Phase II Clinical Trial of Tissue Engineering Based on the Use of Mononuclear Cells From Autologous Bone Marrow Seeded on Porous Tricalcium Phosphate Biomaterial in Patients With Pseudoarthrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Time needed to repair the focus of necrosis measured by pain radiography
研究概览
简要总结
The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone graft.
详细描述
An estimated 10% of closed fractures and between 35-45% in cases of open fractures, are at risk of developing a delay in the process of consolidation or a complete failure of it (pseudoarthrosis) depending on location , severity of trauma on bone, soft tissue and vascular structures Some of these cases are refractory to all treatment methods available today, requiring numerous interventions with the potential risk for recurrent infections that they carry. For this reason, its treatment remains a challenge for the orthopedic surgeon.
Recent advances in knowledge of cellular and molecular biology related to the mechanism of bone repair and biomaterials science have been joined in a new discipline called tissue engineering, its implementation in clinical practice is being done so progressive.
Cell therapy based on the use of adult stem cells (MSCs) derived from autologous bone marrow, introduces new applications for the repair of fractures including pseudoarthrosis and avascular bone necrosis.
Its mechanism of action does not focus only on their local action, but also in the release of signaling molecules with autocrine and paracrine action through recruitment and activation of endogenous MSCs to osteoblastic differentiation and bone tissue regeneration.
On the other hand, the seeding of MSCs on biomaterials (natural or synthetic) is more effective, to facilitate adherence, proliferation and extracellular matrix production in the area where implanted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pseudarthrosis of tibia established any cause with at least 9 months.
- •The pseudarthrosis is not to show signs of healing in the last 3 months.
- •The pseudarthrosis subsidiary should not be solely osteosynthesis treatment.
- •Age between 18 and 75 years.
- •Serology Human Immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) negative.
- •Negative pregnancy test in women of childbearing age.
- •Patient sufficient guarantees of adherence to protocol.
- •Signature written informed consent before a witness
排除标准
- •Systemic infection.
- •Septic pseudoarthrosis.
- •Insufficient skin coverage at the site of nonunion.
- •Vascular insufficiency in the affected limb.
- •Pathological fracture.
- •Concomitant psychiatric or neurological disease.
- •Concurrent or prior malignancy treated with chemotherapy over a period of less than 1 year.
- •Concomitant severe disease not well controlled.
- •Inclusion in other clinical trials.
- •Inability to understand the informed consent
结局指标
主要结局
Time needed to repair the focus of necrosis measured by pain radiography
时间窗: Baseline and every 14 days up to 180 days
次要结局
- Pain scale(Baseline and every 14 days up to 180 days)
- Technical success(6 months)
- Morbidity(6 months)
- Absence of adverse events(6 months)
- physical exploratory(Baseline and every 14 days up to 180 days)
- Analgesia Scale(Baseline and every 14 days up to 180 days)