NIPH Clinical Trials Search

UMIN ID: UMIN000000649

Registered date:01/04/2007

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedmassive bone defects, fracture non-union
Date of first enrollment2004/06/01
Target sample size10
Countries of recruitmentJapan
Study typeInterventional
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.


Primary OutcomePeriodical 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 OutcomeOverall 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 minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteriaActive 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


public contact
Name Akira Myoui
Address 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan Japan
Telephone 06-6879-6551
Affiliation Osaka University Hospital Medical Center for Translational Research
scientific contact
Name Hideki Yoshikawa
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan Japan
Telephone 06-6879-3552
Affiliation Osaka University Graduate School of Medicine Department of Orthopedics