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Policy changes have contributed to the failure to carry out smoothly
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| Name | Class |
|---|---|
| Guangzhou Four-Leaf Clover HealthTech Co., Ltd. | INDUSTRY |
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The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to knee osteoarthritis.
VSELs come from the patient's peripheral blood, and will be injected in the most painful knee, or the worse knee on physical examination. Then follow-up the knee pain and imaging changes at 6 months and 1 year after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSEL Max | Experimental | A mean volume of 5.5 mL platelet-rich plasma containing approximately 120,000 cells were prepared and injected into the selected knee of the patient |
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| VSEL Medium | Experimental | A mean volume of 5.5 mL platelet-rich plasma containing approximately 90,000 cells were prepared and injected into the selected knee of the patient |
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| VSEL Mini | Experimental | A mean volume of 5.5 mL platelet-rich plasma containing approximately 60,000 cells were prepared and injected into the selected knee of the patient |
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| Control | No Intervention | A mean volume of 5.5 mL platelet-rich plasma containing no VSELs injected into the selected knee of the patient |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| very small embryonic-like stem cell | Biological | Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation |
| Measure | Description | Time Frame |
|---|---|---|
| Change of knee pain score | Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep | 2-4 weeks after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change of knee pain score | Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep | 6 months after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biological treatment center in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Three experimental groups were injected with different doses of VSEL, and the control group was injected with platelet-containing serum that dissolved VSEL.
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The investigators screen patients with similar knee condition to ensure a small difference, and they randomized different numbers of VSELs to the patients.
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| Imaging changes in the knee joint | Magnetic resonance image (MRI) examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage | 6 months after injection |
| Change of knee pain score | Pain assessment by visual analogue score (VAS). 0 point: no pain; 1-3 points: there is a slight pain that can be tolerated; 4-6 points: the patient has pain and affects sleep, and can still bear it; 7-10 points: the patient has progressively strong pain, pain is unbearable, affecting appetite and sleep | 12 months after injection |
| Imaging changes in the knee joint | MRI examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage | 12 months after injection |
| D012216 |
| Rheumatic Diseases |