Knee Osteoarthritis. Osteoarthritis of knee
Conditions
Interventions
Intervention 1: Control group: Patients receiving 3 doses of normal saline + Hyaluronic acid
Sponsors
Royan Stem Cell Technology Company
Cell-Tech Pharmed
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 40-70 years Unilateral knee osteoarthritis Kellgren and Lawrence grade of both knees between 2 and 3 Evidence of x-ray imaging findings compatible with knee osteoarthritis 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
Exclusion criteria: Pregnancy or lactation Inflammatory or infectious arthritis Intra-articular injection during the last 2 months Body Mass Index = 35 Haematological and biochemical analysis with significant alterations that contraindicates intervention Known and uncontrolled chronic disease (including diabetes (HbA1c = 8), heart failure (EF 2), liver failure (AST, ALT> 100) History of any type of neoplasm Take aspirin one week before the cell injection History of coagulopathy or use of anticoagulants Positive viral tests (HIV, CMV, HTLV1 & 2, HBV, HCV) Having a movement disorder Having serious illnesses with a life expectancy of less than 1 year Drug or alcohol abuse History or clinical diagnosis of any psychological disorder Arthroscopy in the last 6 months Rheumatoid arthritis or other autoimmune diseases that affect the joints. Immunosuppression or taking systemic immunosuppressant Allergy to proteins or substances in culture medium (gentamicin, bovine or equine serum) History of corticosteroid use 3 months before enrolment Knee joint misalignment =15 degree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and severe adverse events. Timepoint: 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Clinical signs and questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analog scale. Timepoint: Baseline and 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Visual Analogue Scale 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.;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 6, 9, and 12 months after intervention. Method of measurement: Magnetic resonance imaging. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMorteza Zarrabi
Royan Institute
Outcome results
None listed