Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation for Human Avascular Necrosis of the Lunate Bone of the Wrist (Kienbock's Disease)
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is usually progressive without treatment.
Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.
This study examined lunate core decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal cells for Its treatment potential.
Bone decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.
The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.
The Spss(v16) software will be used for data analysis.
详细描述
Kienböck's disease is characterized by avascular necrosis of the lunate wrist There is probably no single cause of avascular necrosis of the lunate. Its origin may involve multiple factors, such as the blood supply (arteries), the blood drainage (veins), and skeletal variations.
Current treatments are: at the early phase only observation. In the more advanced phases surgical techniques such as bone decompression.
A potential therapeutic strategy would be cell therapy, A source of such cells with a regenerative potential could be mesenchymal stem cells (MSCs).
The investigators will evaluate safety and efficacy of implantation of autologous BM-MSC (bone marrow-derived mesenchymal stromal cell) in 30 patients with Kienböck's disease in combination with bone decompression surgery. These patients will be followed up and data will be analyzed with spss(v16).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kienböck's disease without response to conservative treatment (physical and medical) for over 6 months
- •Both genders
- •Visual Analogue Scale of 4 or higher
- •Hematological and biochemical analysis with no significant alterations that contraindicates intervention
- •The patient is able to understand the nature of the study
- •Informed written consent of the patient
排除标准
- •Age over 65 or under 18 or legally dependent
- •Infection signs or positive serology for HIV, hepatitis and syphilis
- •Allergy to gentamicin, or to bovine, cattle or horse serum
- •Pregnancy or lactating
- •Pregnancy or breast-feeding
- •Neoplasia
- •Immunosuppression
- •Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
- •Other conditions that may, according to medical criteria, discourage participation in the study
结局指标
主要结局
Pain
时间窗: 3months
The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression.
Bone density
时间窗: 3 months
The improvement of bone density at least 3months after BM-MSC transplantation in MRI.
次要结局
- Infection: Presence of any sign or symptoms of infection(1week)
- Cyst formation: Presence of any cyst or mass formation(3months)
- Quality of life evaluated by Visual Analogue Score (VAS)(3 months)