Very Small Embryonic-like Stem Cells for Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Autologous Very Small Embryonic-like Stem Cells(VSELs) for Knee Osteoarthritis

Conditions
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Stem Cell Transplant Complications, Knee Osteoarthritis

Intervention / Treatment
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* Biological: very small embryonic-like stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients had moderate to severe osteoarthritis of both knees. Those had mechanical pain of knee joints, which was aggravated by walking or stair climbing. Those complained of gelling pain of knee joint. Those have crepitus and limitation of the joint range of motion with joint bony hypertrophy on physical examination, X-rays showed narrowing of joint space and osteophyte formation Exclusion Criteria: Diabetic foot and patients with obvious edema in the legs caused by various causes Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three experimental groups were injected with different doses of VSEL, and the control group was injected with platelet-containing serum that dissolved VSEL.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSEL Max<br>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 | Biological: very small embryonic-like stem cell<br>* 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<br>* Other names: VSEL;|
| Experimental: VSEL Medium<br>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 | Biological: very small embryonic-like stem cell<br>* 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<br>* Other names: VSEL;|
| Experimental: VSEL Mini<br>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 | Biological: very small embryonic-like stem cell<br>* 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<br>* Other names: VSEL;|
| No Intervention: Control<br>A mean volume of 5.5 mL platelet-rich plasma containing no VSELs injected into the selected knee of the patient | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |