SVF Therapy for Human Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.

Detailed Description
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Study participants voluntarily provided written informed consent to participate in the study. The two knees of each patient were randomly assigned to autologous SVF treatment group or non-treatment control group. The patients were evaluated every 4 weeks for safety and efficacy of autologous SVF therapy for 24 weeks.

Official Title
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Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: SVF treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Knee Osteoarthritis Articular cartilage defect grades I/II of both knee Exclusion Criteria: autoimmune or inflammatory arthritis serious medical disorders

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous SVF treatment<br>Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint | Procedure: SVF treatment<br>* autologous SVF (10E8 cells)<br>|
| No Intervention: Placebo group<br>No treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologic evaluation of knee articular cartilage Volume | The Volume (cubic millimeter) of knee articular cartilage are measured. | Change from Baseline articular cartilage Volume at 12 weeks | 
| Radiologic evaluation of knee articular cartilage Volume | The Volume (cubic millimeter) of knee articular cartilage are measured. | Change from Baseline articular cartilage Volume at 24 weeks | 
| Radiologic evaluation of knee articular cartilage Area | The Area (square millimeter) of knee articular cartilage are measured. | Change from Baseline articular cartilage Area at 12 weeks | 
| Radiologic evaluation of knee articular cartilage Area | The Area (square millimeter) of knee articular cartilage are measured. | Change from Baseline articular cartilage Area at 24 weeks | 
| Radiologic evaluation of knee articular cartilage Thickness | The Thickness (millimeter) of knee articular cartilage are measured. | Change from Baseline articular cartilage Thickness at 12 weeks | 
| Radiologic evaluation of knee articular cartilage Thickness | The Thickness (millimeter) of knee articular cartilage are measured. | Change from Baseline articular cartilage Thickness at 24 weeks | 
| Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC]) | Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome. | Change from Baseline WOMAC arthritis index score at 12 weeks. | 
| Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC]) | Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome. | Change from Baseline WOMAC arthritis index score at 24 weeks. | 
| Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale) | The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome. | Change from Baseline Lysholm Knee Scale score at 12 weeks. | 
| Knee pain evaluation and functional evaluation (The Lysholm Knee Scale) | The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome. | Change from Baseline Lysholm Knee Scale score at 24 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cartilage Defect, Cartilage Regeneration