RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA Knee): (MSC)
Osteoarthritis, Knee
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects aged between 18 and < 65
- Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3
- Patients on a pain level equal to or higher than 5 on a VAS scale of 10
Exclusion Criteria:
- Previous cases of alcoholism or drug abuse
- Pregnancy and breast-feeding
- Serious pathologies such as carcinoma or autoimmune disease
- Hypersensitivity toward Hyaluorinc Acid
- Undergoing steroid-based systemic therapy or interrupted since less than 1 month
- Significant hematologic diseases
- Mechanical instability, ligamentous laxity/deficiency or gross deformity
Sites / Locations
- Department of Orthopaedics & Traumatology
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Autologous Mesenchymal Stem Cells Treatment (MSCs)
Hyaluronic acid (HA)
The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee. The treatment will be carried out after the patient has received a blood test and clinically evaluated at T0. T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)
The patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be purchased for the patient from the manufacturer or from the pharmacy of the hospital.The intra-articular injection will be carried out after the patient has received a clinical evaluation at T0. T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)