct. 18 (Bloomberg) — Aastrom Biosciences Inc. said its stem cell treatment repaired fractures in 91 percent of patients with previously hard-to-heal breaks in the long bones of their thighs, shins or arms.
The study tested stem cells developed by Aastrom by inserting them during surgery into the fracture sites of 33 patients with severe bone breaks that had previously failed to join from standard treatments. A year later, the fractures of 30 of the patients had healed, the Ann Arbor, Michigan-based company reported today at a medical meeting in Boston.
“We are treating patients that have not healed in the past and are unlikely to heal in the future with normal procedures,” said Elmar Burchardt, the company’s vice president of medical affairs, in a telephone interview. “It’s a completely new approach for bone treatment and tissue regeneration with the idea of restoring its original architecture.”
Aastrom, one of several U.S. companies working to bring stem cell-based treatments to market, has created a technique for expanding and purifying patients’ own stem cells as a therapy. The company is testing its approach in several orthopedic uses as well as in a disease that restricts blood circulation in limbs. It’s also developing treatments for patients with heart disease and spinal cord injuries.
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The company is furthest along in testing its cells to treat a rare condition called osteonecrosis that damages bone in the hips and other places because of a poor blood supply. The company is now recruiting 120 osteonecrosis patients for the final stage of testing normally required for regulatory approval. It could seek clearance from the U.S. Food and drug Administration as early as 2010, Burchardt said.
Aastrom rose 4 cents to $1.20 at 6:02 p.m. New York time in extended trading. The stock gained 2 cents to $1.16 at 4:20 p.m. in regular Nasdaq Stock Market composite trading.
The 30 bone-fracture patients who were deemed by the company to have healed all had bone scans that showed “multiple contact points” between pieces of bone that were formerly fragmented, Burchardt said. The patients’ limbs now “are fully weight- bearing and have full range of motion,” he said.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .