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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001601
Enrollment
10
Registered
2008-12-26
Start date
2007-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis of the Femoral Head

Interventions

Period: 2 years Volume:50000000 of mesenchymal stem cell Number:1 Case number intervention: 10 cases

Sponsors

Department of Orthopedic Surgery, Kyoto University Hospital
Lead Sponsor
Center for Cell and Molecular Therapy, Kyoto University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Clinical stage of Xray evaluation:Stage 3A and Stage 3B

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
X-ray evaluation of clinical stage on the point of preoperation and two years after operation

Secondary

MeasureTime frame
Clinical score and bone volume on the point of preoperation, one year after operaion and two years after operation

Countries

Japan

Contacts

Public ContactIzumi Hashimoto

Kyoto University Hospital Department of Orthopaedic Surgery

seikei@kuhp.kyoto-u.ac.jp075-751-4400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026