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| Name | Class |
|---|---|
| Chinese Academy of Sciences | OTHER_GOV |
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human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury, and observe the safety of the cells for meniscus injury
Three different dosage of human embryonic stem cell derived mesenchymal stem cells like for meniscus injury patients, and observe the safety of the cells for meniscus injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meniscus Injured patients | Experimental | hESC Derived MSC Like Cell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hESC derived MSC like cell | Biological | Different dosage of hESC derived MSC like cell for the meniscus injured patients |
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| Measure | Description | Time Frame |
|---|---|---|
| The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events | Adverse events include:allergic reactions, local reactions or infections at the injection site and muscle or skeletal dysplasia | 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound of knee joint | Ultrasound of knee joint | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell |
| Visual Analog Score for pain(VAS) | VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective pain. The scale range is from 0 to 10, the higher the score, the more severe the pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Chen, Doctor | Wuhan TongJi Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College of Science and Technology | Wuhan | Hubei | 430030 | China |
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| baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell |
| Range of knee motion | to use the goniometer to measure the range of knee motion | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell |
| Lysholm Knee Scale | The scale is to assess the function of knee. The scale range is from 0 to 100, the higher the score, the more severe the knee problems. This scale includes 8 items, and the total score is the sum of these 8 items' scores. Individual items are scored differently, using individual scoring scales: 1. limp (0,3,5), 2. support (0,2,5), 3. locking (0,2,6,10,15), 4. instability (0,5,10,15,20,25), 5. pain (0,5,10,15,20,25), 6. swelling (0,2,6,10), 7. stair climbing (0,2,6,10), 8. squatting (0,2,4,5). | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell |
| MRI of knee | MRI of knee | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell |
| Global posture analysis system | to test the static balance | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell |
| Dynamic balance test | Use the dynamic posture evaluator | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell |