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Clinical Trials/NCT00821470
NCT00821470CompletedPhase 1

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

Erasme University Hospital2 sites in 1 country21 target enrollmentStarted: January 1, 1999Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
21
Locations
2
Primary Endpoint
WOMAC Score

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Erasme University Hospital
Sponsor Class
Other

Study Sites (2)

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