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| Name | Class |
|---|---|
| Fifth Affiliated Hospital of Guangzhou Medical University | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.
Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells.
To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hUC-MSC treatment | Experimental | Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human umbilical cord mesenchymal stem cells | Biological | A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic resonance imaging (MRI) of the knee | The size, depth of cartilage defect, and regenerated cartilage were measured using MRI. | Before and 1,3,6,12 month after treatment |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping J Chen, Professor | Fifth Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital Immunotherapy center | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D002357 | Cartilage Diseases |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001168 | Arthritis |
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|
Change in WOMAC pain score,composite score and function and stiffness index scores.
| Before and 1,3,6,12 month after treatment |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |