Stem Cell Technology Heals Broken Bones

Researchers of the Illinois Bone & Joint Institute (Chicago, USA) conducted a multi-center, prospective, open-label Phase I/II clinical study of 36 eligible patients with severe long bone non-union fractures of the tibia, humerus, or femur, that had failed to heal with one or more (average of 1.75) prior medical procedures. The patients underwent a standard open reduction and internal fixation surgery in which bone repair cells (BRCs) were applied directly to the fracture site, together with an allograft bone matrix, to promote local bone regeneration. Of these patients, 33 patients were followed for 12 months. Three patients failed to complete the required follow-up visit. Healing was determined by bone bridging observed with radiographic imaging or computed tomography (CT).

Final results showed healing success in 91% (21 of 23) of tibia fractures, 100% (3 of 3) of humerus fractures, and 86% (6 of 7) of femur fractures. In addition to the 91% healing rate observed after 12 months, results at six months showed that bone bridging successfully occurred in 85% of patients and that signs of early healing (callus formation) were present in 97% of patients. No cell-related adverse events were reported. The study was presented at Orthopaedic Trauma Association annual meeting, held in Boston (MA, USA), during October 2007.

"The results suggest that BRCs are efficacious for the treatment of recalcitrant long bone non-union fractures,” said lead author Matthew L. Jimenez, M.D. "BRCs have the potential to become a powerful new tool for bone regeneration and to improve the management of severe fractures.”

BRCs are derived from a small sample of the patient's bone marrow that is processed using tissue repair cell (TRC) technology developed by Aastrom Biosciences (Ann Arbor, MI, USA) to generate larger numbers of stem and early progenitor cells with enhanced therapeutic potential.


Related Links:
Illinois Bone & Joint Institute
Aastrom Biosciences