The effect of mesenchymal stem cells on osteoarthritis recovery
- Conditions
- Osteoarthritis.Osteoarthritis of knee
- Registration Number
- IRCT20210103049925N1
- Lead Sponsor
- Celltech Pharmed Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Knee osteoarthritis (OA) (grade 2 & 3 Kellgren Lawrence scale)
Radiography indicative of knee and femur malalignment of less than 30 degree
Pain level of 4-7 measured in visual analog scale (VAS) 24 hours prior to referral
Age range of 40-65 years
Female/Male
Given informed consent
Inflammatory disorders
Metabolic disorders (e.g : diabetes mellitus)
Autoimmune diseases
Immunodeficiency
Cancer or other severe diseases
Contagious viral infections
Psychological disorders
History of renal or hepatic failure
Body mass index (BMI) >30
Fever
Oral corticosteroids in the last 4 weeks
Injection of corticosteroids in the last 6 months
History of protein or other related allergies
Coagulation disorders
Pregnancy or planning for pregnancy in the last 12 months
Participating in other clinical trials at the same time
Septic arthritis
Addiction to opium, alcohol, painkillers, and/or anesthetics
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ysholm score. Timepoint: 3 months post injection. Method of measurement: Lysholm questionnaire.;International Knee Documentation Committee score. Timepoint: 3 months post injection. Method of measurement: International Knee Documentation Committee (IKDC) Questionnaire.;Disability index. Timepoint: 3 months post injection. Method of measurement: Health Assessment Questionnaire.;Pain index. Timepoint: 3 months post injection. Method of measurement: Visual Analogue Scale questionnaire.;Cartilage thickness. Timepoint: 3 months post injection. Method of measurement: Magnetic resonance imaging.;Range of motion. Timepoint: 3 months post injection. Method of measurement: Goniometer.;Walking distance in six minutes. Timepoint: 3 months post injection. Method of measurement: Meter.
- Secondary Outcome Measures
Name Time Method Side effects. Timepoint: 3 months post injection. Method of measurement: Clinical symptoms, questionnaire, peripheral blood and urine samples.