PseudarthrosisPhase 1/2NCT00916981
Treatment of Atrophic Nonunion by Preosteoblast Cells
A Phase 1/2 study testing percutaneous autologous preosteoblast cells implantation in people with Pseudarthrosis and Fractures, Ununited, run by Jean-Philippe Hauzeur at 1 site in Belgium.
Trial summary
Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudarthrosis, Fractures, Ununited
- What is being tested?
- percutaneous autologous preosteoblast cells implantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2008to Jun 2009
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fracture of a long bone having insufficient healing after minimum 6 months.
- Be able and willing to participate in the study.
Who cannot join
- Evidence of malignant disorder in the past five year.
- Patient who is positive for an HIV, hepatitis B or C infection.
- Insufficient reduction of the fracture with displaced fragments.
- Evidence of local sepsis by biological parameters and/or positive isotopic scan using leucocytes labelled by Indium.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Refractory Non-union Fractures by Pre-osteoblast Cells Grafting : a Pilot Study.
Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. First of all good surgical techniques are stable immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is required. Numerous techniques have been developed ranging from invasive interventions (including internal fixation with the use of bone graft or bone graft substitutes) to non invasive procedures (ultrasound and pulsed electromagnetic fields).
Recently, autologous cell therapy was presented as an interesting approach. The concept of such therapies is based on the effect of stem cells presented in the bone marrow and able to be transformed in osteoblast cells. The percutaneous technique of autologous bone-marrow grafting is a minimally invasive alternative able to produce a good healing of the fracture. The efficacy is dependent of the concentration in progenitor cell reinjected. An optimization of this type of treatment could be achieved using a technique to increase the differentiation of the bone marrow cells in preosteoblasts before the injection in situ by an adequate culture. Therefore we would like to start a pilot open study on the feasibility and the efficacy of implantation of preosteoblasts into nonunion. Two different presentations exist: the atrophic and the hypertrophic pseudarthrosis in relationship with radiological features of bone proliferation at the tip of bone fragments. Some data support that atrophic and hypertrophic nonunion fractures could have different physiopathological factors. So, in a first time we only would evaluate the atrophic form and to determine in an open study the effect of the implantation of preosteoblasts into atrophic nonunion.
Read the detailed description
We will recruit 30 patients having a atrophic nonunion fracture of long bone present for minimum 6 months.50 ml of bone marrow harvest will be performed under local anaesthesia 3 weeks before the implantation. After three weeks of culture, preosteoblastic cells will be injected into the site of pseudarthrosis under radioscopic control, using percutaneously a 3 mm trephine.
An immobilization and non weight-bearing of the bone will be respected during the first month after the injection. If callus could be observed on radiographs, partial mobilization and weight-bearing will be allowed during the second month.
- Conditions
- Pseudarthrosis, Fractures, Ununited
- Being tested
- percutaneous autologous preosteoblast cells implantation
- Keywords
- pseudarthrosis, Treatment, osteoblast grafting, cell therapy, nonunion
- Medical subject headings
- Pseudarthrosis, Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous autologous preosteoblast cells implantationProcedure or surgery
Also called PREOB
percutaneously injection of preosteoblast into the nonunion under radioscopic control
What is being measured
The primary outcome is the main question the study is designed to answer.
radiological progression of bone fusion
monthly
Measured: 1, 2, 3, 4, 5, 6 months
Secondary outcomes (1)
reduction of pain using VAS
Measured: each month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudarthrosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean-Philippe Hauzeur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean-Philippe Hauzeur, University of Liege
- Investigators
- Jean-Philippe Hauzeur, MD, PhD, Principal investigator, University of Liège, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916981
- Sponsor's protocol ID
- ref:2006-73
- Status last verified
- Feb 2012
- First submitted
- 3 Jun 2009
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Refractory Non-union Fractures by Pre-osteoblast Cells Grafting : a Pilot Study.
- ClinicalTrials.gov ID
- NCT00916981
- Acronym / sponsor ID
- ref:2006-73
- Conditions
- Pseudarthrosis, Fractures, Ununited
- Keywords
- pseudarthrosis, Treatment, osteoblast grafting, cell therapy, nonunion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jean-Philippe HauzeurUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 10 Jun 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.
Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. First of all good surgical techniques are stable immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is required. Numerous techniques have been developed ranging from invasive interventions (including internal fixation with the use of bone graft or bone graft substitutes) to non invasive procedures (ultrasound and pulsed electromagnetic fields).
Recently, autologous cell therapy was presented as an interesting approach. The concept of such therapies is based on the effect of stem cells presented in the bone marrow and able to be transformed in osteoblast cells. The percutaneous technique of autologous bone-marrow grafting is a minimally invasive alternative able to produce a good healing of the fracture. The efficacy is dependent of the concentration in progenitor cell reinjected. An optimization of this type of treatment could be achieved using a technique to increase the differentiation of the bone marrow cells in preosteoblasts before the injection in situ by an adequate culture. Therefore we would like to start a pilot open study on the feasibility and the efficacy of implantation of preosteoblasts into nonunion. Two different presentations exist: the atrophic and the hypertrophic pseudarthrosis in relationship with radiological features of bone proliferation at the tip of bone fragments. Some data support that atrophic and hypertrophic nonunion fractures could have different physiopathological factors. So, in a first time we only would evaluate the atrophic form and to determine in an open study the effect of the implantation of preosteoblasts into atrophic nonunion.
Detailed description
We will recruit 30 patients having a atrophic nonunion fracture of long bone present for minimum 6 months.50 ml of bone marrow harvest will be performed under local anaesthesia 3 weeks before the implantation. After three weeks of culture, preosteoblastic cells will be injected into the site of pseudarthrosis under radioscopic control, using percutaneously a 3 mm trephine.
An immobilization and non weight-bearing of the bone will be respected during the first month after the injection. If callus could be observed on radiographs, partial mobilization and weight-bearing will be allowed during the second month.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fracture of a long bone having insufficient healing after minimum 6 months.
- Be able and willing to participate in the study.
Key exclusion criteria (4 listed)
- Evidence of malignant disorder in the past five year.
- Patient who is positive for an HIV, hepatitis B or C infection.
- Insufficient reduction of the fracture with displaced fragments.
- Evidence of local sepsis by biological parameters and/or positive isotopic scan using leucocytes labelled by Indium.
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 |
|---|---|---|
| percutaneous autologous preosteoblast cells implantationAlso: PREOBpercutaneously injection of preosteoblast into the nonunion under radioscopic control | Procedure or surgery | – |
Primary outcome
radiological progression of bone fusion
Time frame: 1, 2, 3, 4, 5, 6 months
monthly
1 secondary outcome
reduction of pain using VAS
Time frame: each month
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 23 Feb 2012.
Related trials for Pseudarthrosis
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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.
Jean-Philippe Hauzeur, MD, PhD principal investigator
University of Liège, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing percutaneous autologous preosteoblast cells implantation in people with Pseudarthrosis and Fractures, Ununited, run by Jean-Philippe Hauzeur 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 2 inclusion and 4 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 23 Feb 2012. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
radiological progression of bone fusion (time frame: 1, 2, 3, 4, 5, 6 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 23 Feb 2012.