The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis

Study Overview
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Brief Summary
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Osteoarthritis of the knee is one of the most common causes of disability among elderly. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow Mesenchymal Stem Cells (MSC) and stromal Vascular Fraction (SVF) in patients with severe knee osteoarthritis

Detailed Description
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This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal Stem Cells will be isolated from bone marrow and stromal Vascular Fraction fram lipoaspirate, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale

Official Title
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Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells and Stromal Vascular Fraction Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial

Conditions
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Osteoarthritis

Intervention / Treatment
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* Biological: Mesenchymal stem cell
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis diagnosed by MRI Exclusion Criteria: Pregnancy or lactating Positive tests for HIV, Hepatitis C virus (HCV), Hepatitis C virus (HBV) Active neurologic disorder End organ damage Uncontrolled endocrine disorder

Ages Eligible for Study
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Minimum Age: 25 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cell<br>Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection | Biological: Mesenchymal stem cell<br>* intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation<br>|
| Experimental: placebo<br>The patients who are in control group and underwent placebo injection | Biological: Placebo<br>* Patients with knee joint osteoarthritis who underwent intra articular placebo injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function improvement | Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection | 2 weeks | 
| Change in pain density | Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint swelling | Evaluation the joint swelling by physical examination after intra articular cell injection | 3 months | 
| Joint erythema | Evaluation the joint erythema by physical examination after cell injection | 3 months | 
| Deterioration of joint function | Evaluation the deterioration of joint function by physical examination after intra articular cell injection | 3 months | 
| Allergic reactions | Evaluation the allergic reactions like skin rash,skin erythema, dyspnea by physical examination after cell injection | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Joint Diseases, Musculoskeletal Diseases, Arthritis