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Treatment of early stage osteonecrosis of the femoral head with implantation of autologous bone marrow-derived and cultured mesenchymal stem cells

Treatment of early stage osteonecrosis of the femoral head with implantation of autologous bone marrow-derived and cultured mesenchymal stem cells: a single centre randomised controlled interventional trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18167626
Enrollment
100
Registered
2010-02-09
Start date
2004-03-04
Completion date
Unknown
Last updated
2015-01-13

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 at early stage Musculoskeletal Diseases Osteonecrosis

Interventions

Osteonecrosis of the femoral head remains a significant health concern. Currently, core decompression combined with implantation of autologous bone marrow mononuclear cells appears to be an effective

Sponsors

Dalian University Zhongshan Hospital (China)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 to 45 years, either sex 2. Patients with hips at stages IC to IIC according to Association Research Circulation Osseous (ARCO) classification 3. Etiological factors including trauma, alcohol abuse, corticosteroid use, Caisson disease, hyperlipidemia, and idiopathic

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Current and previous infection 3. Skeletal immaturity 4. Immunosuppressive drug therapy 5. A history of inflammatory arthritis 6. Evidence of cardiovascular diseases 7. Prior systemic corticosteroid treatment 8. Mental health problems preventing adequate follow-up

Design outcomes

Primary

MeasureTime frame
Clinical outcome, assessed by the Harris Hip Score, measured pre-operatively and at 3 months, 6 months, 12 months, 30 months, and every 2 years post-operatively thereafter

Secondary

MeasureTime frame
Radiographic approaches are used to determine the progress in osteonecrotic stage and to assess the volume of the necrotic lesion in the femoral head, measured pre-operatively and at 3 months, 6 months, 12 months, 30 months, and every 2 years post-operatively thereafter

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026