Effect of PRP derived from umbilical cord blood in the treatment of knee arthritis
- Conditions
- Knee Osteoarthritis.Osteoarthritis of knee
- Registration Number
- IRCT20211102052944N2
- Lead Sponsor
- Royan Stem Cell Technology Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events and severe adverse events. Timepoint: 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Clinical signs and questionnaire.;Western Ontario and McMaster Universities Osteoarthritis Index. Timepoint: Baseline and 2, 4, 6, 9, and 12 months after intervention. Method of measurement: WOMAC Questionnaire.;Visual analog scale. Timepoint: Baseline and 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Visual Analogue Scale Questionnaire.;Disability index. Timepoint: Baseline and 6, 9, and 12 months after intervention. Method of measurement: Short Form Health-36 Questionnaire.;Articular cartilage thickness. Timepoint: Baseline and 12 months after intervention. Method of measurement: Magnetic resonance imaging.
- Secondary Outcome Measures
Name Time Method Adverse events and severe adverse events. Timepoint: 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Clinical signs and questionnaire.