An interventional study of SVF treatment in Knee Osteoarthritis, sponsored by Zhongnan Hospital. Completed at 1 site in China. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Zhongnan Hospital · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Zhongnan Hospital is the lead sponsor of 103 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint
Procedure: SVF treatment
No treatment
autologous SVF (10E8 cells)
Radiologic evaluation of knee articular cartilage Volume
The Volume (cubic millimeter) of knee articular cartilage are measured.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline Lysholm Knee Scale score at 24 weeks.
Plan to share: Yes — All collected IPD, all IPD that underlie results in a publication
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Zhongnan Hospital