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

Phase 1

• Conditions: Osteonecrosis of the Femoral Head

• Registration Number: JPRN-UMIN000001601
• Lead Sponsor: Department of Orthopedic Surgery, Kyoto University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-26
• Study Completion: 2011-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified