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临床试验/NCT01210950
NCT01210950已完成1 期

Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy

Royan Institute1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
6
试验地点
1
主要终点
effect of mesenchymal cell transplantation to decrease limb inequal

研究概览

简要总结

Limb-length discrepancy can be due to many causes. These are divided into three groups: congenital (from birth), developmental (from a childhood disease or injury that slows or damages the growth plates), and posttraumatic (from a fracture that leads to shortening of the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in), shortening of the long leg can be considered, especially for tall persons. For growing children, this can be easily accomplished with a small, minimally invasive, uncomplicated procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow derived mesenchymal stem cells can shorten the treatment period by acceleration of bone regeneration during distraction osteogenesis.

详细描述

Distraction osteogenesis has been widely utilized to treat leg length discrepancy, deformity, nonunion, osteomyelitis, and bone loss. It has been found that most difficult conditions can be resolved with this method. In this study the aim is to observe if mesenchymal stem cell transplantation can enhance new bone formation during distraction osteogenesis.Patients undergo bone distraction , and about 2-3 weeks after distraction mesenchymal stem cell are injected at the callus site. In the case of large bone gap, mesenchymal stem cells are seeded on bone matrix and then placed in the bone gap. Each patient is assessed at interval time of 1 month for 6 months post surgery by X-Ray and at month 6 post surgery by computed tomography(CT) scans.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • both gender
  • patient with limb-length discrepancy
  • Age:18-65

排除标准

  • Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease
  • Known allergic reaction to components of study treatment and/or study injection procedure
  • Patients infected with hepatitis B,C or HIV
  • pregnancy

结局指标

主要结局

effect of mesenchymal cell transplantation to decrease limb inequal

时间窗: 6 months

evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal

次要结局

  • improve life quality(12 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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