IRCT20211102052944N2Not yet recruitingPhase 2
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 sites30 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 45 years to 70 years (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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