NCT01643655已完成不适用
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
R-Bio1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Magnetic Resonance Imaging
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age :18-70, males and females.
- •Subjects who understand and sign the consent form for this study.
- •Clinical diagnosis of nontraumatic avascular necrosis of the femoral head
- •Steinberg stage I, II, ⅢA
- •Patients whose lesion is more than 30% (by Kim's Method)
排除标准
- •Patients who have collapsed femoral head
- •Patient has had a Core Decompression or Multiple Drilling in the affected hip
- •Patients who received osteoporosis medicines and parathyroid hormone drugs
- •Taking medications that use the immunosuppressive drugs and cytotoxic agents or unable to discontinue their use for the duration of the study
- •Taking medications that use the adrenocortical hormone drugs or unable to discontinue their use for the duration of the study
- •Subject unable to undergo MRI (i.e. patients with pace-maker, metallic hip prosthetic implants)
- •Women who are pregnant or breast feeding or planning to become pregnant during the study.
- •Positive serology for HIV and hepatitis
- •Serious pre-existing medical conditions like Cardiovascular Diseases, Cancer, Renal Diseases, Endocrine Diseases and Autoimmune Diseases
- •Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
- •Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
研究组 & 干预措施
Autologous Adipose Tissue Derived MSCs
Experimental
干预措施: Autologous Adipose Tissue derived MSCs Transplantation (Procedure)
结局指标
主要结局
Magnetic Resonance Imaging
时间窗: 96 weeks
To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs.
次要结局
- SPECT/CT(96 weeks)
- Hip X-ray(96 weeks)
- HHS (Harris Hip Score)(96 weeks)
- WOMAC (Western Ontario and McMaster Universities) Index(96 weeks)
- UCLA (University of California Los Angeles) hip questionnaire(96 weeks)
- Safety evaluation(96 weeks)
研究者
研究点 (1)
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