跳至主要内容
临床试验/EUCTR2017-000623-27-ES
EUCTR2017-000623-27-ES进行中(未招募)1 期

Role of autologous biological therapy in knee osteoarthritis. Intraosseous application of plasma rich in growth factors , improve of functional capacity and pain, compared to intraarticular application.

Fundacion para la investigacion biomedica HUPA0 个研究点开始时间: 2017年6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

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

  • Age between 40 and 75.
  • Both genders.
  • Moderate to several pain and symptoms according to the KOOS scale of more than 6 months of evolution.
  • Grade III- IV knee osteoathritis according to radiological criteria for the classification of Kellgren and Lawrence.
  • Patients with no response to other pharmacological treatments.
  • Able to fulfill the schedule of visits of the trial.
  • BMI less than 35.
  • 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 86
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 48

排除标准

  • Intraarticular infiltration with plasma rich in growth factors in the 12 months before the inclusion
  • Intraarticular infiltration with hyaluronic acid in the 6 months before the inclusion.
  • Angular alterations, higher than 15 degrees and unstable joint.
  • Systemic or local infectious disease and polyarticular disease.
  • Cancer under treatment or under follow-up.
  • Immunosuppressive treatment or systemic autoimmune disease.
  • Patient with hypertension or diabetes mellitus poorly controlled.
  • Allergy to some study drugs or excipients.
  • Patients on anticoagulants or antiplatelet therapy which cannot be reversed temporarily for infiltrations.
  • Positive to sifilis, hepatitis B, hepatitis C or VIH+.
  • Uncapable to understand or fulfill the questionnaries of the study.

研究者

发起方
Fundacion para la investigacion biomedica HUPA

相似试验