Treatment of Knee Osteoarthritis (KOA) by Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) Into Joint Cavity

Study Overview
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Brief Summary
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The purpose of this study was to analyze and study the efficacy and safety of autologous adipose-derived vascular matrix components (SVF) in patients with knee osteoarthritis before and after treatment through clinical evaluation, radiation index, and metabolic index comparison between plasma and irrigation solution before and after SVF injection.

Official Title
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Clinical Study on the Safety and Efficacy of Intrarticular Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) in the Treatment of Knee Osteoarthritis (KOA)

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Stromal vascular fraction,SVF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age range is 20-70 years old Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower The physical health status is mainly in the ASA grade Ⅰ, Ⅱ and Ⅲ Subjects had no active tumors, no active inflammation, no treponema pallidum, HIV, hepatitis B virus, or hepatitis C virus The subject shall provide the physical examination report of knee X-ray examination, MRI examination and other items Exclusion Criteria: Patients with nonunion or displaced fractures around defective cartilage Pregnant or lactating women Autoimmune disease Subjects with diabetes (exceptions are patients whose blood sugar levels remain within the normal range and diabetes has not caused other complications) The patients had severe neurological diseases affecting the evaluation of postoperative results

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage of arthritis<br>Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower | Behavioral: Stromal vascular fraction,SVF<br>* SVF was injected into the knee cavity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T2 mapping | The degree of change of articular cartilage was observed | 24 months after the first SVF injection into the knee cavity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | The WOMAC is a specific assessment scale for osteoarthritis, which is assessed according to three aspects: pain, stiffness and function. A total of 24 WOMAC scores were scored, 0-10 points for each item, with a total score of 240 points. A total score <80 was mild OA, a total score of 80-120 was moderate OA, and a total score of >120 was severe OA.The severity and therapeutic effect of arthritis were evaluated according to the relevant symptoms and signs of patients. | 24 months after the first SVF injection into the knee cavity | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stromal vascular fraction