Autologous Very Small Embryonic-like Stem Cells(VSELs) for Knee Osteoarthritis
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Change of knee pain score
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 50 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
VSEL Max
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
Intervention: very small embryonic-like stem cell (Biological)
VSEL Medium
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
Intervention: very small embryonic-like stem cell (Biological)
VSEL Mini
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
Intervention: very small embryonic-like stem cell (Biological)
Control
A mean volume of 5.5 mL platelet-rich plasma containing no VSELs injected into the selected knee of the patient
Outcomes
Primary Outcomes
Change of knee pain score
Time Frame: 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 Outcomes
- Imaging changes in the knee joint(12 months after injection)
- Change of knee pain score(12 months after injection)
- Change of knee pain score(6 months after injection)
- Imaging changes in the knee joint(6 months after injection)