Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation

Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821470
• Other study ID #: ref. 98/20
• Status: Completed
• Phase: Phase 1
• Start date: January 1999
• Est. completion date: September 2008

Study information

• Verified date: February 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Necrosis
• Osteonecrosis

Intervention

Procedure:
• core decompression
core decompression procedure only
• Bone marrow implantation into the necrotic lesion

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Erasme University Hospital	Fonds National de la Recherche Scientifique

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC Score		60 months
Secondary	Disease progression defined as progression to a fractural stage of osteonecrosis		60 months