Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.

Official Title
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Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs)
* Other: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30-70 years old. No serious infection, chronic diseases, diabetes and tuberculosis. Osteoarthritis of the knee with grade1-3 defined by the modified Kellgren-Lawrence classification. Written informed consents were obtained from all subjects. Exclusion Criteria: Pregnant women or cognitively impaired adults. Inflammatory or post infectious arthritis. Intra-articular drug injection within the previous 2 months. Serious medical illness with a life expectancy of less than 1 year. Prior admission for substance abuse. Arthroscopy during the previous 6 months. Systemic autoimmune rheumatic disease. Poorly controlled diabetes mellitus. Immunosuppressive or anticoagulant treatments. Treatment with corticosteroids in the 3 months prior to inclusion in the study. NSAID therapy within 15 days prior to inclusion in the study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intraarticular injection of 2×10 7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml) | Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs)<br>* Allogeneic UC-MSCs 1 x 10 7 diluted on 5 mL of Platelet Rich Plasma<br>|
| Other: Control group<br>Intraarticular injection of hyaluronic acid | Other: Hyaluronic acid<br>* intra-articular injection of Hyaluronic Acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in visual analogue scale (VAS) | Visual analogue scale (VAS) | Baseline, 1, 3, 6 and 12 weeks | 
| Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score | WOMAC | Baseline, 1, 3, 6 and 12 weeks | 
| Change From Baseline in knee society score (KSS) | knee society score (KSS) | Baseline, 1, 3, 6 and 12 weeks | 
| Change From Baseline in MOS item short from health survey(SF-36) | The MOS item short from health survey(SF-36) | Baseline, 1, 3, 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI |  | Baseline, 1, 3, 6 and 12 weeks | 
| The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid | The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid | Baseline, 1, 3, 6 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis (OA), mesenchymal stem cells(MSC)