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The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).
This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stem Cells from adipose | Experimental | Mesenchymal Stem Cells from adipose will be injected. |
|
| hyaluronic acid | Active Comparator | Hyaluronic acid will be injectied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem Cells from adipose | Biological | inject mesenchymal Stem Cells from adipose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unexplained local and systemic symptoms or death | The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:â‘ not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); â‘¡related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; â‘¢it can't be assessed. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| VAS score | VAS score decrease 3 points or more | 2 years |
| WOMAC score | two or more terms of WOMAC score have improvement. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziyi Yang, MD | Contact | 18810335110 | bjmuyangziyi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ziyi Yang | arthritis clinic and research center | Principal Investigator |
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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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| Hyaluronic Acid | Biological | inject hyaluronic acid |
|
| D012216 |
| Rheumatic Diseases |