massive bone defects, fracture non-union
Conditions
Interventions
Mesenchymal stem cells that are culture-expanded from bone marrow aspirates are integrated to interconnected porous ceramics and osteoblastic differentiation is induced to generate "
cultured bone"
- a living bone substitute. The cultured bone is implanted to bone void after the removal of bone tumor.
Sponsors
Osaka University Graduate School of Medicine, Department of Orthopedics
Osaka University Hospital, Medical Center for Translational Research National Institute of Advanced Industrial Science and Technology, Research Institute for Cell Engineering
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with benign bone tumors or tumor-like conditions of bone
Exclusion criteria
Exclusion criteria: Active local infection Serious complications including malignancies Diabetes Dialysis for renal failure Under the influence of steroids or other drugs that affect bone metabolism Infectious diseases (HIV, HBV, HCV, HTLV, syphilis) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Periodical evaluation of osseous integration by plain X-ray (radiographic evaluation for ceramic bone substitute proposed by Myoui, et al.) Adverse events (National Cancer Institute Common Toxicity Criteria Ver. 2, Japanese version, JCOG version) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall judgment by multimodal imaging, quantitative radiopacity by aluminum step, BMD by DEXA, histological evaluation, functional evaluation, QOL assessment by SF-36 | — |
Countries
Japan
Contacts
Public ContactAkira Myoui
Osaka University Hospital Medical Center for Translational Research
Outcome results
None listed