Cited by 111Bone fractures and treatmentsBone Tissue Engineering MaterialsPeriodontal Regeneration and Treatments

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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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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.

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Crossref · 10.1186/1471-2474-10-20

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Figures

Figure 1 Before staining, alkaline phosphatase staining, and alizarin red staining at 100 × magnification.(data not shown fully).
Figure 1 Before staining, alkaline phosphatase staining, and alizarin red staining at 100 × magnification.(data not shown fully).CC BY · PubMed Central
Figure 2 Type I collagen and alkaline phosphatase expression of cultured cells quantified by FACS analysis.(data not shown fully).
Figure 2 Type I collagen and alkaline phosphatase expression of cultured cells quantified by FACS analysis.(data not shown fully).CC BY · PubMed Central
Figure 3 Method for measuring the callus formation score in the fracture area. Slight callus formation is given 1 point. b) Bridging callus formation is given 2 points.
Figure 3 Method for measuring the callus formation score in the fracture area. Slight callus formation is given 1 point. b) Bridging callus formation is given 2 points.CC BY · PubMed Central
Figure 4 The recruitment pathways of the clinical trial.
Figure 4 The recruitment pathways of the clinical trial.CC BY · PubMed Central
Figure 5 a) The sum of the difference in callus formation scores in both groups. b) The callus formation scores in both groups at each time point.
Figure 5 a) The sum of the difference in callus formation scores in both groups. b) The callus formation scores in both groups at each time point.CC BY · PubMed Central
Figure 6 The callus formation scores according to the patient ages of the osteoblast injection group.
Figure 6 The callus formation scores according to the patient ages of the osteoblast injection group.CC BY · PubMed Central
Figure 7 The right tibia AP radiographs of a 47-year-old male patient before osteoblast injection (a) and eight weeks after injection (b) into the fracture of the tibia shaft.
Figure 7 The right tibia AP radiographs of a 47-year-old male patient before osteoblast injection (a) and eight weeks after injection (b) into the fracture of the tibia shaft.CC BY · PubMed Central

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Research works printed but not linked: 1

  1. Hauser DL, Pierre MA, Snyder BD: Bilateral variation of bone structure of the femur in normal adults measured by ex-vivo orthogonal radiography, DEXA, and QCT. 47th Annual Meeting, Orthopaedic Research Society. 2001

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Metadata

Authors
Kim, S.-J., Shin, Y.-W., Yang, K.-H., Kim, S.-B., Yoo, M.-J., Han, S.-K., Im, S.-A., Won, Y.-D., Sung, Y.-B., Jeon, T.-S., Chang, C.-H., Jang, J.-D., Lee, S.-B., Kim, H.-C., & Lee, S.-Y.
Affiliations
  • Inje University (KR)
  • Yonsei University (KR)
  • Konyang University (KR)
  • Dankook University Hospital (KR)
  • Catholic University of Korea (KR)
  • Sewon Cellontech (South Korea) (KR)
Corresponding author
Kim, Sang-Bum
Venue
BMC Musculoskeletal Disorders
Published
2009-02-12
Volume
10
Issue
1
Pages
20-20
ISSN
1471-2474 (ISSN-L)
OpenAlex
W1973452274
Cited by
111
References
14
Citations by year
2026: 5 · 2025: 2 · 2024: 5 · 2023: 6 · 2022: 4 · 2021: 13 · 2020: 8 · 2019: 5 · 2018: 3 · 2017: 6 · 2016: 8 · 2015: 9 · 2014: 5 · 2013: 12 · 2012: 5
FWCI
4.50
Type
journal article
Language
en
Open access
Locations
  • BMC Musculoskeletal Disorders (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
Funders
Korea Health Industry Development Institute
Topics
  • Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone fractures and treatments
  • Physical Sciences › Engineering › Biomedical Engineering › Bone Tissue Engineering Materials
  • Health Sciences › Dentistry › Periodontics › Periodontal Regeneration and Treatments
Keywords
bone marrow-derived mesenchymal stem cells, long bone fractures, callus formation, cell therapy safety, cell injection
MeSH terms
Adolescent, Adult, Aged, Alkaline Phosphatase, Bone Marrow Cells, Bony Callus, Cells, Cultured, Female, Humans, Male, Middle Aged, Osteoblasts, Transplantation, Autologous, Treatment Outcome, Fracture Healing, Cell Transplantation, Cell Culture Techniques, Collagen Type I, Fractures, Bone, Young Adult

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