Tissue Repair Cells Treat Fractures

A feasibility clinical trial has shown that all of the patients with severe, long-bone non-union fractures who were treated with tissue repair cells (TRCs) experienced healing, with five of six treatments showing bone regeneration at the fracture site by six months.

The TRCs, developed by Aastrom Biosciences (Ann Arbor, MI, USA), are a proprietary mixture of bone marrow-derived adult stem and progenitor cells produced using Aastrom's patented single-pass perfusion technology in the AastromReplicell system. The trial was conducted with the Institut de Terapia Regenerativa Tisular (ITRT) in Barcelona (Spain). The results were notable in that each patient had failed prior treatment with standard-of-care methodologies and had a poor prognosis for healing.

All the five patients in the trial (one received treatment for two fractures) had first undergone open surgery to apply a metal plate internal fixation to replace previous failed fixation. The TRCs were then mixed with synthetic commercial matrix and an autologous fibrin and applied directly to the fracture site, to aid local bone regeneration. No complications or adverse effects were observed.

To date, two of the patients have been evaluated for more than one year after surgery, and a third patient has been monitored for more than eight months. All patients can bear weight on the treated fractured bone, have had their range of motion in the limb restored, and are free from pain. The inflammation and edema that are characteristic of typical bone grafting in fracture-healing procedures were either reduced or were absent at the surgical site postoperatively in all patients.

"As the physician treating these patients, I am extremely encouraged by our first use of TRCs, and believe that they may represent a new tool in orthopedic medicine,” said Carlos Solano-Puerta, M.D., principal clinical investigator for the Barcelona trial.

Aastrom is now preparing to expand this long-bone fracture trial in Barcelona, to implement several refinements in the procedure intended to further improve the use of TRCs in bone grafting.




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