A Pilot Clinical Trial of ex Vivo Expanded Allogenic Adult Stem Cells Combined With Allogenic Human Bone Tissue (XCEL-MT-OSTEO-BETA) in Proximal Femur Fractures in Elderly Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests.
研究概览
简要总结
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire.
详细描述
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor phase I-II pilot study.
Thirty-two (32) elderly patients (70-85 years of age) with type 31A2 y 31A3 fracture of the femur (AO/ASIF (Association for the Study of Internal Fixation) classification) admitted at the emergency room of the Hospital Clinic of Barcelona will be randomized 1:1 to one of the two treatment-arms (endomedullary nailing + XCEL-MT-OSTEO-BETA or isolated endomedullary nailing as the standard treatment). Once surgically treated, patients will be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire (EUROQOL-5D).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between70 and 85 years old
- •Proximal femur fracture type 31A3 31a2 classification AO/ASIF.
- •Deambulation prior to fracture.
- •Written informed consent of the patient or family members.
排除标准
- •Presence of implants at proximal femur level.
- •Presence of local or systemic septic process.
- •Septic arthritis.
- •Dementia of any type.
- •Hematological and biochemical analysis with significant alterations that contraindicate surgery.
- •Patients with positive serology for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis.
- •Neoplastic disease detected in the last five years or without complete remission.
- •Immunosuppressive status.
- •Patients who received corticosteroids in the 3 months prior to study initiation.
- •Simultaneous participation in another clinical trial or treatment with another investigational product within 3 months prior to inclusion in the study.
- •Other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria.
- •Patient refusal to be followed by a period that may exceed the clinical trial itself.
研究组 & 干预措施
Standard treatment
Standard surgical treatment with isolated endomedullary nailing
干预措施: Surgical treatment (Procedure)
XCEL-MT-OSTEO-BETA
Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing
干预措施: XCEL-MT-OSTEO-BETA (Drug)
XCEL-MT-OSTEO-BETA
Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing
干预措施: Surgical treatment (Procedure)
结局指标
主要结局
safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests.
时间窗: 12 months
Adverse events, physical exam, laboratory tests.
次要结局
- efficacy through xRay(1, 3 and 6 months)
- efficacy by quality of life questionnaire(3, 6 and 12 month)
- efficacy through CT scan(3 months)
- efficacy by clinical assessment(1, 3 and 6 month)