EUCTR2009-012929-11-BE进行中（未招募）1 期
Phase III, pivotal, multicentre, randomised, double-blind controlled Study to evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head - PREOB-ON3
Bone Therapeutics S.A.0 个研究点目标入组 130 人开始时间: 2011年6月21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
- 130
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
- •1. Men or women between 18 and 70 years (inclusive)
- •2. Ability to provide a written, dated, and signed informed consent prior to any study related procedure and to understand and comply with study requirements
- •3.Diagnosis of Osteonecrosis:
- •a.ARCO stage I associated with WOMAC® VA3.1 pain score =20 mm and necrotic angle sum =190° based on sagittal and coronal MRI views
- •b.ARCO stage II associated with WOMAC® VA3.1 pain score =20 mm if necrotic angle sum <190°
- •based on sagittal and coronal MRI views
- •c.ARCO stage II associated or not with pain if necrotic angle sum is =190° based on sagittal and coronal MRI views
- •d.Associated with corticosteroid and/or with alcohol abuse and/or idiopathic.
- •4.Normal haematology function, defined as:
- •leukocytes =3000/mm3, absolute neutrophils count =1500/mm3, platelets =140,000/mm3, and haemoglobin concentration =10g/dl (peripheral blood test)
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Exclusively diaphyseal or metaphyseal osteonecrotic lesion
- •2.Traumatic or hyperbaric osteonecrosis, or osteonecrosis associated with hemoglobinopathy or coagulopathy (e.g., thalassemia, sickle cell disease,…), or Gaucher’s disease
- •3.Osteoarthritis at the hip under evaluation defined as Kellgrens stage =2, as assessed by the Central Radiologist
- •4.Patients suffering from any medical conditions interfering with patient’s pain evaluation of the hip under evaluation, such as knee arthritis
- •5.Bone fracture or bone infection at hip under evaluation
- •6.Patients who are candidates for any predictable joint replacement on the hip that is evaluated
- •7.Active hepatitis B (defined as positive HBs Ag and/or positive PCR), active hepatitis C (defined as positive PCR), positive serology for HIV , or Syphilis1, or HTLV-11
- •8.Presence, or previous history, of risks factors for diseases caused by prions, and recipients of grafts of cornea, sclera, and dura mater
- •9.History of blood loss exceeding 450 ml (incl. donations) within 1 month of screening
- •10.Renal impairment defined by an estimated creatinine clearance value < 30 ml per min, calculated with the Cockcroft-Gault formula
- •11.Hepatic impairment, defined as alanine aminotransferase or aspartate aminotransferase = 3 times the upper limit of normal
- •12.Poorly controlled diabetes mellitus, defined as HbA1C > 9%
- •13.Global sepsis
- •14.Allergy to gentamicin or porcine collagen or any substance or device the patient might be exposed to in the context of the study related interventions (i.e., bone marrow harvesting and implantation), as judged by the Investigator
- •15. History of hypersensitivity to human biological material, including blood and blood derived products, documented clinically or by laboratory tests
- •16.Current or past history of solid or haematological neoplasia (except for basal cell carcinoma of the skin and for carcinoma in situ of the cervix that has been treated with no evidence of recurrence)
- •17.History of bone marrow transplantation
- •18.Patients with a life expectancy less than 2 years, as judged by the Investigator
- •19.Patients treated by core decompression of the hip under evaluation within 6 months of screening
- •20.Treatment with doses of prednisolone =15 mg per day (or equivalent) within 1 month from screening, and patients with anticipated needs of daily corticoid doses =15 mg prednisone (or equivalent) in the 6-month period following PREOB®/Placebo implantation
- •21.Illicit drug or alcohol abuse interfering with patient’s ability to understand and comply with study requirements, as judged by the Investigator
- •22.Pregnancy
- •23.Breast-feeding
- •24.Patients unable to undergo MRI, e.g. patients with pace-maker, intra-ocular or intra-cerebral metallic foreign bodies, and mechanical artificial heart valves
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