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OpenTrials
Completed

NCT Number: NCT00821470

Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Erasme Hospital

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Core Decompression

Procedure

core decompression procedure only

Bone marrow implantation into the necrotic lesion

Procedure

Primary outcomes

  1. WOMAC Score

    Time frame: 60 months

Secondary outcomes

  1. Disease progression defined as progression to a fractural stage of osteonecrosis

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

  • Fonds National de la Recherche Scientifique

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2008
Study completion
2008
First posted
Jan 13, 2009
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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