it's a self-control, double blind study of autologous adipose-derived stromal vascular fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study.
The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 2 ml saline, with at least 50 million nucleated SVF cells and a mean viability of 85%, injected per single knee and the other knee treated with placebo. Cell suspension and placebo will be injected using ultrasound guidance. Safety and knee function will be evaluated by questionaires monthly and MRI in every three months post-op.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
SVF will be obtained from lipoaspirates of subjects which will contain more than 5 millions nucleated cells.
a Placebo treatment without SVF cells
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Incidence of Treatment-Emergent Adverse Events
Subjects will be monitored for adverse events
Time frame: 6 months
Change in Pain Scores on the WOMAC Scale at All Follow-up Visits
Patients outcomes for pain will be scored through questionaires
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Change in Function Scores on the WOMAC Scale at All Follow-up Visits
Patients outcomes for knee function will be scored through questionaires
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Change from baseline in MRI imaging
Knee function will be assessed by MRI at three time points: pre-op, 3 months and 6 months post-op
Time frame: 3 months & 6 months
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