Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint

Study Overview
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Brief Summary
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Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in vitro and may regenerate several damaged or injured tissues. In addition its has demonstrated that MSC are able to modulate immune responses and to control inflammation through its action on T lymphocytes. Preliminary studies in animal models, including one carried out in an equine by the investigators research group, confirms feasibility, safety and efficacy evidence proposed treatment protocol.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.

Detailed Description
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Mesenchymal stem cells are pluripotent cells that can be obtained from various tissues .They have shown capabilities to differentiate into bone,cartilage,muscle,and adipose tissue, representing a new clinical strategy in regenerative medicine.An increasing number of reports have demonstrated effectiveness of percutaneous intra-articular infusion of MSCs in arthritic disease. In this study we perform a single intra articular injection of cultured mesenchymal stem cells in patients suffering from osteoarthritis, with the aim to assess its clinical safety and efficacy.Patients are assessed for response with MRI, X-Ray examination, WOMAC osteoarthritis index,VAS, and SF36 2,4,8 weeks and 6, and 12 months post infusion.

Official Title
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Mesenchymal Stem Cells Transplantation for Articular Cartilage Resurfacing in Patient With Osteoarthritis of Knee Joint

Conditions
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Osteoarthritis

Intervention / Treatment
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* Biological: Mesenchymal Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients not pregnant or lactating. Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior cell therapy Marcaine 0.75% و Lidocaine 4% test performed to be assure the exact location of the pain is related to the knee. Diagnosis must be based on magnetic resonance imaging. Both genders Age:18-65 years Exclusion Criteria: Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease. Known allergic reaction to components of study treatment and/or study injection procedure Patients infected with hepatitis B,C or HIV.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal Injection<br>Intra Articular injection in Patients with osteoarthritis of knee joint | Biological: Mesenchymal Injection<br>* Intra Articular Injection of Mesenchymal cells to the knee joint<br>* Other names: Cell Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | evaluation the effect of Mesenchymal stem cell transplantation to decrease the patients pain | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | decrease the patient pain in VAS scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesenchymal cells, osteoarthritis, intra articular injection