Difficult to Heal Fractures Get Enormous Healing Boost from Stem Cells

The China Post, October 20, 2007

Patients with previously hard-to-heal breaks in the long bones of their thighs, shins or arms, achieved repair in 91 percent of fracture cases due to stem cell therapy stated Aastrom Biosciences Inc.

33 patients with severe bone breaks that had previously failed to join from standard treatments had stem cells surgically inserted at their fracture sites in a study using stem cells developed by Aastrom. Today at a medical meeting in Boston, the Ann Arbor, Michigan-based company reported that the fractures of 30 patients had healed a year following stem cell therapy.

"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 has created a technique for expanding and purifying patients' own stem cells as a therapy, and is one of several U.S. companies working to bring stem cell-based treatments to market.

Establishing efficacy in a disease that restricts blood circulation in limbs is also part of company tests in addition to testing its approach in several orthopedic uses. Spinal cord injuries and heart disease treatment development is also in the works.

Due to a poor blood supply, osteonecrosis is a condition that damages bone in the hips and other areas. The company is furthest along in testing its cells to treat this rare condition. The company has entered the final stage towards regulatory approval. They have recruited 120 osteonecrosis patients for a last phase study. Burchardt said that as soon as 2010, clearance from the U.S. Food and drug Administration could be sought.

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.