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Embargoed for release until 12:01 a.m. E.T. Wednesday, March 4, 2009
Donor Stem Cells Successfully Heal Bone in Foot, Ankle: Study Patients Had Failed Prior Surgeries
Washington, D.C. [March 4, 2009] – In the first study of its kind, the use of donor stem cells was shown to be safe and successful in healing bone in patients who had failed previous surgeries and were at high risk for non-healing, according to information to be presented this week at the 67th Annual Scientific Conference of the American College of Foot and Ankle Surgeons (ACFAS) and published in the March issue of the College’s Journal of Foot & Ankle Surgery.
Stem cells are primitive cells found in blood and bone marrow that can differentiate into many different types of human tissue. Osteoprogenitor stem cells – those that have differentiated into bone-producing cells – were used in the surgeries. The stem cells were harvested from the bones of cadavers.
The study involved 23 patients who had failed previous surgeries. Many had risk factors that contribute to non-healing, such as diabetes or renal disease, which put them at high risk for not healing again, according to Shannon M. Rush, DPM, FACFAS, Department of Orthopedics and Podiatric Surgery, The Palo Alto Medical Foundation, Mountain View, Calif., and principal author of the study.
Of the 23 patients treated with the new technology – called mesenchymal stem cell (MSC) bone allograft – 21 (90.3 percent) achieved bone union and healing. Clinically, healing was defined as patients being able to walk with no or little pain in regular shoes at least six months after their casts were removed.
The researchers followed the patients with X-ray examinations for up to 12 months to confirm that the bones had healed. There was no evidence of rejection of the donor tissue and no complications associated with its implantation were reported.
A significant advantage of this technique is that it uses donor stem cells, rather than bone donated by the patient, which would require an additional surgical site with potential complications, according to co-author Graham A. Hamilton, DPM, FACFAS, Department of Orthopedics and Podiatric Surgery, Kaiser Permanente Medical Center, Antioch, Calif.
Among factors that put patients at high risk for non-healing are diabetes, neuropathy (nerve damage), older age, osteopenia (bone loss associated with conditions such as osteoporosis), smoking, trauma, bone loss associated with poor blood circulation, and multiple surgeries.
Conditions that may be especially appropriate for treatment with MSC include Charcot neuroarthropathy – a bone disease that occurs as a complication of diabetes – and trauma to the lower extremity of the tibia, the leg bone that forms the ankle. Other broken bones that have not healed after previous surgeries also may be an indication for the procedure.
MSC is a proprietary technology (Trinity® Multipotential Cellular Bone Matrix, Orthofix, Inc., Verona, Italy). The authors stated there were no financial or other ties between Orthofix and the study presented at the ACFAS meeting.
About ACFAS
The American College of Foot and Ankle Surgeons is a professional society of more than 6,000 foot and ankle surgeons. Founded in 1942, the College’s mission is to promote research and provide continuing education for the foot and ankle surgical specialty, and to educate the general public on foot health and conditions of the foot and ankle through its consumer Web site, FootHealthFacts.org.