NCT02448121Unknown1 期
Treatment for Hip, Knee, Ankle and Shoulder Osteonecrosis With Autologous Mononuclear Cells Transplantation in People With Sickle Cell Disease
Federal University of Bahia0 个研究点目标入组 100 人开始时间: 2006年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 主要终点
- Change in Functional / Clinical Score of 10 points or more
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cells in sickle cell disease patients with osteonecrosis
详细描述
The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for sickle cell disease patients with osteonecrosis.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable sickle cell disease patients
- •FICAT classification of osteonecrosis, inclusive of Stage II.
- •Diagnosis will be based on X-Ray and magnetic resonance imaging (MRI).
- •No infection in affected bones at the time of surgery.
- •Patient competent to give informed consent.
- •Scoring at least 20 points on the pain and daily life activities questionnaire.
排除标准
- •FICAT stage III or more
- •Patients with a history of corticosteroids or on active therapy
- •Bone infection at the limb affected by necrosis
- •Recurrent painful crises,
- •Immunosuppressive drug therapy,
- •Pregnancy,
- •Presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of osteonecrosis of the femoral head
研究组 & 干预措施
Autologous bone marrow stem cell graft
Experimental
Autologous bone marrow stem cell implantation
干预措施: Autologous bone marrow stem cell graft (Procedure)
结局指标
主要结局
Change in Functional / Clinical Score of 10 points or more
时间窗: 60 months
Standardized and objective scoring system to rate patient's functional abilities
次要结局
- Numeric pain intensity scale (0-10)(60 months)
- Disease progression defined as progression to a fractural stage of osteonecrosis(60 months)
- Reoperation rate(60 months)
- Radiological progression(60 months)
研究者
Vitor Fortuna
PhD
Federal University of Bahia
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