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Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cells | Experimental |
| |
| Sodium hyaluronate | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem Cells | Drug | Allogenic adipose tissue-derived mesenchymal stem cells administrated for intra- articular use |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC 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 | 48 weeks |
| MRI quantitative analysis of articular cartilage | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4、12、24、36、60、72、84 and 104 weeks |
| MRI quantitative analysis of articular cartilage (volume change percentage) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital | Recruiting | Shanghai | China | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Sodium Hyaluronate Injection | Drug | Sodium Hyaluronate administrated for intra-articular use |
|
Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 12、48、104 weeks after the first injection |
| 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 | 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 | 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 | 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 | 12、24、48 and 104 weeks |
| mJSW | Minimum joint space width (mJSW) of the knee, will be measured at baseline and 104 weeks | 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 | 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 | Day 0 to 104 weeks |
| Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | China |
|
| D012216 |
| Rheumatic Diseases |