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临床试验/NCT00851162
NCT00851162撤回2 期

Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions

Emory University2 个研究点 分布在 1 个国家开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
试验地点
2
主要终点
Time to fill bony defect

研究概览

简要总结

The purpose of this study is to determine whether using mesenchymal stem cells will heal benign bone lesion defects faster than demineralized bone matrix

详细描述

Orthobiologics have recently become a mainstay in treating bony defects whether related to trauma, tumor, or other various reconstructive entities.1 Historically, benign bone growths that were excised, would be filled with either cement, autograft bone, or allograft substances. More recently, other substances have been utilized. These substances carry any or all osteoinductive, osteoconductive, or osteogenic properties. Various materials have been used to fill bony voids specifically related to benign bone growths. Trinity™ by Blackstone Medical inc. is an allograft substance that has recently began utilization. The difference in Trinity compared to various other allografts is that it utilizes mesenchymal stem cells (MSC) along with an allograft carrier to incorporate and induce bone formation. Previously, in order for stem cells to be included in grafting, it would require bone marrow aspiration and the morbidity that is associated with iliac crest bone grafting.

Trinity MSC's are pre-immunodepleted and therefore, do not stimulate local T-cell proliferation but instead are activated to act as osteoblasts and stimulate bone formation. This local response, could accelerate healing, earlier weight-bearing, healing, and filing of bone voids in patients that have had excision of bony masses. In previous animal models, the use of MSC's have been shown to increase bone healing in critical sized defects.

Trinity is currently approved for FDA use in bone defects specifically within the spine or trauma. It has not been shown to have any significant adverse events over standard bone substitute products. We hypothesize benign bone lesions that undergo curettage and filling with Trinity will heal faster than bone lesions filled with basic bone grafting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Ages > 11 years
  • Benign bone lesion

排除标准

  • Previous surgery

结局指标

主要结局

Time to fill bony defect

时间窗: Two to 52 weeks

次要结局

  • Adverse reaction from bone graft(Immediately after surgery to one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shervin Oskouei

MD

Emory University

研究点 (2)

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