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OCG-I Autologous Bone Marrow for the Treatment of Appendicular Skeletal Fracture Non-Union

This trial will study a group of patients with severe appendicular skeletal fractures who require bone grafting to achieve satisfactory healing. This natural healing process will be augmented with large numbers of bone forming cells produced from a small volume autologous marrow aspirate. The hypothesis of the study is that TRC autologous bone marrow cells, produced ex-vivo in the AastromReplicell System, function similarly to autograft (harvested bone and bone marrow). The study will also demonstrate that a simple and rapid outpatient percutaneous bone marrow collection procedure can replace the entirety of a full harvest performed by chiseling bone and marrow from the iliac crest under general anesthesia. Patients eligible for the trial will have identified appendicular skeletal fracture atrophic non-unions or have an open fracture with a substantial likelihood of non-union without autologous bone grafting.