A multi-center, randomized, clinical study to compare the effect and safety of autologous cultured osteoblast(Ossron) injection to treat fractures

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Authors: Seok-Jung Kim ; Yong-Woon Shin ; Kyu-Hyun Yang ; Sang-Bum Kim ; Moon-Jib Yoo ; Suk-Ku Han ; Soo-Ah Im ; Yoo-Dong Won ; Yerl-Bo Sung ; Taek-Soo Jeon ; Cheong-Ho Chang ; Jae-Deog Jang ; Sae-Bom Lee ; Hyun- Cho Kim ; Soo-Young Lee

MeSH: Adolescent ; Adult ; Aged ; Alkaline Phosphatase/metabolism ; Bone Marrow Cells/cytology ; Bony Callus*/metabolism ; Bony Callus*/pathology ; Cell Culture Techniques ; Cell Transplantation ; Cells, Cultured ; Collagen Type I/metabolism ; Female ; Fracture Healing* ; Fractures, Bone/metabolism ; Fractures, Bone/pathology ; Fractures, Bone/surgery* ; Humans ; Male ; Middle Aged ; Osteoblasts/cytology ; Osteoblasts/metabolism ; Osteoblasts/transplantation* ; Transplantation, Autologous ; Treatment Outcome ; Young Adult

Abstract: BACKGROUND: We performed a multicenter, open, randomized, clinical study of autologous cultured osteoblast injection for long-bone fracture, to evaluate the fracture healing acceleration effect and the safety of autologous cultured osteoblasts.

METHODS: Sixty-four patients with long-bone fractures were randomly divided into two groups, i.e. those who received autologous cultured osteoblast injection and those who received no treatment. The sum of the difference in the callus formation scores after four and eight weeks, was used as the first efficacy variable.

RESULTS: The autologous cultured osteoblast injection group showed fracture healing acceleration of statistical significance, and there were no specific patient complications when using this treatment.

CONCLUSION: Autologous cultured osteoblast injection should therefore be considered as a successful treatment option for treating long-bone fracture.