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


CONCLUSIONS
Autologous cultured osteoblast injection should therefore be considered as a successful treatment option for treating long-bone fracture.
Kim
Seok-Jung
SJ
Department of Orthopedic Surgery, Catholic University College of Medicine, Seoul, Korea. peter@catholic.ac.kr
Shin
Yong-Woon
YW
Yang
Kyu-Hyun
KH
Kim
Sang-Bum
SB
Yoo
Moon-Jib
MJ
Han
Suk-Ku
SK
Im
Soo-Ah
SA
Won
Yoo-Dong
YD
Sung
Yerl-Bo
YB
Jeon
Taek-Soo
TS
Chang
Cheong-Ho
CH
Jang
Jae-Deog
JD
Lee
Sae-Bom
SB
Kim
Hyun-Cho
HC
Lee
Soo-Young
SY
D000293:Adolescent; D000328:Adult; D000368:Aged; D000469:Alkaline Phosphatase / Q000378:metabolism; D001854:Bone Marrow Cells / Q000166:cytology; D002146:Bony Callus / Q000378:metabolism / Q000473:pathology; D018929:Cell Culture Techniques; D017690:Cell Transplantation; D002478:Cells, Cultured; D024042:Collagen Type I / Q000378:metabolism; D005260:Female; D017102:Fracture Healing; D050723:Fractures, Bone / Q000378:metabolism / Q000473:pathology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010006:Osteoblasts / Q000166:cytology / Q000378:metabolism / Q000637:transplantation*; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult
D024042:Collagen Type I; D000469:Alkaline Phosphatase