NecrosisPhase 1NCT00821470
Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation
A Phase 1 study testing core decompression and Bone marrow implantation into the necrotic lesion in people with Necrosis, run by Erasme University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Necrosis
- What is being tested?
- core decompression and Bone marrow implantation into the necrotic lesion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 1999to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARCO stage 1 or 2 osteonecrosis of the femoral head
Who cannot join
- The investigators excluded patients with evidence of a malignant disorder during the past five years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study
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.
- Conditions
- Necrosis
- Being tested
- core decompression, Bone marrow implantation into the necrotic lesion
- Keywords
- osteonecrosis, bone marrow, core decompression, femoral head
- Medical subject headings
- Necrosis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core decompressionProcedure or surgery
core decompression procedure only
Bone marrow implantation into the necrotic lesionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| bone marrow graft group | Experimental | core decompression + bone marrow implantation into the necrotic lesion Receives: Procedure: core decompression; Procedure: Bone marrow implantation into the necrotic lesion |
| control | Active comparator | core decompression Receives: Procedure: core decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Score
Measured: 60 months
Secondary outcomes (1)
Disease progression defined as progression to a fractural stage of osteonecrosis
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 1999
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Investigators
- valerie gangji, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821470
- Sponsor's protocol ID
- ref. 98/20
- Status last verified
- Feb 2020
- First submitted
- 12 Jan 2009
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study
- ClinicalTrials.gov ID
- NCT00821470
- Acronym / sponsor ID
- ref. 98/20
- Conditions
- Necrosis
- Keywords
- osteonecrosis, bone marrow, core decompression, femoral head
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- Jan 1999
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bone marrow graft group | Experimental | Procedure: core decompression, Procedure: Bone marrow implantation into the necrotic lesioncore decompression + bone marrow implantation into the necrotic lesion |
| control | Active comparator | Procedure: core decompressioncore decompression |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ARCO stage 1 or 2 osteonecrosis of the femoral head
Key exclusion criteria (1 listed)
- The investigators excluded patients with evidence of a malignant disorder during the past five years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| core decompressioncore decompression procedure only | Procedure or surgery | bone marrow graft group, control |
| Bone marrow implantation into the necrotic lesion | Procedure or surgery | bone marrow graft group |
Primary outcome
WOMAC Score
Time frame: 60 months
1 secondary outcome
Disease progression defined as progression to a fractural stage of osteonecrosis
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
valerie gangji principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing core decompression and Bone marrow implantation into the necrotic lesion in people with Necrosis, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Score (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.