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
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