JPRN-UMIN000001601
Completed
Phase 1
Clinical trial of the new treatment for osteonecrosis using autologous bone marrow stromal cells - Clinical trial for osteonecrosis using autologous bone marrow stromal cells
Department of Orthopedic Surgery, Kyoto University Hospital0 sites10 target enrollmentDecember 26, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Orthopedic Surgery, Kyoto University Hospital
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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