Mesenchymal Stem Cells In Treatment Of Knee Osteoarthritis
Phase 1
- Conditions
- osteoarthritis.Primary arthrosis NOS
- Registration Number
- IRCT2015101823298N2
- Lead Sponsor
- Vice Chancellor For Research Of Tehran University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
inclusion criteria: knee osteoarthritis based on ACR (American College of Rheumatology) criteria and grade 1,2,3 based on Kellgren-Lawrence grading scale; Ability to follow during the study period
exclusion criteria: age <18 and >75 years; presence of any acute or chronic infectious process; knee deformity (varus >10 ° or valgus >20° ); impaired renal function(creatinine>2.0 mg/dl); impaired liver function(Bilirubin > 2.0 ?/?, AST/ALT > 100 IU/L); Pregnancy or lactating; neoplasia; BMI>35; Immunosuppressive state; Systemic autoimmune rheumatic disease or secondary osteoarthritis; intraarthicular injections in last 3 months; history of knee surgery; Poorly controlled diabetes mellitus
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method KOOS value. Timepoint: before,2 months and 6 months after injection. Method of measurement: KOOS questionnaire.;VAS value. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: VAS.;Knee range of motion. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: goniometer.;Radiologic MRA parameters. Timepoint: before and 6 months after injection. Method of measurement: MRA(magnetic resonance arthrography).
- Secondary Outcome Measures
Name Time Method Clinical sign and symptoms of inflammatory and allergic reactions. Timepoint: before,30 minute,2 weeks,2 months and 6 month after injection. Method of measurement: physical examination(swelling, erythema, skin rash, fever, effusion).