Safety Observation on hESC Derived MSC Like Cell for the Meniscus Injury

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Safety Observation on Human Embryonic Stem Cell (hESC) Derived Mesenchymal Stem Cells(MSC) Like Cell for the Meniscus Injury

Conditions
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Meniscus Injury

Intervention / Treatment
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* Biological: hESC derived MSC like cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade Ⅰ-Ⅱ meniscus injury of knee joint The patients who still have the pain of knee joint and/or limitation of the function after accepted 3 months of nonoperative treatment Exclusion Criteria: Recent history of lower limb fractures or intra-articular drug injection The patients who have meniscus injury of knee joint need the surgical repair The patients who have the severe coagulation disorders, cardiopulmonary failure and so on The women who are pregnant or nursing There are electronic implants such as pacemakers in the body The patients who are infected the HIV, the virus of hepatitis or syphilis The patients who are alcoholism or drug user The patients who have vestibular and balance disorders The patients with severe cognitive impairment who cannot follow instructions to complete the treatment The patients who don't sign the informed consent The patients who have tumor Immunodeficiency patients The patients who have congenital or acquired knee malformation Patients or researchers who are participating in other clinical trials believe that other reasons are not appropriate for clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meniscus Injured patients<br>hESC Derived MSC Like Cell | Biological: hESC derived MSC like cell<br>* Different dosage of hESC derived MSC like cell for the meniscus injured patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |