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Clinical Trials/NCT00821470
NCT00821470
Completed
Phase 1

Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study

Erasme University Hospital1 site in 1 country21 target enrollmentJanuary 1999
ConditionsNecrosis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Necrosis
Sponsor
Erasme University Hospital
Enrollment
21
Locations
1
Primary Endpoint
WOMAC Score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Aseptic non traumatic osteonecrosis (ON) is a painful disorder of the hip which often leads, in its final stage, to femoral head collapse and subsequent total hip replacement. Core decompression of the hip is the most widespread procedure used to treat early stage ON of the femoral head. Notwithstanding the fact that this procedure has been employed for more than three decades (2), its efficacy remains controversial (3;4). Recently, one suggested that ON might be a disease of bone cells and/or of mesenchymal cells. The levels of activity and the number of mesenchymal stem cells in both the hematopoietic and in the stromal compartments of the bone marrow have been shown to be depressed in patients with ON of the femoral head (9). The investigators have showed previously that the capacity of osteoblastic cells to replicate was decreased in the proximal femur of patients with ON of the femoral head (10). This finding raised the possibility that bone marrow containing stromal cells which have many of the characteristics of stem cell for mesenchymal tissues including bone could be implanted into the necrotic lesion of the femoral head.

Registry
clinicaltrials.gov
Start Date
January 1999
End Date
September 2008
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Erasme University Hospital

Eligibility Criteria

Inclusion Criteria

  • ARCO stage 1 or 2 osteonecrosis of the femoral head

Exclusion Criteria

  • The investigators excluded patients with evidence of a malignant disorder during the past five years.

Outcomes

Primary Outcomes

WOMAC Score

Time Frame: 60 months

Secondary Outcomes

  • Disease progression defined as progression to a fractural stage of osteonecrosis(60 months)

Study Sites (1)

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