Phase I Clinical Trial of Use of Autologous Bone Marrow Stem Cells Seeded on Porous Tricalcium Phosphate Matrix and Demineralized Bone Matrix in Patients With Osteonecrosis (MSC/ONM)
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of non-serious adverse events related to the procedure.
研究概览
简要总结
The purpose of this study is to evaluate the safety of use of autologous bone marrow stem cells seeded on porous tricalcium phosphate matrix and demineralized bone matrix in patients with osteonecrosis of the jaw by a prospective, single-center, open, nonrandomized and unblinded clinical trial.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mandibular osteonecrosis of any etiology defined by clinical and radiological examination.
- •Bone defect anteroposterior dimension less than or equal to 4 cm in the mandible or the maxilla 2.5, and / or bone bed sufficient to ensure the integrity of the construct during surgery.
- •No response to conservative treatment.
- •Provide sufficient assurance of adherence to protocol.
- •Provide written consent
- •Meet all the inclusion criteria
排除标准
- •Concomitant psychiatric illness.
- •Uncontrolled concomitant systemic disease.
- •Active infectious disease in the focus of mandibular osteonecrosis.
- •Neoplastic disease in complete remission less than 2 years.
- •Pregnant patients.
- •Patients with active feeding.
- •Patients physically fertile, defined as all women physiologically capable of becoming pregnant, UNLESS they are using reliable methods of contraception.
- •Patients with cardiac disease, renal, hepatic, systemic, immune that may influence patient survival during the test.
- •Inclusion in other clinical trials in active treatment.
- •Inability to understand the informed consent.
- •You need not meet any exclusion criteria
研究组 & 干预措施
MSC construct for Osteonecrosis
Patients with definite diagnosis of osteonecrosis of the jaw by clinical and radiological examination of any etiology will receive a construct made of Bone Marrow Stem Cell + Tricalcium Phosphate + Demineralized Bone Matrix (MSC+TP+DBM).
干预措施: MSC construct for Osteonecrosis (Biological)
结局指标
主要结局
Rate of non-serious adverse events related to the procedure.
时间窗: 24 months from baseline
Local infection of the surgical wound. Pseudarthrosis implant. Allergic reactions.
Rate of serious adverse events related to the procedure.
时间窗: 24 months from baseline
Apparition of Bone ischemic events. Neoformations.
次要结局
- Time to Repair the injury(24 months from baseline)
- Quality of life, measured by EuroQol-5D.(24 months from baseline)
- Local pain assessed by visual analog scale(24 months from baseline)
- Bone formation, measured by Computed tomography (mm)(24 months from baseline)