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临床试验/NCT04352075
NCT04352075已完成1 期

Intra Articular Injection of Autologous Microfat and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: a Pilot Study

Clinique Juge1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Cartilage relaxation time on MRI T2-mapping at 3 months

研究概览

简要总结

The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment.

详细描述

Osteoarthritis is the most common joint disease in the world and one of the most common causes of pain and functional disability. The incidence of cartilage pathology has grown due to the ageing population, and the increase in sports participation and its associated trauma. The treatment of these cartilage damage is limited and remains a major public health issue.

The aim of the medical treatment and intra articular injections consists in reducing pain and improving the knee function in order to limit the sport, professional and social negative impact in the youngest patients. Nevertheless their efficacy remain non predictable in patients.

The arthroplasty will be proposed in the final intention. Insofar arthroplasty is a surgical procedure 1 / which presents a potential infectious risk associated with its invasive nature, 2 / it requires iterative revision surgery, especially in young patients given the limited lifetime of the implants and 3 / whose complete postoperative recovery take several months, it seems justified to continue studies to validate effective alternative treatments to delay the use of joint replacements.

Recently, the emergence of biotherapy in orthopedics has developed the use of intra-articular injections of platelet-rich plasma (PRP). Their use has increased substantially and is based on the demonstration that platelet-rich plasma concentrate growth factors, can stimulate cartilage regeneration in vitro and in vivo preclinical models. In humans, recent data from the literature show that these autologous products are very well tolerated. Their scientific evaluation remains difficult in that 1 / indications and surgical procedures are not harmonized 2 / manufacturing processes PRP are not standardized 3 / quantitative and qualitative composition of PRP is rarely documented.

PRP administration procedures can be optimized: indeed in that, it is a liquid preparation (platelet suspension), its administration in a interface tissue allows to limit its spread and potentiate its trophic effect on the injured cartilage site. Adipose tissue is the most relevant interface tissue given, because it's a tissue rich in stem cells with full therapeutic potential and is easily accessible by subcutaneous minimally invasive procedure. Thus, autologous microfat (fat removed under local anesthesia by manual liposuction using fine cannulas specific) administered in the synovial capsule, could play the matrix to receive the injection of PRP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females between 20 to 65 years of age
  • Symptomatic knee osteoarthritis , ICRS grade 2, 3 ou 4 with VAS > 4 and failure of medical treatment for at least one year
  • BMI between 20 to 30
  • Written informed consent, signed by patient or legal representative
  • HB > 10g/dl
  • Negative pregnancy test
  • Social security affiliated

排除标准

  • IRM contre-indications: ocular loose bodies, pace maker, neurostimulateur, cochlear implant, vascular clips, mettalic cardiac valve
  • BMI < 20
  • Thrombocytopenia < 150 G/L
  • Thrombocytosis > 450 G/L
  • Thrombopathy
  • TP < 70%
  • TCA patient / witness rapport > 1,20
  • Anaemia: 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, anti vitamin 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 knee injection of corticosteroid more than 8 weeks before inclusion
  • Intra articular knee injection of hyaluronic acid more than 8 weeks before inclusion
  • NSAI treatment completed more than 2 weeks before inclusion
  • Fever or recent disease
  • Auto immune disease
  • Inflammatory Arthritis
  • Immune deficit
  • Infectious disease
  • Malignant tumor being treated or history of malignant tumor

研究组 & 干预措施

Microfat + PRP 3M platelets

Experimental

microfat (5 ml) associated with PRP with a dose of 3 billions of platelets (5 ml)

干预措施: Autologous biologic drug of innovative therapy /cell therapy drug (Drug)

Microfat + PRP 1M platelets

Experimental

microfat (5 ml) associated with PRP with a dose of 1 billion of platelets (5 ml)

干预措施: Autologous biologic drug of innovative therapy /cell therapy drug (Drug)

Microfat

Experimental

microfat (5 ml) and saline solution (5 ml)

干预措施: Autologous biologic drug of innovative therapy /cell therapy drug (Drug)

结局指标

主要结局

Cartilage relaxation time on MRI T2-mapping at 3 months

时间窗: Baseline and 3 months post injection

The primary objective of this study is to demonstrate the efficacy of intra-articular injection of autologous microfat associated with a standardized preparation of autologous PRP, by changes in the cartilage relaxation time on MRI T2-mapping at 3 months.

次要结局

  • Improved of chondral lesion on MRI(Baseline and 3 and 6 months post injection)
  • Responding patients(Baseline and 3 and 6 months post injection)
  • Biologic parameters / clinical efficacity(Baseline and 3 and 6 months post injection)
  • Pain(Baseline and 1 and 3 and 6 months post injection)
  • WOMAC(Baseline and 1 and 3 and 6 months post injection)

研究者

发起方
Clinique Juge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie-Laure LOUIS

Principal investigator

Clinique Juge

研究点 (1)

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