EUCTR2018-000886-35-ES进行中（未招募）1 期
Evaluation of safety, feasibility and preliminary efficacy of MSCs from third party donors in the treatment of patients with osteonecrosis of the femoral head after allogeneic Stem Cell Transplantation (AloFem) - AloFem
Enrique Gomez-Barrena0 个研究点目标入组 7 人开始时间: 2018年4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
- 7
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: 8 to 55, both sexes
- •- Patients having received allogeneic haematological stem cell transplant (HSCT), due to hematologic diseases, in remission. The patient may be or have been under immunosupression.
- •- Osteonecrosis of the femoral head (MRI diagnosis): Ficat and Arlet 0, 1, 2 or 3 or ARCO stages 0, I, IIA, IIB, IIC, IIIA, IIIB, IIIC or Steinberg stages 0, I, II, III.
- •- Able to provide informed consent, and signed informed consent (by themselves or legal representative)
- •- Medical health care coverage
- •- Able to understand and accept the study constraints (by themselves or legal representative)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Disease in relapse
- •- Active infection of any location and aetiology
- •- Surgical contraindication of any cause
- •- Pregnancy, breastfeeding women and women who are of childbearing age and not practicing adequate birth control.
- •- Stage 4 (Ficat and Arlet) or IV and above (Steinberg) or ARCO IV, with severe femoral head osteonecrosis associated to acetabular changes, 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
- •- Any tumour infiltration of the femoral head and/or neck
- •- Other tumour infiltration with short-term life risk
- •- Stress or pathological fracture of the femoral neck
- •- Traumatic osteonecrosis
- •- Non-osteonecrosis metabolic bone diseases (particularly Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism, monostotic or polyostotic fibrous dysplasia, McCune-Albright syndrome and osteopetrosis)
- •- Any active bisphosphonate treatment (or 3 months before the trial, except in case they are used in the treatment of an acute disorder that requires prompt management, e.g., severe hypercalcemia, severe bone pain).
- •- Any evidence of HIV, Hepatitis B or Hepatitis C infection (confirmed by serology or PCR)
- •- Known allergies to products involved in the production process of MSC
- •- 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
- •- MRI incompatible internal devices (pacemakers, aneurysm clips, etc.)
- •- Impossibility to meet at the appointments for the clinical follow up
研究者
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