IRCT20211102052944N2尚未招募2 期
Safety and efficacy evaluation of intra-articular knee transplantation of three consecutive doses of Platelet-Rich Plasma in patients with knee osteoarthritis: Interventional clinical trial, Phase II
Royan Stem Cell Technology Company0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 years 至 70 years（—）
- 性别
- All
入选标准
- •45-70 years
- •Kellgren and Lawrence grade of both knees between 2 and 3
- •knee pain for at least 4 months that has not responded to common medical and physical therapies.
- •Visual analogue score = 4
- •Informed consent
排除标准
- •Pregnancy or lactation
- •Presence of any concomitant knee injury that causes pain or swelling (eg, ligament damage or meniscal tear)
- •Intra-articular injection of hyalgan or steroid drugs during the last 2 months
- •Malalignment of the knee joint more than 15 degrees (diagnosis with triple joint view radiography)
- •Documented uncontrolled underlying diseases (including diabetes (HbA1c = 8), heart failure (EF<45%), kidney failure (Cr>2), liver failure (AST, ALT>100)
- •The existence of blood or cardiovascular diseases, infections and weak immunity, neoplasm, etc., which interfere with the evaluations.
- •History of orthopedic surgery in the spine or lower limbs
- •osteoarthritis of the hip or ankle joint
- •Known allergy to hyaluronic acid products
- •Taking aspirin one week before cell injection
- •History of coagulopathy or use of anticoagulant drugs
研究者
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