NCT02065167已完成2 期
Evaluation of Safety and Feasibility of Bone Marrow Derived Autologous MSCs to Enhance Bone Healing in Patients With Avascular Necrosis of the Femoral Head
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 12
- 主要终点
- Complication rate
研究概览
简要总结
The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.
详细描述
To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65, both sexes
- •Early avascular necrosis of the fem oral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC)
- •Sym ptom atic osteonecrosis with less than 6 months of evolution
- •Able to provide informed consent, and signed informed consent
- •Medical health care coverage
排除标准
- •Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
- •Participation in another therapeutic trial in the previous 3 m onths
- •Stages 3 or m ore (Ficat and Arlet) or III or m ore (Steinberg) of severe fem oral head osteonecrosis,primarily based on diagnosis by im aging (X-Rays, MRI).
- •Flattening or collapse of the fem oral head (Steinberg stage IV) or articular cartilage collapse at the time of core decompression surgery.
- •Septic arthritis.
- •Stress fracture.
- •Non-osteonecrosis metabolic bone diseases (particularly Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism , fibrous dysplasia monostotic, polyostotic McCune-Albright syndrome] and osteopetrosis).
- •Any active bisphosphonate treatment or any history of intravenous (IV) treatment.
- •History of prior or concurrent diagnosis of HIV-, Hepatitis-B- or Hepatitis-C-infection
- •Active hepatitis B or hepatitis C infection at the time of screening.
- •Known allergies to products involved in the production process of MSC.
- •History of neoplasia or current neoplasia in any organ.
- •Corticoid or immunosuppressive therapy more than one week in the two months prior to study inclusion
- •Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 m g/day) within 6 months after surgery.
- •Patients who are in active treatment for cancer or blood dyscrasia, or have received chemotherapy, radiotherapy or immunotherapy in the past 2 years.
- •History of regular alcohol consumption exceeding 2 drinks/day within 6 months of screening and/or history of illicit drug use.
- •Serum AST (SGO T)/ALT (SGPT) > 2.5 X (institutional standard range).
- •MRI-incompatible internal devices (pacemakers, aneurysm clips, etc).
- •Body mass index (BMI) of 40 kg/m ² or greater.
- •Patients unable to tolerate general anesthesia defined as an American Society of Anesthesiologists (ASA) criteria of >
- •Insulin dependent diabetes
- •Patients with poorly controlled diabetes mellitus (HbA1C > 8%), or with peripheral neuropathy, or known concomitant vascular problems.
- •Patients receiving treatment with hematopoietic growth factors or anti-vasculogenesis or antiangiogenesis treatment.
- •Traumatic osteonecrosis.
- •Adult in the care of a guardian (Subject legally protected)
- •Im possibility to meet at the appointments for the clinical follow up.
结局指标
主要结局
Complication rate
时间窗: 12 months
Includes early local complication rate plus global complication rate, as the percentage of patients with local or general complications at 52 weeks.
次要结局
- complication rate(6,12,24,104 weeks)
- serum levels of bone turnover markers(12 and 24 weeks)
- Progression of disease to the next stage(12 months)
- Amount of necrotic bone in the femoral head in MRI(12 weeks and 52 weeks)
- Pain (VAS)(6,12,24,52,104 weeks)
研究者
Prof Enrique Gomez-Barrena
Full Professor and Chair of orthopaedic surgery
Universidad Autonoma de Madrid
研究点 (12)
Loading locations...
相似试验
终止
不适用
Autologous Mesenchymal Stem Cell Transplant for Parkinson's DiseaseParkinson's DiseaseNCT00976430Jaslok Hospital and Research Centre5
已完成
1 期
Intravitreal Injection of MSCs in Retinitis PigmentosaRetinitis PigmentosaNCT01531348Mahidol University14
Unknown
1 期
Biological Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisNCT02193893Pomeranian Medical University Szczecin50
已完成
1 期
Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke PatientsIschemic StrokeNCT00859014The University of Texas Health Science Center, Houston25
进行中（未招募）
不适用
Evaluation of safety of celular therapy derived of bone marrow to help bone healing in patients with avascular necrosis of the hipEUCTR2012-002010-39-ROniversidad Autónoma de Madrid30