A Phase 2 interventional study of Mesenchymal progenitor cells and No mesenchymal progenitor cells in Knee Osteoarthritis, sponsored by Shanghai AbelZeta Ltd.. Completed at 7 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Shanghai AbelZeta Ltd. · Phase 2, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 106 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Shanghai AbelZeta Ltd. is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
24.The Kellgren Lawrence grade (X-ray axial position of knee joint) of any knee joint of the subjects was grade IV.
Mesenchymal progenitor cells low-dose group
Biological: Mesenchymal progenitor cells
Mesenchymal progenitor cells high-dose group
Biological: Mesenchymal progenitor cells
No mesenchymal progenitor cells
Biological: No mesenchymal progenitor cells
Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use
No mesenchymal progenitor cells for intra- articular use
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
Time frame: 0d、1、3、4、8、12、24、25、27、28、36、48 weeks
Metabolic index detection
Levels of cartilage metabolism and inflammatory biomarkers in serum and urine will be tested at 0、4、8、12、24、36、48 weeks
Time frame: 0、4、8、12、24、36、48 weeks
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Shanghai AbelZeta Ltd.