Treatment of bone diseases with porous ceramics integrated with autologous bone marrow derived mesenchymal cells

UMIN ID: UMIN000000649

Registered date:01/04/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: massive bone defects, fracture non-union
• Date of first enrollment: 2004/06/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: 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 Outcome: Overall judgment by multimodal imaging, quantitative radiopacity by aluminum step, BMD by DEXA, histological evaluation, functional evaluation, QOL assessment by SF-36

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Osaka University Graduate School of Medicine, Department of Orthopedics
• Secondary Sponsor: Osaka University Hospital, Medical Center for Translational Research National Institute of Advanced Industrial Science and Technology, Research Institute for Cell Engineering
• Source(s) of Monetary Support: None