Knee Osteoarthritis, Stem Cell Transplant Complications
Conditions
Brief summary
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to knee osteoarthritis.
Detailed description
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.
Interventions
BIOLOGICALvery small embryonic-like stem cell
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
Sponsors
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The investigators screen patients with similar knee condition to ensure a small difference, and they randomized different numbers of VSELs to the patients.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of knee pain score | 2-4 weeks after injection | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of knee pain score | 6 months after injection | 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 |
| Imaging changes in the knee joint | 6 months after injection | Magnetic resonance image (MRI) examination of the smoothness of the knee joint surface, ligament, soft tissue and meniscus damage |
Countries
China
Outcome results
None listed