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Treatment of Atrophic Nonunion by Preosteoblast Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00916981
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : February 23, 2012
Information provided by (Responsible Party):
Jean-Philippe Hauzeur, University of Liege

Brief 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.

Condition or disease Intervention/treatment Phase
Pseudarthrosis Fractures, Ununited Procedure: percutaneous autologous preosteoblast cells implantation Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Refractory Non-union Fractures by Pre-osteoblast Cells Grafting : a Pilot Study.
Study Start Date : November 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Intervention Details:
  • Procedure: percutaneous autologous preosteoblast cells implantation
    percutaneously injection of preosteoblast into the nonunion under radioscopic control
    Other Name: PREOB

Primary Outcome Measures :
  1. radiological progression of bone fusion [ Time Frame: 1, 2, 3, 4, 5, 6 months ]

Secondary Outcome Measures :
  1. reduction of pain using VAS [ Time Frame: each month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00916981

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CHU Sart Tilman
Liege, Liège, Belgium, 4000
Sponsors and Collaborators
Jean-Philippe Hauzeur
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Principal Investigator: Jean-Philippe Hauzeur, MD, PhD University of Liège, Belgium

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Responsible Party: Jean-Philippe Hauzeur, Principal investigator, University of Liege Identifier: NCT00916981     History of Changes
Other Study ID Numbers: ref:2006-73
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: February 2012

Keywords provided by Jean-Philippe Hauzeur, University of Liege:
osteoblast grafting
cell therapy

Additional relevant MeSH terms:
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Fractures, Ununited
Fractures, Bone
Wounds and Injuries