Knee Osteoarthritis. Primary gonarthrosis, bilateral
Conditions
Interventions
Intervention 1: Intra-articular injection of 2 mL hyaluronan (scaffold) + 2 mL autologus mesenchymal stem cell (2-3 million) + 0.2 mL dexamethasone. Intervention 2: Intra-articular injection of 2 mL h
Treatment - Drugs
Placebo
Intra-articular injection of 2 mL hyaluronan (scaffold) + 2 mL autologus mesenchymal stem cell (2-3 million) + 0.2 mL dexamethasone
Intra-articular injection of 2 mL hyaluronan (scaffold) + 2 mL autologus platelet rich plasma + 0.2 mL dexamethasone
Intra-articular injection of 2 mL hyaluronan (scaffold) + 2 mL autologus mesenchymal stem cell (2-3 million) + 2 mL autologus platelet rich plasma + 0.2 mL dexamethasone
Sponsors
Immunology Research Center
Headquarter of Research and Application of Stem Cells
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: Female or male patient with knee osteoarthritis based on the ACR criteria and knee radiography; Grade 2 or 3 osteoarthritis according to Kellgren and Lawrence grading scale; 45 < Patient’s Age< 75; Signed informed consent; No consumption of glucocorticoids, anti-inflammatory and immunomodulatory medications one week prior to the treatment; No history of previous participating in clinical trials on treatment of osteoarthritis; No intra-articular injection of hyaluronic acid in the past 6 months EXCLUSION CRITERIA: Secondary osteoarthritis; Concurrent connective tissue disorder; Active neurological disease; Severe cardiac disease; Debilitating respiratory disease requiring constant treatment; Any endocrinopathy; Malignancies; Current infectious disease; Psychologic diseases (especially major depression) requiring treatment with antidepressants or related medications; Being under treatment with immunosuppressive or cytotoxic medications; Being under constant treatment with antithrombotic medications; History of allergy to biologic products; Hb < 11 g/dL; Plt < 120*103/µL
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morphological characteristics of of articular cartilage. Timepoint: Before intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: MRI Osteoarthritis Knee Score (MOAKS).;Pain. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Pain Numerical Scale Rating.;Symptoms and function of the affected knee. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Range of motion. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Angle with protractor. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Jalil Tavakol Afshari
Bu-Ali Research Institute
Outcome results
None listed