Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
520
Allogenic adipose tissue-derived mesenchymal stem cells administrated for intra- articular use
Sodium Hyaluronate administrated for intra-articular use
RenJi Hospital
Shanghai, China, China
RECRUITINGShanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
NOT_YET_RECRUITINGWOMAC score
The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points;96 points mean a worse outcome,will be tested at 48 weeks after the first injection
Time frame: 48 weeks
MRI quantitative analysis of articular cartilage
Time frame: 24 weeks
WOMAC Score
The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points;96 points mean a worse outcome, will be tested at 4、12、24、36、60、72、84 and 104 weeks after the first injection
Time frame: 4、12、24、36、60、72、84 and 104 weeks
MRI quantitative analysis of articular cartilage (volume change percentage)
Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 12、48、104 weeks after the first injection
Time frame: 12、48、104 weeks
MRI quantitative analysis of articular cartilage (volume change)
Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 12、24、 48 and 104 weeks after the first injection
Time frame: 12、24、 48 and 104 weeks
VAS Score
Visual Analogue Scale/Score;0-10 points;10 points mean the worse outcome,will be tested at 4、12、24、36、48、60、72、84 and 104 weeks after the first injection
Time frame: 4、12、24、36、48、60、72、84、104 weeks
SF-36
The Medical Outcomes Study 36-Item Short-Form Health Survey;0-100 points;100 points mean a better outcome, will be tested at 4、12、24、36、48、60、72、84 and 104 weeks after the first injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4、12、24、36、48、60、72、84、104 weeks
Whole-Organ Magnetic Resonance Imaging Score
Whole-Organ Magnetic Resonance Imaging Score(WORMS) of the knee; 0-332points; 332 points means the worst outcome; will be assessed at 12、24、48 and104 weeks
Time frame: 12、24、48 and 104 weeks
mJSW
Minimum joint space width (mJSW) of the knee, will be measured at baseline and 104 weeks
Time frame: 104 weeks
Physical examination
Height and weight will be tested and combined to report BMI in kg/m\^2at Day 0 and week 1、2、3、4、12、24、36、48、60、72、84、104 weeks
Time frame: Day 0、week 1、2、3、4、12、24、36、48、60、72、84、104 weeks
Adverse Events and Serious Adverse Events
AE and SAE, will be assessed within the 104 week time span
Time frame: Day 0 to 104 weeks