ClinicalTrials.gg
CompletedNCT00916981Updated Feb 23, 2012

Treatment of Atrophic Nonunion by Preosteoblast Cells

A Phase 1/2 interventional study of percutaneous autologous preosteoblast cells implantation in Pseudarthrosis and Fractures, Ununited, sponsored by Jean-Philippe Hauzeur. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-23.

Sponsored by Jean-Philippe Hauzeur · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pseudarthrosis
  • Fractures, Ununited

Keywords

  • pseudarthrosis
  • Treatment
  • osteoblast grafting
  • cell therapy
  • nonunion
03

In context

Pseudarthrosis

41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.

This study's enrollment of 30 is above the median of 22 across 25 interventional studies indexed under Pseudarthrosis.

Browse Pseudarthrosis studies →

Lead sponsor

This is the only study on the registry with Jean-Philippe Hauzeur as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Fracture of a long bone having insufficient healing after minimum 6 months.
  • Be able and willing to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Evidence of malignant disorder in the past five year.
  • Patient who is positive for an , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

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Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

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05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Interventions

  • Procedurepercutaneous autologous preosteoblast cells implantation

    percutaneously injection of preosteoblast into the nonunion under radioscopic control

    Also known as: PREOB

06

What researchers measure

Primary outcomes

  1. radiological progression of bone fusion

    monthly

    Time frame: 1, 2, 3, 4, 5, 6 months

Secondary outcomes

  1. reduction of pain using VAS

    Time frame: each month

07

Study locations

1 site
  • CHU Sart Tilman
    Liege, Liège 4000, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2008, a primary completion of Jun 2009 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2009
First posted
Jun 10, 2009
Start
Nov 2008
Primary completionActual
Jun 2009
CompletionActual
Jun 2009
Last update
Feb 23, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00916981
Lead sponsor
Jean-Philippe Hauzeur
Responsible party
Jean-Philippe Hauzeur (Principal investigator, University of Liege) — Sponsor-investigator
First posted
Jun 10, 2009
Start date
Nov 2008
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Feb 23, 2012

Study contacts

Jean-Philippe Hauzeur, MD, PhD
principal investigator · University of Liège, Belgium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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