A Pilot Clinical Trial of "ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue (XCEL-MT-OSTEO- ALPHA) in Osteonecrosis of the Femoral Head
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
研究概览
简要总结
The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head in comparison to the standard treatment of isolated core decompression.
XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue.
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the progression to collapse of the femoral head.
详细描述
Prospective, open-label with blinded assessor, randomized, parallel, single-dose phase I-II clinical trial in which 24 patients affected with osteonecrosis of the femoral head ARCO grade I or II will enter the trial with the primary objective of assessing the feasibility and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in osteonecrosis of the femoral head. Secondary objectives are to assess the efficacy of the implantation by imaging (magnetic resonance imaging) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and WOMAC Index).
Patients will be randomized to one of the two treatment arms (core decompression and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue or the standard treatment of isolated core decompression). Thereafter, patients will be followed for 12 months.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 50 years of age (male and female)
- •Osteonecrosis of the hip ARCO grade I or II
- •Abscence of systemic or local infection
- •Laboratory tests with no relevant abnormal findings that contraindicate the surgery.
- •Informed Consent Form signed
- •The patient is able to understand the nature of the study
排除标准
- •Osteonecrosis of the hip secondary to femoral neck fracture
- •Patients with no closed cartilage
- •Surgical implants in the femoral head
- •Septic arthritis
- •Patients with severe renal insufficiency
- •Patients expecting or with liver transplantation
- •Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis.
- •Pregnant woman or intended to become pregnant, or breath feeding
- •Neoplasia within the previous 5 years, or without remission
- •Immunosuppressive states
- •The patient is legally dependent
- •Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
- •Cardiac pacemaker, allergy to contrast or any other condition that contraindicates the MRI with contrast agents
- •Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- •The patient does not accept to be followed-up for a period thar could exceed the clinical trial length
结局指标
主要结局
Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
时间窗: 12 months
Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months
Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
时间窗: 12 months
Feasibility will be measured by assessing the percentage of patients to which bone marrow puncture is made are thereafter treated and by checking the cascade of procedures to confirm the global process is viable.
次要结局
- Dynamic changes of signal intensity(6 and 12 months)
- Bone regeneration by measuring the necrotic angle using the modified Kerboul method(6 and 12 months)
- Clinical outcomes (SF-36)(3, 6 and 12 months)
- Clinical outcome (WOMAC)(3, 6 and 12 months)
- Clinical outcomes (pain) by Visual Analogue Scale (VAS)(7 days and at 3, 6 and 12 months)