Aastrom begins phase 1/2 study of Tissue Repair Cells for bone fractures

By Angela McDaniels

Seattle, Dec. 13 - Aastrom Biosciences Inc. said it has begun a phase 1/2 clinical trial of the company's Tissue Repair Cells for the repair of long bone fractures.

The trial is designed to further demonstrate the safety of the Tissue Repair Cells and their effectiveness in regenerating new, healthy bone.

This study follows a successful five-patient pilot trial and will incorporate various procedure refinements meant to provide more uniform use of the Tissue Repair Cell procedure at different clinical sites, the company said.

"This trial is significant on several levels," chief executive officer and chairman R. Douglas Armstrong said in a company news release.

"On a regulatory level, the approval we have received from the Spanish Drug Agency indicates that we have met the new stringent requirements that have been set in place by the recent adoption of the new clinical trial directive in the European Union for cell product clinical trials.

"In addition, our ability to further refine our clinical protocol regarding the methodology of our Tissue Repair Cell treatment constitutes further progress and resolution in our product development program."

The new trial will enroll a maximum of 10 patients who will be treated for non-hypertrophic pseudoarthrosis of long bones, or failure of a fracture to heal properly. After treatment, patients will be monitored over 24 months for callus and bridge formation at the fracture site.

The trial will be held at the Hospital de Barcelona, Hospital General de l'Hospitalet and Centro Medico Teknon in Barcelona and is sponsored by Fundacion Teknon and Institut de Terapia Regenerativa Tisular, the company said.

Tissue Repair Cells are Aastrom's proprietary mixture of bone marrow-derived adult stem and progenitor cells. A small sample of bone marrow is collected from the patient's hip. Tissue Repair Cells are then produced in the company's automated AastromReplicell System over a 12-day period.

Aastrom said Tissue Repair Cells are able to develop into different types of tissue lineages in response to inductive signals, including blood, bone, bone marrow, cartilage, adipose and vascular tubules.

Aastrom is an Ann Arbor, Mich.-based company that develops patient-specific products for the repair or regeneration of human tissues using the company's adult stem cell technology.

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