Treatment of Nonunion After Fractures (Pseudoartrosis) Using Mesenchymal Stromal Cells (MSCs)
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical evaluation
研究概览
简要总结
The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect.
详细描述
Nonunion (pseudoarthrosis) is one of the most serious complications of bone fracture. Even though different treatments have been used to repair nonunion bone defects, most of them have limitations, like morbidities, limited supply, frequent treatment failure, and high cost.
Based on the knowledge that MSC have multipotential capacity of differentiation into bone, cartilage, fat, and endothelial cells, and also, play a key role in the process of bone formation and fracture repair. In this study, we evaluated the use the bone regeneration capacity of autologous or allogeneic BM-MSC, as a potential therapeutic strategy to induce formation of new bone tissue and fracture healing.
A bioengineering construct, constituted by MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, wich is implanted at the nonunion site defect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-traumatic nonunion diagnosis (Pseudoarthrosis) with or without previous ortopaedic treatment
- •Patients with or without previous orthopaedic treatment
- •Presence of nonunion 9 month or more
- •Ossification failure in the non-union area, with an approximate size of 0.5 to 4 cm length
排除标准
- •Evidence of infection at the nonunion site (Osteomielitis)
- •Evidence of cutaneous lesion at the site of pseudoartrosis
- •Viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections
- •Autoimmune diseases
- •Neoplastic diseases
- •Pregnancy
- •Major metabolic disorders
- •Treatment with steroids
- •Other conditions or circumstances that compromise the study participation according to medical criteria
结局指标
主要结局
Clinical evaluation
时间窗: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Time of surgical wound evolution, surgically intervened limb evolution, movility
Bone consolidation
时间窗: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Time of development changes in bone consolidation by radiological studies
次要结局
未报告次要终点
研究者
Dylana Diaz Solano
Research Associate
Instituto Venezolano de Investigaciones Cientificas