RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA Knee):

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the therapeutic effect of adult autologous mesenchymal stem cells (abbreviated as MSCs) in patients with osteoarthritic knee and compare to intra articular injection of Synvisc-One.

Detailed Description
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Study Participants: This study will involve patients affected by osteoarthritis who comply with the inclusion and exclusion criteria. 30 patients, between the age of 18 and <65, will be enrolled in the study and randomized into three groups to receive either an injection of MSCs, hyaluronic acid (HA) or no injection. Type of Study: This is a randomized control study. Treatment method: Each patient will randomly be assigned to one of the following treatment groups: Group A) Mesenchymal stem cells (MSCs) Group B) Hyaluronic acid (HA) Group C) No injection Treatment: Group A) Autologous Mesenchymal Stem Cells Treatment (MSCs) 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) Group B) Hyaluronic acid (HA) 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)

Official Title
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A Randomized Control Clinical Trial to Evaluate the Efficacy of Intra-articular Injections of Mesenchymal Stem Cells Versus Hyaluronic Acid in Patients Affected by Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs)
* Drug: Hyaluronic acid (HA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Mesenchymal Stem Cells Treatment (MSCs)<br>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) | Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs)<br>* The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.<br>|
| Active Comparator: Hyaluronic acid (HA)<br>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) | Drug: Hyaluronic acid (HA)<br>* The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | Clinical Questionnaire Assessment Tool. Score 80-100 = Excellent, Score 70-79 = Good, Score 60-69 = Fair, Score below 60 = Poor | One year | 
| Knee Society Function Score | Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome. | One year | 
| Magnetic resonance image (MRI) and X-ray assessment | Radiological assessment of the knee joint | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life score (HRQoL) - SF36 | Questionnaire Assessment | One year | 
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) | Questionnaire Assessment | One year | 
| Visual Analogic Scale (VAS) pain evaluation | Questionnaire Assessment | One year |