Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy
A Multicenter, Randomized, Double-blind, Controlled Phase II Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for Knee Osteoarthritis. This is a multicenter, randomized, double-blinded, phase II clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different group after signing the ICF and screening tests. Each group was treated for two cycles. The patients were followed up to 48 weeks after the first treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
106
Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use
No mesenchymal progenitor cells for intra- articular use
China-Japan Friendship Hospital
Beijing, China
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, China
Huashan Hospital Affiliated to Fudan University
Shanghai, China
Shanghai General Hospital
Shanghai, China
WOMAC Score
The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points;96 points mean a worse outcome,will be tested at 24 weeks after the first injection
Time frame: 24 weeks
MRI quantitative analysis of articular cartilage
Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24、48 weeks after the first injection
Time frame: 24 weeks,48 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、8、12、36、48 weeks after the first injection
Time frame: 4、8、12、36、48 weeks
VAS Score
Visual Analogue Scale/Score;0-10 points;10 points mean a worse outcome,will be tested at 4、8、12、24、36、48 weeks after the first injection
Time frame: 4、8、12、24、36、48 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、8、12、24、36、48 weeks after the first injection
Time frame: 4、8、12、24、36、48 weeks
Adverse Events and Serious Adverse Events
AE and SAE, will be assessed at 0d、1、3、4、8、12、24、25、27、28、36、48 weeks
Time frame: 0d、1、3、4、8、12、24、25、27、28、36、48 weeks
Changes of laboratory test indexes and vital signs
Vital signs, physical examination, clinical laboratory tests:infectious disease check, blood coagulation test , blood check, urine check, blood biochemical test, immunological examination, tumor screening ,will be tested at 0d、1、3、4、8、12、24、25、27、28、36、48 weeks
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Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China
Time frame: 0d、1、3、4、8、12、24、25、27、28、36、48 weeks