Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion

South China Research Center for Stem Cell and Regenerative Medicine0 个研究点目标入组 40 人开始时间: 2017年1月1日最近更新: 2016年6月28日

适应症

试验速览

阶段: 1 期
发起方
入组人数: 40
主要终点: Radiological progression of bone fusion

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Every patient with non union in the site of bone fracture and nonunion.
•Age more than 18 and less than 60 years old.
•Nonunion or delayed union.

排除标准

•Diagnosis of cancer.
•Pregnancy or breastfeeding.
•Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing.
•Any medical or psychiatric condition that in the researcher´s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial.
•Patients do not sign the consent forms

结局指标

主要结局

Radiological progression of bone fusion

时间窗: 12 months

After patients receiving mesenchymal stem cells or placebo, imaging control by X-ray and CT, and then analysis by software(ImageJ ) at 1, 6 and 12 months

次要结局

Comparison of the rate of complications between the 2 groups(12 months)
Incidence of increased temperature sensitivity by questionnaire(6 months)
Incidence and severity of infections at grafting sites by questionnaire(6 months)

研究者

发起方

South China Research Center for Stem Cell and Regenerative Medicine

申办方类型

Other

责任方

Sponsor

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