NCT01700920已完成2 期
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
- •Stadiums <IIIC ARCO ranking
排除标准
- •Those on investigator judgment not in a good position to tolerate the procedure.
- •Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
- •Serious illness uncontrolled
- •Pregnant women
- •Patients with HIV infection +
- •Acute infection (in the previous 15 days) or chronic (other than HIV)
- •Previous treatments of osteonecrosis
- •Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.
- •Lack of informed consent or revocation thereof.
研究组 & 干预措施
Mesenchymal Stem Cell
Experimental
Cell suspension mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products.
They employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight.
Pharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head.
干预措施: bone marrow aspirate (Procedure)
研究者
研究点 (1)
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