Treatment of Atrophic Nonunion by Preosteoblast Cells

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean-Philippe Hauzeur, University Hospital of Liege
ClinicalTrials.gov Identifier:
NCT00916981
First received: June 3, 2009
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Pseudarthrosis
Fractures, Ununited
Procedure: percutaneous autologous preosteoblast cells implantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Refractory Non-union Fractures by Pre-osteoblast Cells Grafting : a Pilot Study.

Resource links provided by NLM:


Further study details as provided by University Hospital of Liege:

Primary Outcome Measures:
  • radiological progression of bone fusion [ Time Frame: 1, 2, 3, 4, 5, 6 months ] [ Designated as safety issue: No ]
    monthly


Secondary Outcome Measures:
  • reduction of pain using VAS [ Time Frame: each month ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: percutaneous autologous preosteoblast cells implantation
    percutaneously injection of preosteoblast into the nonunion under radioscopic control
    Other Name: PREOB
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00916981

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

No publications provided

Responsible Party: Jean-Philippe Hauzeur, Principal investigator, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT00916981     History of Changes
Other Study ID Numbers: ref:2006-73
Study First Received: June 3, 2009
Last Updated: February 22, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital of Liege:
pseudarthrosis
Treatment
osteoblast grafting
cell therapy
nonunion

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

ClinicalTrials.gov processed this record on July 22, 2014