Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.
Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
Shanghai, Shanghai Municipality, China
Recording of Adverse Events and Serious Adverse Events
Time frame: 12 weeks
Electrocardiogram
Time frame: 9 weeks
Vital signs
Time frame: 9 weeks
Physical examination
Time frame: 9 weeks
WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: 24 months
Laboratory tests
Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests
Time frame: 9 weeks
SF-36
Time frame: 24 months
NRS-11
Time frame: 24 months
The volume of articular cartilage
Time frame: 24 months
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