Clinical trial of the new treatment for osteonecrosis using autologous bone marrow stromal cells

UMIN ID: UMIN000001601

Registered date:26/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Osteonecrosis of the Femoral Head
• Date of first enrollment: 2007/08/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Period: 2 years Volume:50000000 of mesenchymal stem cell Number:1 Case number intervention: 10 cases

Outcome(s)

• Primary Outcome: X-ray evaluation of clinical stage on the point of preoperation and two years after operation
• Secondary Outcome: Clinical score and bone volume on the point of preoperation, one year after operaion and two years after operation

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: Previous medical history against candidate bone Heavy smorker (Brinkman index>600) Warfarin treatment Diabetes mellitus (HbA1c>9.0%) Arteriosclerosis obliterans Pregnancy,during lactation Malignant neoplasm Cardiac infarction, brain infaction Rheumatoid arthritis Dialytic therapy Complication of blood disease Live less than 12 months Active infection Hypotension(systolic blood pressure<90mmHg) Low body weight(under 40kg) Bone marrow dysfunction (neutrophil<1500/mm3, Hb<11.0g/dL(male),Hb<10.0g/dL(women), Plt<100000/mm3) Patient with the anti-osteoporosis drug and steroid were changed within 3 months Patient which was judged as inadequate

Related Information

• Primary Sponsor: Department of Orthopedic Surgery, Kyoto University Hospital
• Secondary Sponsor: Center for Cell and Molecular Therapy, Kyoto University
• Source(s) of Monetary Support: Kyoto University Hospital,Ministry of Health, Labor, and Welfare Ministry of Education, Culture, Sports, Science, and Technology New Energy and Industrial Technology Development Organization