Meniscus Injury
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALhESC derived MSC like cell
Different dosage of hESC derived MSC like cell for the meniscus injured patients
Sponsors
Chinese Academy of Sciences
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events | 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell | Adverse events include：allergic reactions, local reactions or infections at the injection site and muscle or skeletal dysplasia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score for pain（VAS） | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell | 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. |
| Range of knee motion | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell | to use the goniometer to measure the range of knee motion |
| Lysholm Knee Scale | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell | 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). |
| Ultrasound of knee joint | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell | Ultrasound of knee joint |
| Global posture analysis system | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell | to test the static balance |
| Dynamic balance test | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell | Use the dynamic posture evaluator |
| MRI of knee | baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell | MRI of knee |
Countries
China
Outcome results
None listed