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
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