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Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Intraarticular injection of 2×10~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml) |
|
| Control group | Other | Intraarticular injection of hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical-cord mesenchymal stromal cells (UC-MSCs) | Biological | Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in visual analogue scale (VAS) | Visual analogue scale (VAS) | Baseline, 1, 3, 6 and 12 weeks |
| Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score | WOMAC | Baseline, 1, 3, 6 and 12 weeks |
| Change From Baseline in knee society score (KSS) | knee society score (KSS) | Baseline, 1, 3, 6 and 12 weeks |
| Change From Baseline in MOS item short from health survey(SF-36) | The MOS item short from health survey(SF-36) | Baseline, 1, 3, 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI | Baseline, 1, 3, 6 and 12 weeks | |
| The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid | The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changhui Zhou, Ph.D. | Contact | 86-0635-8272202 | zhouchanghui008@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dawang Wang, Ph.D. | Liaocheng People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaocheng city people's hospital | Recruiting | Liaocheng | Shandong | 0635 | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Hyaluronic acid | Other | intra-articular injection of Hyaluronic Acid |
|
| Baseline, 1, 3, 6 and 12 weeks |