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临床试验/EUCTR2016-002648-18-FR
EUCTR2016-002648-18-FR进行中(未招募)1 期

EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA” - AMIPREP

ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE0 个研究点目标入组 12 人开始时间: 2019年11月25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
12

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

  • -Males and females between 20 and 75 years of age
  • -Symptomatic radio-carpal osteoarthritis diagnosed by arthroscanner resistant to medical treatment and candidate to surgery
  • -BMI = 20 Kg/m²
  • -Written informed consent, signed by patient or legal representative (if patient unable to sign).
  • -HB > 10g/dl
  • -Negative pregnancy test and efficiency contraception
  • 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 8
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 4

排除标准

  • -Thrombocytopenia < 150 G/L, Thrombocytosis > 450 G/L, Thrombopathy
  • -TP < 70%, TCA patient / witness rapport > 1,20
  • -Anemia: HB < 10g/dl
  • -Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
  • -Treatment by platelet inhibiting agent, aspirin, antivitamin K completed more than 2 weeks before inclusion
  • -Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion
  • -Intra articular injection of corticosteroid or hyaluronic acid completed more than 8 weeks before inclusion
  • -NSAI treatment completed more than 2 weeks before inclusion
  • -Fever or recent disease completed more than 1 month before inclusion
  • -Auto immune disease, Inflammatory or microcrystalline Arthritis, Immune deficit
  • -Infectious disease
  • -IRM contraindication: ocular loose bodies, pace maker, neurostimulator, cochlear implant, vascular clips, metallic cardiac val
  • -Anesthesia or surgery contra indication, iodine allergy

研究者

发起方
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

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