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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous SVF treatment | Experimental | Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint |
|
| Placebo group | No Intervention | No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SVF treatment | Procedure | autologous SVF (10E8 cells) |
|
| 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]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xin Xiao Zheng, MD | Wuhan University | Principal Investigator |
| Lin Cai, MD | Wuhan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 437200 | China |
All collected IPD, all IPD that underlie results in a publication
starting 6 months after publication
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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. |
| D012216 |
| Rheumatic Diseases |