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临床试验/EUCTR2016-004755-75-FR
EUCTR2016-004755-75-FR进行中(未招募)1 期

Intra articular injection of microfat and platelet-rich plasma in the treatment of knee osteoarthritis : a pilot study - MICROPREP

Clinique Juge0 个研究点目标入组 30 人开始时间: 2017年2月20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

入选标准

  • 1. Males and females between 20 to 65 years of age
  • 2. Symptomatic knee osteoarthritis , ICRS grade 2, 3 ou 4
  • 3. BMI between 20 to 30
  • 4. Written informed consent, signed by patient or legal representative
  • (if patient unable to sign).
  • 5.HB > 10g/dl
  • 6.Negative pregnancy test
  • 7.Social security affiliated
  • 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 0

排除标准

  • 1.IRM contre-indications: ocular loose bodies, pace maker, neurostimulateur, cochlear implant, vascular clips, mettalic cardiac valve
  • 2.BMI < 20
  • 3.Thrombocytopenia < 150 G/L
  • 4.Thrombocytosis > 450 G/L
  • 5.Thrombopathy
  • 6.TP < 70%
  • 7.TCA patient / witness rapport > 1,20
  • 8.Anaemia: HB < 10g/dl
  • 9. Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
  • 10.Treatment by platelet inhibiting agent, aspirin, anti vitamin K completed more than 2 weeks before inclusion
  • 11.Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion
  • 12.Intra articular knee injection of corticosteroid more than 8 weeks before inclusion
  • 13.Intra articular knee injection of hyaluronic acid more than 8 weeks before inclusion
  • 14.NSAI treatment completed more than 2 weeks before inclusion
  • 15.Fever or recent disease
  • 16.Auto immune disease
  • 17.Inflammatory Arthritis
  • 18.Immune deficit
  • 19.Infectious disease
  • 20.Malignant tumor being treated or history of malignant tumor

研究者

发起方
Clinique Juge

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