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The purpose of this study is to investigate the efficacy and safety of transplantation of umbilical cord mesenchymal stem cells(UCMSCs) in patient with Knee cartilage damage.
Human cartilage only has limited regenerative potential. Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of ucMSCs does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cell treatment | Experimental | Umbilical Cord Mesenchymal stem cells (UCMSC) expanded and treated for 1-2 weeks. Then administer 5x10^6 of UCMSC per cm^2 of the cartilage defect. |
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| Hyaluronic acid treatment | Active Comparator | Administer hyaluronic acid (30 mg) in a single injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord mesenchymal stem cells | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Function Change and Improvement | Knee assessments will be performed using the following tools: Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 12 months after treatment |
| Knee Function Change and Improvement | Changes in knee function will be assessed via the IKDC score. | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of adverse events | Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuetao Pei, M.D.,Ph.D | Contact | 8610-68164807 | AMMS0906@163.COM | |
| Hailei Yao, Ph.D | Contact | 8620-89199000 | yaohailei@scrm.org.cn |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| Hyaluronic acid |
| Device |
|