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Principal Investigator: Dr. Rory Todhunter

Contact Information: Email: rjt2@cornell.edu - Phone: 3-3249
Sponsor: Harvest Technologies
Title: Validation and Trial Implantation of Bone Graft Substitute in Dogs
Annual Direct Cost: $23,745
Project Period: 7/1/04-6/30/05

Approximately 600,000 bone graft procedures were performed in the United States in 2003. These occurred in orthopedic, trauma reconstructive and oral maxillofacial surgeries. Of this number, surgeons engaged in 400,000 secondary surgical procedures to harvest autograft bone. Autograft is preferred as an immediate source of osteoprogenitor cells that promote new bone formation and timely graft incorporation and has reported fusion rates of 90%.  Autograft also has the added value of being inherently non-immunologic and histocompatible when compared to synthetic or allogeneic graft materials. However, while autograft is considered the gold standard for bone fusion, it can not be used in all cases.  In addition to its limited supply in elderly and pediatric patients, reharvest for subsequent grafting requirements is problematic. Also, the harvest itself has been documented to have serious morbidities, such as increased recovery time and disability and even 20% of patients reporting pain up to 24 months post surgery.  A quick, simple, safe and inexpensive alternative to this surgical harvest that would still achieve similar quality of bone formation would be valuable to both patients and clinicians. Should such an alternative also demonstrate faster bone formation, it would represent an important advancement. Such an alternative could be used in place of autograft harvest procedures, but it could offer an effective modality for all bone graft procedures.

This pilot study will evaluate point-of-care device methodologies that may prepare a concentration of stem cells from a small volume of bone marrow blood and prepare autologous thrombin and autologous platelet concentrate from a small volume of peripheral blood.  Concentrated stem cells from the bone marrow coupled with proteins present in various blood components have been shown to offer the potential to form bone and thereby replace autograft.