EUCTR2009-012929-11-DE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 118 人开始时间: 2011年12月22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
- 118
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
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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
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
- •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.Blood not qualifying for PREOB® production, including active hepatitis
- •B (defined as positive HBs Ag and/or positive PCR), or active hepatitis C
- •(defined as positive PCR), positive serology for HIV, or Syphilis, or HTLV-
- •1, and any other tests that may be required by the authorities in case of
- •a new disease outbreak that can affect the safety of the physicians and
- •operators at the time of patient screening.
- •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 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 interferin
研究者
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