EUCTR2012-002010-39-IT进行中（未招募）1 期
Evaluation of safety and feasibility of bone marrow derived autologous MSCs to enhance bone healing in patients with avascular necrosis of femoral head - REBORNE (ORTHO-2CT)
niversidad Autónoma de Madrid0 个研究点目标入组 30 人开始时间: 2013年12月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age 18 to 65, both sexes
- •-Early avascular necrosis of the femoral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC)
- •-Symptomatic osteonecrosis with less than 6 months of evolution
- •-Able to provide informed consent, and signed informed consent
- •-Medical health care coverage
- •-Able to understand and accept the study constraints
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 months
- •-Stages 3 or more (Ficat and Arlet) or III or more (Steinberg) of severe femoral head osteonecrosis, primarily based on diagnosis by imaging (X-Rays, MRI).
- •-Flattening or collapse of the femoral 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 (confirmed by serology or PCR)
- •-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 mg/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 (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening and/or history of illicit drug use.
- •-Serum AST (SGOT)/ALT (SGPT) > 2.5 X (institutional standard range).
- •-MRI-incompatible internaldevices (pacemakers, aneurysm clips, etc).
- •-Body mass index (BMI) of 40 kg/m² or greater.
- •-Patients unable to tolerate general anesthesia defined as an American Society of Anesthesiologists (ASA) criteria of > 2.
- •-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)
- •-Impossibility to meet at the appointments for the clinical follow up.
研究者
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