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临床试验/NCT00916981
NCT00916981已完成1 期

Treatment of Refractory Non-union Fractures by Pre-osteoblast Cells Grafting : a Pilot Study.

Jean-Philippe Hauzeur2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年11月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
radiological progression of bone fusion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

radiological progression of bone fusion

时间窗: 1, 2, 3, 4, 5, 6 months

monthly

次要结局

  • reduction of pain using VAS(each month)

研究者

发起方
Jean-Philippe Hauzeur
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jean-Philippe Hauzeur

Principal investigator

University of Liege

研究点 (2)

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