Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.
A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis. This is a randomized,single-blind, double-blinded,phase I clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different dosage group after signing the ICF and screening tests.The treatment will accept Allogenic ReJoinTM at the first and fourth week.The duration of the therapy is 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
Biological: Allogenic Adipose tissue-derived mesenchymal progentior 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
Safety, recording of Adverse Events and Serious Adverse Events
Time frame: 12 weeks,48 weeks
WOMAC Score
Time frame: 48 weeks
VAS Score
Time frame: 48 weeks
SF-36
Time frame: 48 Weeks
The volume of articular cartilage
Time frame: 48 weeks
WORMS Score
Time frame: 48 weeks
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